Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-03-13 @ 9:21 PM
Study NCT ID:
NCT01963793
Status:
COMPLETED
Last Update Posted:
2025-03-10
First Post:
2013-09-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Topical Aprepitant in Prurigo Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011537', 'term': 'Pruritus'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077608', 'term': 'Aprepitant'}], 'ancestors': [{'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'disclosure@leo-pharma.com', 'phone': '+45 4494 5888', 'title': 'Clinical Trial Disclosure Manager', 'organization': 'LEO Pharma A/S'}, 'certainAgreement': {'otherDetails': 'Prior to submitting or presenting a manuscript relating to the clinical trial to a publisher, reviewer or other outside person, the Investigator shall submit to LEO, in writing, a copy of the intended publication, describing the detail of any Research Results that the Investigator intends to Publish, at least 60 days before the date of the proposed submission for publication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From Day 1 to Day 42', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment Not Defined', 'description': 'The treatment for these adverse events are not defined', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 10, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Aprepitant Gel Vehicle', 'description': 'Placebo (Aprepitant gel vehicle)', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 15, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Aprepitant Gel', 'description': '10 mg/g aprepitant gel', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 11, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Application site discolouration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Application site discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Application site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Application site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Application site nodule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Application site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Application site paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Application site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Application site urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Application site vesicles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Sneezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dermatitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Skin burning sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Wound treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pruritus by VAS (Visual Analogue Scale)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant 10 mg/g Gel', 'description': '20 participants treated with aprepitant 10mg/g gel on either left or right extremity'}, {'id': 'OG001', 'title': 'Aprepitant Gel Vehicle', 'description': '20 participants were treated with vehicle gel on either left or right extremity'}], 'classes': [{'categories': [{'measurements': [{'value': '19.7', 'groupId': 'OG000', 'lowerLimit': '9.5', 'upperLimit': '29.8'}, {'value': '21.2', 'groupId': 'OG001', 'lowerLimit': '11.1', 'upperLimit': '31.4'}]}]}], 'analyses': [{'pValue': '0.58', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.51', 'ciLowerLimit': '-7.12', 'ciUpperLimit': '4.11', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At end of treatment (Day 28)', 'description': 'At end of treatment (Day 28) participants assessed the intensity of present pruritus of each treated area on a visual analogue scale (VAS) with a score of "0" (no itch at all) to "10" (worst imaginable itch) at the two extremes on a 100 mm line.', 'unitOfMeasure': 'mm', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pruritus by VAS (Visual Analogue Scale)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant 10 mg/g Gel', 'description': '20 participants treated with aprepitant 10mg/g gel on either left or right extremity'}, {'id': 'OG001', 'title': 'Aprepitant Gel Vehicle', 'description': '20 participants were treated with vehicle gel on either left or right extremity'}], 'classes': [{'title': 'Day 1 (Visit 2)', 'categories': [{'measurements': [{'value': '50.8', 'spread': '26.6', 'groupId': 'OG000'}, {'value': '58.1', 'spread': '28.2', 'groupId': 'OG001'}]}]}, {'title': 'Day 14 (Visit 3)', 'categories': [{'measurements': [{'value': '27.1', 'spread': '24.2', 'groupId': 'OG000'}, {'value': '28.7', 'spread': '19.1', 'groupId': 'OG001'}]}]}, {'title': 'Day 28 (Visit 4)', 'categories': [{'measurements': [{'value': '19.0', 'spread': '21.0', 'groupId': 'OG000'}, {'value': '21.9', 'spread': '24.2', 'groupId': 'OG001'}]}]}, {'title': 'Day 42 (Visit 5)', 'categories': [{'measurements': [{'value': '23.9', 'spread': '28.2', 'groupId': 'OG000'}, {'value': '24.0', 'spread': '26.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline (Day 1), Day 14, end of treatment (Day 28), and Day 42', 'description': 'At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42, participants assessed the intensity of present pruritus of each treated area on a visual analogue scale (VAS) with a score of "0" (no itch at all) to "10" (worst imaginable itch) at the two extremes on a 100 mm line.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Participants' Global Assessment on Treatment Areas", 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant 10 mg/g Gel', 'description': '20 participants treated with aprepitant 10 mg/g gel on either left or right extremity'}, {'id': 'OG001', 'title': 'Aprepitant Gel Vehicle', 'description': '20 participants were treated with vehicle gel on either left or right extremity'}], 'classes': [{'title': 'Day 1 (Visit 2)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 14 (Visit 3)', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Day 28 (Visit 4)', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Day 42 (Visit 5)', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42', 'description': 'At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42, participants assessed their prurigo on each treated area using the following score: 0 = no symptoms, 1 = mild, 2 = moderate, 3 = severe. The change was calculated as the value at the later time point minus the value at baseline. The change at Day 1 was therefore 0 and negative values represent a decrease in score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Score Assessment of Crusting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant 10 mg/g Gel', 'description': '20 participants treated with aprepitant 10 mg/g gel on either left or right extremity'}, {'id': 'OG001', 'title': 'Aprepitant Gel Vehicle', 'description': '20 participants were treated with vehicle gel on either left or right extremity'}], 'classes': [{'title': 'Day 1 (Visit 2)', 'categories': [{'measurements': [{'value': '1.3', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Day 14 (Visit 3)', 'categories': [{'measurements': [{'value': '0.9', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Day 28 (Visit 4)', 'categories': [{'measurements': [{'value': '0.7', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Day 42 (Visit 5)', 'categories': [{'measurements': [{'value': '0.8', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '0.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42', 'description': 'The (sub)investigator assessed the clinical picture at each treated area at baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 using the following score:\n\nCriteria:\n\nCrusts\n\nEvaluation:\n\n0 = not existing\n\n1. = mild\n2. = moderate\n3. = severe\n\nThe score will be an integer on the scale 0-3.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Score Assessment of Erythema', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant 10 mg/g Gel', 'description': '20 participants treated with aprepitant 10 mg/g gel on either left or right extremity'}, {'id': 'OG001', 'title': 'Aprepitant Gel Vehicle', 'description': '20 participants were treated with vehicle gel on either left or right extremity'}], 'classes': [{'title': 'Day 1 (Visit 2)', 'categories': [{'measurements': [{'value': '2.0', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Day 14 (Visit 3)', 'categories': [{'measurements': [{'value': '1.8', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Day 28 (Visit 4)', 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Day 42 (Visit 5)', 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '0.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42', 'description': 'The (sub)investigator will assess the clinical picture at each treated area at baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 using the following score:\n\nCriteria:\n\nErythema\n\nEvaluation:\n\n0 = not existing\n\n1. = mild\n2. = moderate\n3. = severe\n\nThe score will be an integer on the scale 0-3.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Score Assessment of Scratch Artefacts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant 10 mg/g Gel', 'description': '20 participants treated with aprepitant 10 mg/g gel on either left or right extremity'}, {'id': 'OG001', 'title': 'Aprepitant Gel Vehicle', 'description': '20 participants were treated with vehicle gel on either left or right extremity'}], 'classes': [{'title': 'Day 1 (Visit 2)', 'categories': [{'measurements': [{'value': '1.7', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Day 14 (Visit 3)', 'categories': [{'measurements': [{'value': '1.3', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Day 28 (Visit 4)', 'categories': [{'measurements': [{'value': '1.1', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Day 42 (Visit 5)', 'categories': [{'measurements': [{'value': '1.4', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42', 'description': 'The (sub)investigator will assess the clinical picture at each treated area at baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 using the following score:\n\nCriteria:\n\nScratch artefacts: Superficial damage to the skin caused by severe scratching.\n\nEvaluation:\n\n0 = not existing\n\n1. = mild\n2. = moderate\n3. = severe\n\nThe score will be an integer on the scale 0-3.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Score Assessment of Infiltration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant 10 mg/g Gel', 'description': '20 participants treated with aprepitant 10 mg/g gel on either left or right extremity'}, {'id': 'OG001', 'title': 'Aprepitant Gel Vehicle', 'description': '20 participants were treated with vehicle gel on either left or right extremity'}], 'classes': [{'title': 'Day 1 (Visit 2)', 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Day 14 (Visit 3)', 'categories': [{'measurements': [{'value': '1.3', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Day 28 (Visit 4)', 'categories': [{'measurements': [{'value': '1.1', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 42 (Visit 5)', 'categories': [{'measurements': [{'value': '1.3', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '1.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42', 'description': 'The (sub)investigator will assess the clinical picture at each treated area at baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 using the following score:\n\nCriteria:\n\nInfiltration\n\nEvaluation:\n\n0 = not existing\n\n1. = mild\n2. = moderate\n3. = severe\n\nThe score will be an integer on the scale 0-3.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Transepidermal Water Loss (TEWL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant 10 mg/g Gel', 'description': '20 participants treated with aprepitant 10 mg/g gel on either left or right extremity'}, {'id': 'OG001', 'title': 'Aprepitant Gel Vehicle', 'description': '20 participants were treated with vehicle gel on either left or right extremity'}], 'classes': [{'title': 'Day 1 (Visit 2)', 'categories': [{'measurements': [{'value': '20.6', 'spread': '13.6', 'groupId': 'OG000'}, {'value': '25.2', 'spread': '12.8', 'groupId': 'OG001'}]}]}, {'title': 'Day 14 (Visit 3)', 'categories': [{'measurements': [{'value': '22.7', 'spread': '12.5', 'groupId': 'OG000'}, {'value': '24.0', 'spread': '12.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 28 (Visit 4)', 'categories': [{'measurements': [{'value': '20.0', 'spread': '19.5', 'groupId': 'OG000'}, {'value': '19.9', 'spread': '21.3', 'groupId': 'OG001'}]}]}, {'title': 'Day 42 (Visit 5)', 'categories': [{'measurements': [{'value': '19.4', 'spread': '13.2', 'groupId': 'OG000'}, {'value': '19.9', 'spread': '9.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42', 'description': 'The (sub)investigator will made the following clinical assessment:\n\nTransepidermal water loss was defined as amount of released water from skin surface in g/cm\\^2 per hour. The TEWL is increased in case of damage of skin barrier.', 'unitOfMeasure': 'g/cm² per hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Lesional Erythema by Mexameter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant 10 mg/g Gel', 'description': '20 participants treated with aprepitant 10 mg/g gel on either left or right extremity'}, {'id': 'OG001', 'title': 'Aprepitant Gel Vehicle', 'description': '20 participants were treated with vehicle gel on either left or right extremity'}], 'classes': [{'title': 'Day 1 (Visit 2)', 'categories': [{'measurements': [{'value': '438', 'spread': '124', 'groupId': 'OG000'}, {'value': '453', 'spread': '107', 'groupId': 'OG001'}]}]}, {'title': 'Day 14 (Visit 3)', 'categories': [{'measurements': [{'value': '527', 'spread': '122', 'groupId': 'OG000'}, {'value': '463', 'spread': '119', 'groupId': 'OG001'}]}]}, {'title': 'Day 28 (Visit 4)', 'categories': [{'measurements': [{'value': '464', 'spread': '114', 'groupId': 'OG000'}, {'value': '491', 'spread': '147', 'groupId': 'OG001'}]}]}, {'title': 'Day 42 (Visit 5)', 'categories': [{'measurements': [{'value': '457', 'spread': '120', 'groupId': 'OG000'}, {'value': '461', 'spread': '144', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42', 'description': 'The skin colour of the participants was evaluated by use of a Mexameter spectrophotometer. The instrument computed an erythema index (with a range between 0 and 999, where higher values indicate more erythema or redness) which may be used as an indication of skin properties.\n\nMexameter measurements were performed at baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 to assess stimulation of microcirculation, irritating effects, and occurring erythema.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Non-lesional Erythema by Mexameter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lateral Side of Aprepitant 10 mg/g Gel', 'description': '20 participants treated with aprepitant 10 mg/g gel on either left or right extremity'}, {'id': 'OG001', 'title': 'Lateral Side of Aprepitant Gel Vehicle', 'description': '20 participants were treated with vehicle gel on either left or right extremity'}], 'classes': [{'title': 'Day 1 (Visit 2)', 'categories': [{'measurements': [{'value': '304', 'spread': '151', 'groupId': 'OG000'}, {'value': '300', 'spread': '145', 'groupId': 'OG001'}]}]}, {'title': 'Day 14 (Visit 3)', 'categories': [{'measurements': [{'value': '287', 'spread': '84.6', 'groupId': 'OG000'}, {'value': '312', 'spread': '138', 'groupId': 'OG001'}]}]}, {'title': 'Day 28 (Visit 4)', 'categories': [{'measurements': [{'value': '262', 'spread': '104', 'groupId': 'OG000'}, {'value': '271', 'spread': '71.8', 'groupId': 'OG001'}]}]}, {'title': 'Day 42 (Visit 5)', 'categories': [{'measurements': [{'value': '284', 'spread': '79.5', 'groupId': 'OG000'}, {'value': '284', 'spread': '85.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42', 'description': 'The skin colour of the participants was evaluated by use of a Mexameter spectrophotometer. The instrument computed an erythema index (with a range between 0 and 999, where higher values indicate more erythema or redness) which may be used as an indication of skin properties.\n\nMexameter measurements were performed at baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 to assess stimulation of microcirculation, irritating effects, and occurring erythema.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Melanin by Mexameter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant 10 mg/g Gel', 'description': '20 participants treated with aprepitant 10 mg/g gel on either left or right extremity'}, {'id': 'OG001', 'title': 'Aprepitant Gel Vehicle', 'description': '20 participants were treated with vehicle gel on either left or right extremity'}], 'classes': [{'title': 'Day 1 (Visit 2)', 'categories': [{'measurements': [{'value': '131', 'spread': '61.6', 'groupId': 'OG000'}, {'value': '115', 'spread': '52.4', 'groupId': 'OG001'}]}]}, {'title': 'Day 14 (Visit 3)', 'categories': [{'measurements': [{'value': '121', 'spread': '43.8', 'groupId': 'OG000'}, {'value': '134', 'spread': '56.8', 'groupId': 'OG001'}]}]}, {'title': 'Day 28 (Visit 4)', 'categories': [{'measurements': [{'value': '152', 'spread': '51.7', 'groupId': 'OG000'}, {'value': '139', 'spread': '60.3', 'groupId': 'OG001'}]}]}, {'title': 'Day 42 (Visit 5)', 'categories': [{'measurements': [{'value': '132', 'spread': '73.2', 'groupId': 'OG000'}, {'value': '144', 'spread': '77.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42', 'description': 'The skin colour of the participants was evaluated by use of a Mexameter spectrophotometer. The instrument computed a melanin index (with a range between 0 and 999, where higher values indicate more melanin) which may be used as an indication of skin properties.\n\nMexameter measurements were performed at baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 to assess stimulation of microcirculation, irritating effects, and occurring erythema.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Non-lesional Melanin by Mexameter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant 10 mg/g Gel', 'description': '20 participants treated with aprepitant 10 mg/g gel on either left or right extremity'}, {'id': 'OG001', 'title': 'Aprepitant Gel Vehicle', 'description': '20 participants were treated with vehicle gel on either left or right extremity'}], 'classes': [{'title': 'Day 1 (Visit 2)', 'categories': [{'measurements': [{'value': '127', 'spread': '58.9', 'groupId': 'OG000'}, {'value': '129', 'spread': '49.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 14 (Visit 3)', 'categories': [{'measurements': [{'value': '165', 'spread': '179', 'groupId': 'OG000'}, {'value': '215', 'spread': '224', 'groupId': 'OG001'}]}]}, {'title': 'Day 28 (Visit 4)', 'categories': [{'measurements': [{'value': '149', 'spread': '117', 'groupId': 'OG000'}, {'value': '166', 'spread': '170', 'groupId': 'OG001'}]}]}, {'title': 'Day 42 (Visit 5)', 'categories': [{'measurements': [{'value': '129', 'spread': '51.3', 'groupId': 'OG000'}, {'value': '179', 'spread': '236', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42', 'description': 'The skin colour of the participants was evaluated by use of a Mexameter spectrophotometer. The instrument computed a melanin index (with a range between 0 and 999, where higher values indicate more melanin) which may be used as an indication of skin properties.\n\nMexameter measurements were performed at baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 to assess stimulation of microcirculation, irritating effects, and occurring erythema.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Daily Assessments of Duration of Pruritus (Preceding 12 Hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Evening: Aprepitant 10 mg/g Gel', 'description': '20 participants treated with aprepitant 10 mg/g gel on either left or right extremity'}, {'id': 'OG001', 'title': 'Evening: Aprepitant Gel Vehicle', 'description': '20 participants were treated with vehicle gel on either left or right extremity'}, {'id': 'OG002', 'title': 'Morning: Aprepitant 10 mg/g Gel', 'description': '20 participants treated with aprepitant 10 mg/g gel on either left or right extremity'}, {'id': 'OG003', 'title': 'Morning: Aprepitant Gel Vehicle', 'description': '20 participants were treated with vehicle gel on either left or right extremity'}], 'classes': [{'title': 'Day -1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.7', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '2.1', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': "Participants' assessments started on the evening of Day -1 so there is no morning data.", 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': "Participants' assessments started on the evening of Day -1 so there is no morning data.", 'groupId': 'OG003'}]}]}, {'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '1.6', 'groupId': 'OG001'}, {'value': '3.0', 'spread': '1.8', 'groupId': 'OG002'}, {'value': '3.4', 'spread': '1.8', 'groupId': 'OG003'}]}]}, {'title': 'Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.0', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '1.7', 'groupId': 'OG001'}, {'value': '3.2', 'spread': '1.2', 'groupId': 'OG002'}, {'value': '3.3', 'spread': '1.3', 'groupId': 'OG003'}]}]}, {'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.9', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '1.6', 'groupId': 'OG001'}, {'value': '2.9', 'spread': '1.1', 'groupId': 'OG002'}, {'value': '3.1', 'spread': '1.3', 'groupId': 'OG003'}]}]}, {'title': 'Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.7', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '2.8', 'spread': '1.4', 'groupId': 'OG002'}, {'value': '3.1', 'spread': '1.5', 'groupId': 'OG003'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.1', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '1.5', 'groupId': 'OG001'}, {'value': '2.2', 'spread': '1.2', 'groupId': 'OG002'}, {'value': '2.8', 'spread': '1.3', 'groupId': 'OG003'}]}]}, {'title': 'Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.5', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '2.3', 'spread': '1.3', 'groupId': 'OG002'}, {'value': '2.6', 'spread': '1.5', 'groupId': 'OG003'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.6', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '2.5', 'spread': '1.5', 'groupId': 'OG002'}, {'value': '2.7', 'spread': '1.6', 'groupId': 'OG003'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.4', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '1.5', 'groupId': 'OG001'}, {'value': '2.3', 'spread': '1.4', 'groupId': 'OG002'}, {'value': '2.6', 'spread': '1.5', 'groupId': 'OG003'}]}]}, {'title': 'Day 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.4', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '2.4', 'spread': '1.3', 'groupId': 'OG002'}, {'value': '2.8', 'spread': '1.3', 'groupId': 'OG003'}]}]}, {'title': 'Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.4', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '1.5', 'groupId': 'OG001'}, {'value': '2.4', 'spread': '1.3', 'groupId': 'OG002'}, {'value': '2.5', 'spread': '1.4', 'groupId': 'OG003'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '1.5', 'groupId': 'OG001'}, {'value': '2.0', 'spread': '1.3', 'groupId': 'OG002'}, {'value': '2.4', 'spread': '1.4', 'groupId': 'OG003'}]}]}, {'title': 'Day 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.1', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '2.2', 'spread': '1.3', 'groupId': 'OG002'}, {'value': '2.7', 'spread': '1.3', 'groupId': 'OG003'}]}]}, {'title': 'Day 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.4', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '1.5', 'groupId': 'OG001'}, {'value': '2.2', 'spread': '1.5', 'groupId': 'OG002'}, {'value': '2.5', 'spread': '1.4', 'groupId': 'OG003'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.1', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '2.1', 'spread': '1.4', 'groupId': 'OG002'}, {'value': '2.4', 'spread': '1.3', 'groupId': 'OG003'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.4', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '2.1', 'spread': '1.5', 'groupId': 'OG002'}, {'value': '2.5', 'spread': '1.4', 'groupId': 'OG003'}]}]}, {'title': 'Day 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '2.1', 'spread': '1.2', 'groupId': 'OG002'}, {'value': '2.6', 'spread': '1.2', 'groupId': 'OG003'}]}]}, {'title': 'Day 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '2.1', 'spread': '1.4', 'groupId': 'OG002'}, {'value': '2.6', 'spread': '1.4', 'groupId': 'OG003'}]}]}, {'title': 'Day 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.1', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '2.2', 'spread': '1.3', 'groupId': 'OG002'}, {'value': '2.6', 'spread': '1.3', 'groupId': 'OG003'}]}]}, {'title': 'Day 19', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.1', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '1.9', 'spread': '1.3', 'groupId': 'OG002'}, {'value': '2.3', 'spread': '1.4', 'groupId': 'OG003'}]}]}, {'title': 'Day 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '2.0', 'spread': '1.2', 'groupId': 'OG002'}, {'value': '2.2', 'spread': '1.2', 'groupId': 'OG003'}]}]}, {'title': 'Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '1.9', 'spread': '1.3', 'groupId': 'OG002'}, {'value': '2.1', 'spread': '1.2', 'groupId': 'OG003'}]}]}, {'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.9', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '2.0', 'spread': '1.3', 'groupId': 'OG002'}, {'value': '2.2', 'spread': '1.2', 'groupId': 'OG003'}]}]}, {'title': 'Day 23', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.3', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '1.5', 'groupId': 'OG001'}, {'value': '2.0', 'spread': '1.2', 'groupId': 'OG002'}, {'value': '2.3', 'spread': '1.2', 'groupId': 'OG003'}]}]}, {'title': 'Day 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.9', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '2.0', 'spread': '1.2', 'groupId': 'OG002'}, {'value': '2.1', 'spread': '1.2', 'groupId': 'OG003'}]}]}, {'title': 'Day 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.3', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '1.9', 'spread': '1.2', 'groupId': 'OG002'}, {'value': '2.1', 'spread': '1.3', 'groupId': 'OG003'}]}]}, {'title': 'Day 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '2.4', 'spread': '1.5', 'groupId': 'OG002'}, {'value': '2.3', 'spread': '1.5', 'groupId': 'OG003'}]}]}, {'title': 'Day 27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '2.1', 'spread': '1.2', 'groupId': 'OG002'}, {'value': '2.2', 'spread': '1.2', 'groupId': 'OG003'}]}]}, {'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.8', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '2.0', 'spread': '1.2', 'groupId': 'OG002'}, {'value': '2.1', 'spread': '1.2', 'groupId': 'OG003'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '0.0', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '1.2', 'groupId': 'OG002'}, {'value': '1.7', 'spread': '1.2', 'groupId': 'OG003'}]}]}, {'title': 'Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': 'NA', 'comment': 'This value has not been calculated because only one person was analyzed.', 'groupId': 'OG000'}, {'value': '2.0', 'spread': 'NA', 'comment': 'This value has not been calculated because only one person was analyzed.', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '0.0', 'groupId': 'OG002'}, {'value': '1.5', 'spread': '0.7', 'groupId': 'OG003'}]}]}, {'title': 'Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': "Participants' assessments ended on the morning of Day 31 so there is no evening data.", 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': "Participants' assessments ended on the morning of Day 31 so there is no evening data.", 'groupId': 'OG001'}, {'value': '1.0', 'spread': 'NA', 'comment': 'This value has not been calculated because only one person was analyzed.', 'groupId': 'OG002'}, {'value': '2.0', 'spread': 'NA', 'comment': 'This value has not been calculated because only one person was analyzed.', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Day 31', 'description': 'During the trial participants completed a diary twice daily, in the morning and in the evening, each covering the preceding 12 hours, which collected the number of hours with pruritus within the last 12 hours on both areas by use of a 7-point scale (\\<0.5 hours, 0.5-1 hours, 1-2 hours, 3-4 hours, 5-6 hours, 7-8 hours, 9-12 hours).\n\nDuration of pruritus was categorized as follows: 1 if \\<0.5 hours, 2 if 0.5-1 hours, 3 if 1-2 hours, 4 if 3-4 hours, 5 if 5-6 hours, 6 if 7-8 hours and 7 if 9-12 hours.\n\nThe evening baseline measure was taken on the evening of Day -1 and the morning baseline measure was taken on the morning of Day 1 before cream was applied.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Results were collected from a diary that participants were requested to fill in twice a day. Some participants missed some of the entries so there are less than 19 participants analysed for some of the time points.'}, {'type': 'SECONDARY', 'title': 'Daily Assessments of Average Pruritus by Use of a VAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Evening: Aprepitant 10 mg/g Gel', 'description': '20 participants treated with aprepitant 10 mg/g gel on either left or right extremity'}, {'id': 'OG001', 'title': 'Evening: Aprepitant Gel Vehicle', 'description': '20 participants were treated with vehicle gel on either left or right extremity'}, {'id': 'OG002', 'title': 'Morning: Aprepitant 10 mg/g Gel', 'description': '20 participants treated with aprepitant 10 mg/g gel on either left or right extremity'}, {'id': 'OG003', 'title': 'Morning: Aprepitant Gel Vehicle', 'description': '20 participants were treated with vehicle gel on either left or right extremity'}], 'classes': [{'title': 'Day -1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '49.1', 'spread': '20.9', 'groupId': 'OG000'}, {'value': '51.3', 'spread': '21.1', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': "Participants' assessments started on the evening of Day -1 so there is no morning data.", 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': "Participants' assessments started on the evening of Day -1 so there is no morning data.", 'groupId': 'OG003'}]}]}, {'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '45.0', 'spread': '21.5', 'groupId': 'OG000'}, {'value': '44.7', 'spread': '21.7', 'groupId': 'OG001'}, {'value': '46.9', 'spread': '21.6', 'groupId': 'OG002'}, {'value': '49.3', 'spread': '20.6', 'groupId': 'OG003'}]}]}, {'title': 'Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '35.1', 'spread': '24.1', 'groupId': 'OG000'}, {'value': '38.9', 'spread': '22.2', 'groupId': 'OG001'}, {'value': '38.3', 'spread': '18.4', 'groupId': 'OG002'}, {'value': '39.2', 'spread': '19.0', 'groupId': 'OG003'}]}]}, {'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '33.7', 'spread': '21.0', 'groupId': 'OG000'}, {'value': '35.8', 'spread': '20.4', 'groupId': 'OG001'}, {'value': '33.6', 'spread': '21.0', 'groupId': 'OG002'}, {'value': '33.7', 'spread': '19.7', 'groupId': 'OG003'}]}]}, {'title': 'Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '31.8', 'spread': '20.2', 'groupId': 'OG000'}, {'value': '37.5', 'spread': '18.3', 'groupId': 'OG001'}, {'value': '34.5', 'spread': '22.1', 'groupId': 'OG002'}, {'value': '37.2', 'spread': '18.7', 'groupId': 'OG003'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '27.4', 'spread': '19.6', 'groupId': 'OG000'}, {'value': '31.0', 'spread': '18.0', 'groupId': 'OG001'}, {'value': '24.2', 'spread': '16.3', 'groupId': 'OG002'}, {'value': '33.7', 'spread': '16.9', 'groupId': 'OG003'}]}]}, {'title': 'Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '26.4', 'spread': '15.9', 'groupId': 'OG000'}, {'value': '31.5', 'spread': '17.6', 'groupId': 'OG001'}, {'value': '26.8', 'spread': '17.4', 'groupId': 'OG002'}, {'value': '30.3', 'spread': '19.1', 'groupId': 'OG003'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '30.4', 'spread': '21.7', 'groupId': 'OG000'}, {'value': '33.2', 'spread': '22.2', 'groupId': 'OG001'}, {'value': '28.3', 'spread': '20.9', 'groupId': 'OG002'}, {'value': '31.9', 'spread': '21.9', 'groupId': 'OG003'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '23.3', 'spread': '12.6', 'groupId': 'OG000'}, {'value': '28.8', 'spread': '16.1', 'groupId': 'OG001'}, {'value': '26.5', 'spread': '18.4', 'groupId': 'OG002'}, {'value': '30.1', 'spread': '18.8', 'groupId': 'OG003'}]}]}, {'title': 'Day 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '24.5', 'spread': '16.6', 'groupId': 'OG000'}, {'value': '27.6', 'spread': '17.9', 'groupId': 'OG001'}, {'value': '26.8', 'spread': '17.1', 'groupId': 'OG002'}, {'value': '27.4', 'spread': '16.0', 'groupId': 'OG003'}]}]}, {'title': 'Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '22.0', 'spread': '14.8', 'groupId': 'OG000'}, {'value': '28.2', 'spread': '17.7', 'groupId': 'OG001'}, {'value': '30.6', 'spread': '21.6', 'groupId': 'OG002'}, {'value': '30.2', 'spread': '20.6', 'groupId': 'OG003'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '23.3', 'spread': '18.8', 'groupId': 'OG000'}, {'value': '28.4', 'spread': '19.1', 'groupId': 'OG001'}, {'value': '22.3', 'spread': '15.2', 'groupId': 'OG002'}, {'value': '29.3', 'spread': '19.0', 'groupId': 'OG003'}]}]}, {'title': 'Day 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '19.9', 'spread': '13.4', 'groupId': 'OG000'}, {'value': '23.7', 'spread': '12.6', 'groupId': 'OG001'}, {'value': '23.0', 'spread': '17.0', 'groupId': 'OG002'}, {'value': '27.8', 'spread': '16.8', 'groupId': 'OG003'}]}]}, {'title': 'Day 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '21.8', 'spread': '26.0', 'groupId': 'OG000'}, {'value': '26.4', 'spread': '14.8', 'groupId': 'OG001'}, {'value': '20.2', 'spread': '13.4', 'groupId': 'OG002'}, {'value': '23.4', 'spread': '14.5', 'groupId': 'OG003'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '20.9', 'spread': '15.4', 'groupId': 'OG000'}, {'value': '23.1', 'spread': '13.7', 'groupId': 'OG001'}, {'value': '21.9', 'spread': '15.1', 'groupId': 'OG002'}, {'value': '24.7', 'spread': '16.1', 'groupId': 'OG003'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '24.2', 'spread': '16.9', 'groupId': 'OG000'}, {'value': '25.2', 'spread': '16.0', 'groupId': 'OG001'}, {'value': '19.3', 'spread': '14.6', 'groupId': 'OG002'}, {'value': '22.1', 'spread': '13.0', 'groupId': 'OG003'}]}]}, {'title': 'Day 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '20.8', 'spread': '13.6', 'groupId': 'OG000'}, {'value': '24.3', 'spread': '16.7', 'groupId': 'OG001'}, {'value': '22.7', 'spread': '15.4', 'groupId': 'OG002'}, {'value': '25.4', 'spread': '15.3', 'groupId': 'OG003'}]}]}, {'title': 'Day 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '20.2', 'spread': '14.6', 'groupId': 'OG000'}, {'value': '21.7', 'spread': '14.8', 'groupId': 'OG001'}, {'value': '18.8', 'spread': '14.4', 'groupId': 'OG002'}, {'value': '22.8', 'spread': '14.3', 'groupId': 'OG003'}]}]}, {'title': 'Day 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '18.5', 'spread': '13.6', 'groupId': 'OG000'}, {'value': '21.1', 'spread': '14.5', 'groupId': 'OG001'}, {'value': '21.6', 'spread': '13.9', 'groupId': 'OG002'}, {'value': '22.8', 'spread': '13.0', 'groupId': 'OG003'}]}]}, {'title': 'Day 19', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15.6', 'spread': '11.2', 'groupId': 'OG000'}, {'value': '19.9', 'spread': '16.0', 'groupId': 'OG001'}, {'value': '20.7', 'spread': '14.9', 'groupId': 'OG002'}, {'value': '22.4', 'spread': '14.7', 'groupId': 'OG003'}]}]}, {'title': 'Day 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '16.0', 'spread': '11.9', 'groupId': 'OG000'}, {'value': '19.7', 'spread': '12.9', 'groupId': 'OG001'}, {'value': '17.8', 'spread': '13.1', 'groupId': 'OG002'}, {'value': '18.6', 'spread': '14.9', 'groupId': 'OG003'}]}]}, {'title': 'Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '14.5', 'spread': '14.6', 'groupId': 'OG000'}, {'value': '17.0', 'spread': '16.4', 'groupId': 'OG001'}, {'value': '16.1', 'spread': '13.2', 'groupId': 'OG002'}, {'value': '17.1', 'spread': '12.4', 'groupId': 'OG003'}]}]}, {'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '14.3', 'spread': '13.2', 'groupId': 'OG000'}, {'value': '15.9', 'spread': '15.1', 'groupId': 'OG001'}, {'value': '15.3', 'spread': '14.4', 'groupId': 'OG002'}, {'value': '16.6', 'spread': '12.8', 'groupId': 'OG003'}]}]}, {'title': 'Day 23', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15.6', 'spread': '13.6', 'groupId': 'OG000'}, {'value': '17.2', 'spread': '14.3', 'groupId': 'OG001'}, {'value': '15.8', 'spread': '16.0', 'groupId': 'OG002'}, {'value': '14.6', 'spread': '12.7', 'groupId': 'OG003'}]}]}, {'title': 'Day 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15.7', 'spread': '14.1', 'groupId': 'OG000'}, {'value': '16.7', 'spread': '15.1', 'groupId': 'OG001'}, {'value': '16.5', 'spread': '16.6', 'groupId': 'OG002'}, {'value': '15.5', 'spread': '13.4', 'groupId': 'OG003'}]}]}, {'title': 'Day 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '18.2', 'spread': '16.4', 'groupId': 'OG000'}, {'value': '16.8', 'spread': '14.0', 'groupId': 'OG001'}, {'value': '15.8', 'spread': '14.8', 'groupId': 'OG002'}, {'value': '16.5', 'spread': '17.0', 'groupId': 'OG003'}]}]}, {'title': 'Day 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15.1', 'spread': '13.1', 'groupId': 'OG000'}, {'value': '16.6', 'spread': '15.8', 'groupId': 'OG001'}, {'value': '19.8', 'spread': '17.3', 'groupId': 'OG002'}, {'value': '16.3', 'spread': '13.5', 'groupId': 'OG003'}]}]}, {'title': 'Day 27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '14.2', 'spread': '15.4', 'groupId': 'OG000'}, {'value': '14.1', 'spread': '12.9', 'groupId': 'OG001'}, {'value': '13.6', 'spread': '13.8', 'groupId': 'OG002'}, {'value': '14.6', 'spread': '13.0', 'groupId': 'OG003'}]}]}, {'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.8', 'spread': '7.5', 'groupId': 'OG000'}, {'value': '11.6', 'spread': '10.6', 'groupId': 'OG001'}, {'value': '16.4', 'spread': '14.5', 'groupId': 'OG002'}, {'value': '14.9', 'spread': '13.5', 'groupId': 'OG003'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.0', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '2.1', 'groupId': 'OG001'}, {'value': '4.7', 'spread': '6.1', 'groupId': 'OG002'}, {'value': '4.9', 'spread': '5.6', 'groupId': 'OG003'}]}]}, {'title': 'Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.0', 'spread': 'NA', 'comment': 'This value has not been calculated because only one person was analyzed.', 'groupId': 'OG000'}, {'value': '3.0', 'spread': 'NA', 'comment': 'This value has not been calculated because only one person was analyzed.', 'groupId': 'OG001'}, {'value': '3.5', 'spread': '2.1', 'groupId': 'OG002'}, {'value': '3.5', 'spread': '0.7', 'groupId': 'OG003'}]}]}, {'title': 'Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': "Participants' assessments ended on the morning of Day 31 so there is no evening data.", 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': "Participants' assessments ended on the morning of Day 31 so there is no evening data.", 'groupId': 'OG001'}, {'value': '2.0', 'spread': 'NA', 'comment': 'This value has not been calculated because only one person was analyzed.', 'groupId': 'OG002'}, {'value': '2.0', 'spread': 'NA', 'comment': 'This value has not been calculated because only one person was analyzed.', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Day 31', 'description': 'During the trial participants completed a diary twice daily, in the morning and in the evening, each covering the preceding 12 hours, which collected the average intensity of pruritus since last evaluation by use of a VAS (ranging from 0 to 100). The participants assessed the intensity of present pruritus of each treated area on a visual analogue scale (VAS) with a score of "0" (no itch at all) to "10" (worst imaginable itch) at the two extremes on a 100 mm line.\n\nThe evening baseline measure was taken on the evening of Day -1 and the morning baseline measure was taken on the morning of Day 1, before cream was applied.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Results were collected from a diary that participants were requested to fill in twice a day. Some participants missed some of the entries so there are less than 20 participants analysed for some of the time points.'}, {'type': 'SECONDARY', 'title': 'Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Evening: Aprepitant 10 mg/g Gel', 'description': '20 participants were treated with vehicle gel on either left or right extremity'}, {'id': 'OG001', 'title': 'Evening: Aprepitant Gel Vehicle', 'description': '20 participants were treated with vehicle gel on either left or right extremity'}, {'id': 'OG002', 'title': 'Morning: Aprepitant 10 mg/g Gel', 'description': '20 participants treated with aprepitant 10 mg/g gel on either left or right extremity'}, {'id': 'OG003', 'title': 'Morning: Aprepitant Gel Vehicle', 'description': '20 participants were treated with vehicle gel on either left or right extremity'}], 'classes': [{'title': 'Day -1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '61.1', 'spread': '21.8', 'groupId': 'OG000'}, {'value': '62.7', 'spread': '25.7', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': "Participants' assessments started on the evening of Day -1 so there is no morning data.", 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': "Participants' assessments started on the evening of Day -1 so there is no morning data.", 'groupId': 'OG003'}]}]}, {'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '49.9', 'spread': '25.4', 'groupId': 'OG000'}, {'value': '54.7', 'spread': '24.6', 'groupId': 'OG001'}, {'value': '56.0', 'spread': '25.3', 'groupId': 'OG002'}, {'value': '62.4', 'spread': '22.0', 'groupId': 'OG003'}]}]}, {'title': 'Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '43.2', 'spread': '24.7', 'groupId': 'OG000'}, {'value': '46.7', 'spread': '25.1', 'groupId': 'OG001'}, {'value': '48.8', 'spread': '22.2', 'groupId': 'OG002'}, {'value': '46.7', 'spread': '23.0', 'groupId': 'OG003'}]}]}, {'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '41.6', 'spread': '24.7', 'groupId': 'OG000'}, {'value': '42.7', 'spread': '24.8', 'groupId': 'OG001'}, {'value': '39.5', 'spread': '24.5', 'groupId': 'OG002'}, {'value': '43.6', 'spread': '23.5', 'groupId': 'OG003'}]}]}, {'title': 'Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '37.7', 'spread': '21.7', 'groupId': 'OG000'}, {'value': '42.8', 'spread': '19.9', 'groupId': 'OG001'}, {'value': '39.5', 'spread': '25.1', 'groupId': 'OG002'}, {'value': '47.7', 'spread': '20.7', 'groupId': 'OG003'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '33.4', 'spread': '23.4', 'groupId': 'OG000'}, {'value': '39.7', 'spread': '23.6', 'groupId': 'OG001'}, {'value': '32.3', 'spread': '20.1', 'groupId': 'OG002'}, {'value': '41.7', 'spread': '21.9', 'groupId': 'OG003'}]}]}, {'title': 'Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '34.1', 'spread': '19.5', 'groupId': 'OG000'}, {'value': '38.4', 'spread': '21.0', 'groupId': 'OG001'}, {'value': '34.3', 'spread': '21.1', 'groupId': 'OG002'}, {'value': '39.1', 'spread': '24.5', 'groupId': 'OG003'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '35.2', 'spread': '23.5', 'groupId': 'OG000'}, {'value': '39.2', 'spread': '24.2', 'groupId': 'OG001'}, {'value': '35.3', 'spread': '23.5', 'groupId': 'OG002'}, {'value': '38.9', 'spread': '24.5', 'groupId': 'OG003'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '31.4', 'spread': '16.1', 'groupId': 'OG000'}, {'value': '37.4', 'spread': '19.5', 'groupId': 'OG001'}, {'value': '32.2', 'spread': '20.3', 'groupId': 'OG002'}, {'value': '40.7', 'spread': '23.0', 'groupId': 'OG003'}]}]}, {'title': 'Day 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '32.0', 'spread': '20.0', 'groupId': 'OG000'}, {'value': '35.0', 'spread': '21.5', 'groupId': 'OG001'}, {'value': '32.8', 'spread': '18.8', 'groupId': 'OG002'}, {'value': '35.9', 'spread': '18.5', 'groupId': 'OG003'}]}]}, {'title': 'Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '29.4', 'spread': '18.0', 'groupId': 'OG000'}, {'value': '34.5', 'spread': '19.7', 'groupId': 'OG001'}, {'value': '40.0', 'spread': '22.8', 'groupId': 'OG002'}, {'value': '41.1', 'spread': '22.5', 'groupId': 'OG003'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '30.7', 'spread': '22.4', 'groupId': 'OG000'}, {'value': '37.3', 'spread': '23.0', 'groupId': 'OG001'}, {'value': '28.7', 'spread': '17.8', 'groupId': 'OG002'}, {'value': '36.8', 'spread': '21.1', 'groupId': 'OG003'}]}]}, {'title': 'Day 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '27.1', 'spread': '17.2', 'groupId': 'OG000'}, {'value': '31.8', 'spread': '16.8', 'groupId': 'OG001'}, {'value': '31.6', 'spread': '22.8', 'groupId': 'OG002'}, {'value': '38.6', 'spread': '20.8', 'groupId': 'OG003'}]}]}, {'title': 'Day 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '31.0', 'spread': '21.9', 'groupId': 'OG000'}, {'value': '34.2', 'spread': '21.8', 'groupId': 'OG001'}, {'value': '29.1', 'spread': '21.7', 'groupId': 'OG002'}, {'value': '31.3', 'spread': '21.3', 'groupId': 'OG003'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '27.1', 'spread': '19.6', 'groupId': 'OG000'}, {'value': '31.2', 'spread': '19.0', 'groupId': 'OG001'}, {'value': '30.7', 'spread': '21.2', 'groupId': 'OG002'}, {'value': '31.9', 'spread': '21.7', 'groupId': 'OG003'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '29.4', 'spread': '19.0', 'groupId': 'OG000'}, {'value': '32.1', 'spread': '18.9', 'groupId': 'OG001'}, {'value': '26.3', 'spread': '19.1', 'groupId': 'OG002'}, {'value': '30.7', 'spread': '19.3', 'groupId': 'OG003'}]}]}, {'title': 'Day 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '28.2', 'spread': '16.8', 'groupId': 'OG000'}, {'value': '32.8', 'spread': '18.3', 'groupId': 'OG001'}, {'value': '29.1', 'spread': '18.9', 'groupId': 'OG002'}, {'value': '32.9', 'spread': '19.5', 'groupId': 'OG003'}]}]}, {'title': 'Day 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '28.2', 'spread': '19.1', 'groupId': 'OG000'}, {'value': '29.3', 'spread': '21.8', 'groupId': 'OG001'}, {'value': '25.5', 'spread': '16.7', 'groupId': 'OG002'}, {'value': '29.8', 'spread': '17.1', 'groupId': 'OG003'}]}]}, {'title': 'Day 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '25.6', 'spread': '16.2', 'groupId': 'OG000'}, {'value': '27.7', 'spread': '17.1', 'groupId': 'OG001'}, {'value': '29.2', 'spread': '18.5', 'groupId': 'OG002'}, {'value': '30.4', 'spread': '16.8', 'groupId': 'OG003'}]}]}, {'title': 'Day 19', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '24.1', 'spread': '15.7', 'groupId': 'OG000'}, {'value': '27.4', 'spread': '19.8', 'groupId': 'OG001'}, {'value': '27.7', 'spread': '20.2', 'groupId': 'OG002'}, {'value': '33.1', 'spread': '21.7', 'groupId': 'OG003'}]}]}, {'title': 'Day 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '25.1', 'spread': '17.4', 'groupId': 'OG000'}, {'value': '27.1', 'spread': '18.0', 'groupId': 'OG001'}, {'value': '23.2', 'spread': '14.5', 'groupId': 'OG002'}, {'value': '23.5', 'spread': '17.6', 'groupId': 'OG003'}]}]}, {'title': 'Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '21.3', 'spread': '19.5', 'groupId': 'OG000'}, {'value': '23.0', 'spread': '19.0', 'groupId': 'OG001'}, {'value': '22.6', 'spread': '16.2', 'groupId': 'OG002'}, {'value': '25.7', 'spread': '19.7', 'groupId': 'OG003'}]}]}, {'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '20.8', 'spread': '19.5', 'groupId': 'OG000'}, {'value': '21.5', 'spread': '16.7', 'groupId': 'OG001'}, {'value': '20.1', 'spread': '16.8', 'groupId': 'OG002'}, {'value': '22.7', 'spread': '15.1', 'groupId': 'OG003'}]}]}, {'title': 'Day 23', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '22.2', 'spread': '17.9', 'groupId': 'OG000'}, {'value': '24.2', 'spread': '18.0', 'groupId': 'OG001'}, {'value': '23.2', 'spread': '22.3', 'groupId': 'OG002'}, {'value': '21.1', 'spread': '16.7', 'groupId': 'OG003'}]}]}, {'title': 'Day 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '21.1', 'spread': '18.4', 'groupId': 'OG000'}, {'value': '22.0', 'spread': '19.1', 'groupId': 'OG001'}, {'value': '20.8', 'spread': '17.5', 'groupId': 'OG002'}, {'value': '21.1', 'spread': '16.6', 'groupId': 'OG003'}]}]}, {'title': 'Day 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '22.7', 'spread': '19.3', 'groupId': 'OG000'}, {'value': '23.8', 'spread': '21.3', 'groupId': 'OG001'}, {'value': '21.8', 'spread': '20.1', 'groupId': 'OG002'}, {'value': '20.8', 'spread': '17.3', 'groupId': 'OG003'}]}]}, {'title': 'Day 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '23.2', 'spread': '18.4', 'groupId': 'OG000'}, {'value': '24.0', 'spread': '19.2', 'groupId': 'OG001'}, {'value': '24.1', 'spread': '20.2', 'groupId': 'OG002'}, {'value': '23.1', 'spread': '18.7', 'groupId': 'OG003'}]}]}, {'title': 'Day 27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '20.9', 'spread': '21.8', 'groupId': 'OG000'}, {'value': '23.1', 'spread': '21.3', 'groupId': 'OG001'}, {'value': '19.6', 'spread': '18.6', 'groupId': 'OG002'}, {'value': '21.3', 'spread': '18.8', 'groupId': 'OG003'}]}]}, {'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '12.6', 'spread': '11.9', 'groupId': 'OG000'}, {'value': '18.9', 'spread': '20.1', 'groupId': 'OG001'}, {'value': '24.7', 'spread': '19.9', 'groupId': 'OG002'}, {'value': '24.7', 'spread': '21.7', 'groupId': 'OG003'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '7.5', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '5.7', 'spread': '7.0', 'groupId': 'OG002'}, {'value': '5.9', 'spread': '4.3', 'groupId': 'OG003'}]}]}, {'title': 'Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': 'NA', 'comment': 'This value has not been calculated because only one person was analyzed.', 'groupId': 'OG000'}, {'value': '4.0', 'spread': 'NA', 'comment': 'This value has not been calculated because only one person was analyzed.', 'groupId': 'OG001'}, {'value': '4.5', 'spread': '0.7', 'groupId': 'OG002'}, {'value': '5.5', 'spread': '0.7', 'groupId': 'OG003'}]}]}, {'title': 'Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': "Participants' assessments ended on the morning of Day 31 so there is no evening data.", 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': "Participants' assessments ended on the morning of Day 31 so there is no evening data.", 'groupId': 'OG001'}, {'value': '3.0', 'spread': 'NA', 'comment': 'This value has not been calculated because only one person was analyzed.', 'groupId': 'OG002'}, {'value': '4.0', 'spread': 'NA', 'comment': 'This value has not been calculated because only one person was analyzed.', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Day 31', 'description': 'During the trial participants completed a diary twice daily, in the morning and in the evening, each covering the preceding 12 hours, which collected the maximum intensity of pruritus since last evaluation by use of a VAS (ranging from 0 to 100). The participants assessed the intensity of present pruritus of each treated area on a visual analogue scale (VAS) with a score of "0" (no itch at all) to "10" (worst imaginable itch) at the two extremes on a 100 mm line.\n\nThe evening baseline measure was taken on the evening of Day -1 and the morning baseline measure was taken on the morning of Day 1 before cream was applied.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Results were collected from a diary that participants were requested to fill in twice a day. Some participants missed some of the entries so there are less than 20 participants analysed for some of the time points.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Pruritis Assessed by VAS at End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant 10 mg/g Gel', 'description': '20 participants treated with aprepitant 10 mg/g gel on either left or right extremity'}, {'id': 'OG001', 'title': 'Aprepitant Gel Vehicle', 'description': '20 participants were treated with vehicle gel on either left or right extremity'}], 'classes': [{'categories': [{'measurements': [{'value': '50.8', 'spread': '28.1', 'groupId': 'OG000'}, {'value': '41.7', 'spread': '29.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 28', 'description': 'On the last day of treatment, participants assessed the change of pruritus compared to baseline in percentage by use of a VAS (ranging from 0 to 100). The participants assessed the intensity of present pruritus of each treated area on a visual analogue scale (VAS) with a score of "0" (no itch at all) to "10" (worst imaginable itch) at the two extremes on a 100 mm line.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aprepitant Gel / Aprepitant Gel Vehicle', 'description': 'Participants were treated with aprepitant on one extremity and vehicle gel on the other 1:1 thus acting as their own intra-individual controls 10 participants: LEFT: aprepitant 10 mg/g gel , RIGHT: vehicle gel and 10 participants: LEFT: vehicle gel RIGHT: aprepitant 10 mg/g gel'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Aprepitant Gel / Aprepitant Gel Vehicle', 'description': 'All 20 randomised participants were divided into two groups 1:1 10 with LEFT: aprepitant 10 mg/g gel and RIGHT: vehicle gel and 10 with LEFT: vehicle gel and RIGHT: aprepitant 10 mg/g gel'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.8', 'spread': '11.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-21', 'studyFirstSubmitDate': '2013-09-18', 'resultsFirstSubmitDate': '2018-08-17', 'studyFirstSubmitQcDate': '2013-10-11', 'lastUpdatePostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-06-28', 'studyFirstPostDateStruct': {'date': '2013-10-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pruritus by VAS (Visual Analogue Scale)', 'timeFrame': 'At end of treatment (Day 28)', 'description': 'At end of treatment (Day 28) participants assessed the intensity of present pruritus of each treated area on a visual analogue scale (VAS) with a score of "0" (no itch at all) to "10" (worst imaginable itch) at the two extremes on a 100 mm line.'}], 'secondaryOutcomes': [{'measure': 'Pruritus by VAS (Visual Analogue Scale)', 'timeFrame': 'At baseline (Day 1), Day 14, end of treatment (Day 28), and Day 42', 'description': 'At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42, participants assessed the intensity of present pruritus of each treated area on a visual analogue scale (VAS) with a score of "0" (no itch at all) to "10" (worst imaginable itch) at the two extremes on a 100 mm line.'}, {'measure': "Change From Baseline in Participants' Global Assessment on Treatment Areas", 'timeFrame': 'At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42', 'description': 'At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42, participants assessed their prurigo on each treated area using the following score: 0 = no symptoms, 1 = mild, 2 = moderate, 3 = severe. The change was calculated as the value at the later time point minus the value at baseline. The change at Day 1 was therefore 0 and negative values represent a decrease in score.'}, {'measure': 'Clinical Score Assessment of Crusting', 'timeFrame': 'At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42', 'description': 'The (sub)investigator assessed the clinical picture at each treated area at baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 using the following score:\n\nCriteria:\n\nCrusts\n\nEvaluation:\n\n0 = not existing\n\n1. = mild\n2. = moderate\n3. = severe\n\nThe score will be an integer on the scale 0-3.'}, {'measure': 'Clinical Score Assessment of Erythema', 'timeFrame': 'At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42', 'description': 'The (sub)investigator will assess the clinical picture at each treated area at baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 using the following score:\n\nCriteria:\n\nErythema\n\nEvaluation:\n\n0 = not existing\n\n1. = mild\n2. = moderate\n3. = severe\n\nThe score will be an integer on the scale 0-3.'}, {'measure': 'Clinical Score Assessment of Scratch Artefacts', 'timeFrame': 'At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42', 'description': 'The (sub)investigator will assess the clinical picture at each treated area at baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 using the following score:\n\nCriteria:\n\nScratch artefacts: Superficial damage to the skin caused by severe scratching.\n\nEvaluation:\n\n0 = not existing\n\n1. = mild\n2. = moderate\n3. = severe\n\nThe score will be an integer on the scale 0-3.'}, {'measure': 'Clinical Score Assessment of Infiltration', 'timeFrame': 'At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42', 'description': 'The (sub)investigator will assess the clinical picture at each treated area at baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 using the following score:\n\nCriteria:\n\nInfiltration\n\nEvaluation:\n\n0 = not existing\n\n1. = mild\n2. = moderate\n3. = severe\n\nThe score will be an integer on the scale 0-3.'}, {'measure': 'Transepidermal Water Loss (TEWL)', 'timeFrame': 'At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42', 'description': 'The (sub)investigator will made the following clinical assessment:\n\nTransepidermal water loss was defined as amount of released water from skin surface in g/cm\\^2 per hour. The TEWL is increased in case of damage of skin barrier.'}, {'measure': 'Lesional Erythema by Mexameter', 'timeFrame': 'At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42', 'description': 'The skin colour of the participants was evaluated by use of a Mexameter spectrophotometer. The instrument computed an erythema index (with a range between 0 and 999, where higher values indicate more erythema or redness) which may be used as an indication of skin properties.\n\nMexameter measurements were performed at baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 to assess stimulation of microcirculation, irritating effects, and occurring erythema.'}, {'measure': 'Non-lesional Erythema by Mexameter', 'timeFrame': 'At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42', 'description': 'The skin colour of the participants was evaluated by use of a Mexameter spectrophotometer. The instrument computed an erythema index (with a range between 0 and 999, where higher values indicate more erythema or redness) which may be used as an indication of skin properties.\n\nMexameter measurements were performed at baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 to assess stimulation of microcirculation, irritating effects, and occurring erythema.'}, {'measure': 'Melanin by Mexameter', 'timeFrame': 'At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42', 'description': 'The skin colour of the participants was evaluated by use of a Mexameter spectrophotometer. The instrument computed a melanin index (with a range between 0 and 999, where higher values indicate more melanin) which may be used as an indication of skin properties.\n\nMexameter measurements were performed at baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 to assess stimulation of microcirculation, irritating effects, and occurring erythema.'}, {'measure': 'Non-lesional Melanin by Mexameter', 'timeFrame': 'At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42', 'description': 'The skin colour of the participants was evaluated by use of a Mexameter spectrophotometer. The instrument computed a melanin index (with a range between 0 and 999, where higher values indicate more melanin) which may be used as an indication of skin properties.\n\nMexameter measurements were performed at baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 to assess stimulation of microcirculation, irritating effects, and occurring erythema.'}, {'measure': 'Daily Assessments of Duration of Pruritus (Preceding 12 Hours)', 'timeFrame': 'From baseline to Day 31', 'description': 'During the trial participants completed a diary twice daily, in the morning and in the evening, each covering the preceding 12 hours, which collected the number of hours with pruritus within the last 12 hours on both areas by use of a 7-point scale (\\<0.5 hours, 0.5-1 hours, 1-2 hours, 3-4 hours, 5-6 hours, 7-8 hours, 9-12 hours).\n\nDuration of pruritus was categorized as follows: 1 if \\<0.5 hours, 2 if 0.5-1 hours, 3 if 1-2 hours, 4 if 3-4 hours, 5 if 5-6 hours, 6 if 7-8 hours and 7 if 9-12 hours.\n\nThe evening baseline measure was taken on the evening of Day -1 and the morning baseline measure was taken on the morning of Day 1 before cream was applied.'}, {'measure': 'Daily Assessments of Average Pruritus by Use of a VAS', 'timeFrame': 'From baseline to Day 31', 'description': 'During the trial participants completed a diary twice daily, in the morning and in the evening, each covering the preceding 12 hours, which collected the average intensity of pruritus since last evaluation by use of a VAS (ranging from 0 to 100). The participants assessed the intensity of present pruritus of each treated area on a visual analogue scale (VAS) with a score of "0" (no itch at all) to "10" (worst imaginable itch) at the two extremes on a 100 mm line.\n\nThe evening baseline measure was taken on the evening of Day -1 and the morning baseline measure was taken on the morning of Day 1, before cream was applied.'}, {'measure': 'Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS', 'timeFrame': 'From baseline to Day 31', 'description': 'During the trial participants completed a diary twice daily, in the morning and in the evening, each covering the preceding 12 hours, which collected the maximum intensity of pruritus since last evaluation by use of a VAS (ranging from 0 to 100). The participants assessed the intensity of present pruritus of each treated area on a visual analogue scale (VAS) with a score of "0" (no itch at all) to "10" (worst imaginable itch) at the two extremes on a 100 mm line.\n\nThe evening baseline measure was taken on the evening of Day -1 and the morning baseline measure was taken on the morning of Day 1 before cream was applied.'}, {'measure': 'Percent Change From Baseline in Pruritis Assessed by VAS at End of Treatment', 'timeFrame': 'Day 28', 'description': 'On the last day of treatment, participants assessed the change of pruritus compared to baseline in percentage by use of a VAS (ranging from 0 to 100). The participants assessed the intensity of present pruritus of each treated area on a visual analogue scale (VAS) with a score of "0" (no itch at all) to "10" (worst imaginable itch) at the two extremes on a 100 mm line.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pruritus'], 'conditions': ['Pruritus']}, 'descriptionModule': {'briefSummary': 'Topical Aprepitant in Prurigo Patients - An Exploratory Phase IIa Trial With Topically Applied Aprepitant in Patients With Prurigo'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with Prurigo suffering from chronic pruritus\n* Disease duration \\> six month\n* Therapy refractory to at least two previous antipruritic treatments with topical, intralesional or systemic corticosteroids, or other immunosuppressants, antihistamines, antipsychotics, antidepressants, anticonvulsants and/or UV-irradiation\n* Adult male or female patients, aged 18 to 80 years\n\nExclusion Criteria:\n\n* Concomitant medications that are primarily metabolized through Cytochrome P450 3A4\n* Applied topical antihistamines, corticosteroids or mast cell stabilizers to the skin less than 3 weeks prior to Visit 1 (Screening) or during the course of the trial\n* UV-irradiation during the last 6 weeks prior to Visit 1 (Screening)\n* Prescribed systemic medications are limited\n* Clinically significant abnormalities in Blood analyses\n* Anamnestic excessive use of alcohol or tobacco or drugs\n* Presence of active tumor disease or history of malignancies within five years prior to Visit 1 (Screening)\n* Known or suspected hypersensitivity to component(s) of investigational products\n* Within the last 30 days or current participation in any other interventional clinical trial\n* Subjects who have received treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registration) within the last 6 month\n* Previously enrolled/randomised in this clinical trial\n* In the opinion of the investigator, the subject is unlikely to comply with the Clinical Study Protocol (e.g., alcoholism, drug dependency or psychotic state)\n* Females who are pregnant, of child-bearing potential and wishing to become pregnant during the trial or are breast feeding\n* Females of child-bearing potential with positive pregnancy test\n* Subjects (or their partner) not using an adequate method of contraception (according to national requirements, as applicable)'}, 'identificationModule': {'nctId': 'NCT01963793', 'acronym': 'iTAPP', 'briefTitle': 'Topical Aprepitant in Prurigo Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'LEO Pharma'}, 'officialTitle': 'Topical Aprepitant in Prurigo Patients An Exploratory Phase IIa Trial With Topically Applied Aprepitant in Patients With Prurigo', 'orgStudyIdInfo': {'id': 'LP0066-1019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'placebo (left) / aprepitant (right)', 'description': 'placebo (on defined treatment area on left side of the body) / aprepitant (on defined treatment area on right side of the body)', 'interventionNames': ['Drug: Aprepitant', 'Drug: Placebo']}, {'type': 'OTHER', 'label': 'aprepitant (left) / placebo (right)', 'description': 'aprepitant (on a treatment area on the left side of the body) / placebo (on a treatment area on the right side of the body)', 'interventionNames': ['Drug: Aprepitant', 'Drug: Placebo']}], 'interventions': [{'name': 'Aprepitant', 'type': 'DRUG', 'otherNames': ['Aprepitant gel'], 'description': 'Aprepitant gel (10 mg/g)', 'armGroupLabels': ['aprepitant (left) / placebo (right)', 'placebo (left) / aprepitant (right)']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['aprepitant gel vehicle'], 'description': 'gel without active component', 'armGroupLabels': ['aprepitant (left) / placebo (right)', 'placebo (left) / aprepitant (right)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Allergie-Zentrum-Charité, Charité - Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Maurer (ICI) Marcus, Prof. Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Allergie-Centrum-Charité, Charité Universitätsmedizin Berlin, Charitéplatz1, D-10117 Berlin'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LEO Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}