Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2025-12-26 @ 1:54 AM
Study NCT ID:
NCT04856904
Status:
COMPLETED
Last Update Posted:
2024-06-11
First Post:
2021-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Trifarotene Cream to Assess Risk of a Trophic Acne Scar Formation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000152', 'term': 'Acne Vulgaris'}], 'ancestors': [{'id': 'D017486', 'term': 'Acneiform Eruptions'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012625', 'term': 'Sebaceous Gland Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000629420', 'term': 'trifarotene'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'reception.seupp@galderma.com', 'phone': '+46184749000', 'title': 'Clinical Scientist', 'organization': 'Galderma R&D, Inc.'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From screening up to Week 28', 'description': 'The safety (SAF) population included the ITT population participants who applied the study drug at least once.', 'eventGroups': [{'id': 'EG000', 'title': 'Trifarotene 50mcg/g Cream', 'description': 'Participants applied a thin layer of trifarotene cream to half of their face topically once daily for up to 24 weeks.', 'otherNumAtRisk': 121, 'deathsNumAtRisk': 121, 'otherNumAffected': 7, 'seriousNumAtRisk': 121, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Trifarotene Vehicle Cream', 'description': 'Participants applied a thin layer of trifarotene vehicle cream to another half of their face topically once daily for up to 24 weeks.', 'otherNumAtRisk': 121, 'deathsNumAtRisk': 121, 'otherNumAffected': 3, 'seriousNumAtRisk': 121, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'All Acne Vulgaris Participants', 'description': 'All participants applied a thin layer of trifarotene 50 mcg/g cream to half of their face and trifarotene vehicle cream to another half of their face topically once daily for up to 24 weeks.', 'otherNumAtRisk': 121, 'deathsNumAtRisk': 121, 'otherNumAffected': 33, 'seriousNumAtRisk': 121, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Kidney infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Skin tightness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Skin irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Food poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Hyperaesthesia teeth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Accidental exposure to product', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Hand fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Adverse reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Face oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Vaccination site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Burning sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'SARS-CoV-2 test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Food allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Absolute Change From Baseline in Total Atrophic Acne Scar Count Per Half Face at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trifarotene 50mcg/g Cream', 'description': 'Participants applied a thin layer of trifarotene cream to half of their face topically once daily for up to 24 weeks.'}, {'id': 'OG001', 'title': 'Trifarotene Vehicle Cream', 'description': 'Participants applied a thin layer of trifarotene vehicle cream to another half of their face topically once daily for up to 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.9', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '-2.7', 'spread': '0.37', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Bilateral difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.2', 'ciLowerLimit': '-4.4', 'ciUpperLimit': '-2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.6', 'statisticalMethod': "Student's t-test for paired samples", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'The scars were counted according to their size defined in two categories using 2 millimeter (mm) and 4 mm punch biopsy tools for size classification: 1) atrophic scars 2 to 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types; 2) atrophic scars greater than (\\>) 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types. Each type of atrophic acne scar was counted separately for each half-face by the evaluator for following regions: right forehead, right cheek, right side of the chin, left forehead, left cheek and left side of the chin. To obtain the total number of atrophic scars per half-face, atrophic acne scar counts for each half-face was added.', 'unitOfMeasure': 'atrophic acne scars', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Total Atrophic Acne Scar Count Per Half-Face up to Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trifarotene 50mcg/g Cream', 'description': 'Participants applied a thin layer of trifarotene cream to half of their face topically once daily for up to 24 weeks.'}, {'id': 'OG001', 'title': 'Trifarotene Vehicle Cream', 'description': 'Participants applied a thin layer of trifarotene vehicle cream to another half of their face topically once daily for up to 24 weeks.'}], 'classes': [{'title': 'Change at Week 1', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.16', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.11', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4', 'categories': [{'measurements': [{'value': '-1.5', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '0.18', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8', 'categories': [{'measurements': [{'value': '-2.5', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '0.30', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12', 'categories': [{'measurements': [{'value': '-3.8', 'spread': '0.37', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '0.32', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 16', 'categories': [{'measurements': [{'value': '-4.4', 'spread': '0.40', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '0.47', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 20', 'categories': [{'measurements': [{'value': '-5.0', 'spread': '0.47', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '0.33', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '= 0.9476', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Bilateral difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.14', 'groupDescription': 'Week 1: Trifarotene 50 mcg/g, vehicle cream', 'statisticalMethod': "Student's t-test for paired samples", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.0248', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Bilateral difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '-0.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.25', 'groupDescription': 'Week 2: Trifarotene 50 mcg/g, vehicle cream', 'statisticalMethod': "Student's t-test for paired samples", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.0072', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Bilateral difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '-0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.29', 'groupDescription': 'Week 4: Trifarotene 50 mcg/g, vehicle cream', 'statisticalMethod': "Student's t-test for paired samples", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Bilateral difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.4', 'ciLowerLimit': '-2.1', 'ciUpperLimit': '-0.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.35', 'groupDescription': 'Week 8: Trifarotene 50 mcg/g, vehicle cream', 'statisticalMethod': "Student's t-test for paired samples", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Bilateral difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.1', 'ciLowerLimit': '-2.9', 'ciUpperLimit': '-1.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.41', 'groupDescription': 'Week 12: Trifarotene 50 mcg/g, vehicle cream', 'statisticalMethod': "Student's t-test for paired samples", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Bilateral difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.7', 'ciLowerLimit': '-3.8', 'ciUpperLimit': '-1.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.56', 'groupDescription': 'Week 16: Trifarotene 50 mcg/g, vehicle cream', 'statisticalMethod': "Student's t-test for paired samples", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Bilateral difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.5', 'ciLowerLimit': '-3.5', 'ciUpperLimit': '-1.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.53', 'groupDescription': 'Week 20: Trifarotene 50 mcg/g, vehicle cream', 'statisticalMethod': "Student's t-test for paired samples", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, up to Week 20', 'description': 'The scars were counted according to their size defined in two categories using 2 mm and 4 mm punch biopsy tools for size classification: 1) atrophic scars 2 to 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types; 2) atrophic scars \\> 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types. Each type of atrophic acne scar was counted separately for each half-face by the evaluator for following regions: right forehead, right cheek, right side of the chin, left forehead, left cheek and left side of the chin. To obtain the total number of atrophic scars per half-face, atrophic acne scar counts for each half-face was added.', 'unitOfMeasure': 'atrophic acne scars', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Trifarotene 50mcg/g Cream', 'description': 'Participants applied a thin layer of trifarotene cream to half of their face topically once daily for up to 24 weeks.'}, {'id': 'FG001', 'title': 'Trifarotene Vehicle Cream', 'description': 'Participants applied a thin layer of trifarotene vehicle cream to another half of their face topically once daily for up to 24 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '121', 'numSubjects': '121'}, {'groupId': 'FG001', 'numUnits': '121', 'numSubjects': '121'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '99', 'numSubjects': '99'}, {'groupId': 'FG001', 'numUnits': '99', 'numSubjects': '99'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '22', 'numSubjects': '22'}, {'groupId': 'FG001', 'numUnits': '22', 'numSubjects': '22'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Non-compliance with study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'typeUnitsAnalyzed': 'half faces', 'recruitmentDetails': 'The study was conducted at 20 sites in the United States, Canada, and France.', 'preAssignmentDetails': 'A total 121 participants were enrolled in this study. All participants were randomized (left face versus right face) to apply trifarotene cream and trifarotene vehicle cream for an intra-individual, split-face comparison.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Acne Vulgaris Participants', 'description': 'All participants applied a thin layer of trifarotene 50 mcg/g cream to half of their face and trifarotene vehicle cream to another half of their face topically once daily for up to 24 weeks.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '22.9', 'spread': '5.12', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '88', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '95', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '97', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '110', 'groupId': 'BG000'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'count of participants'}, {'title': 'Fitzpatrick Skin Type', 'classes': [{'title': 'Type I', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': 'Type II', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}]}]}, {'title': 'Type III', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}]}]}, {'title': 'Type IV', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}, {'title': 'Type V', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}, {'title': 'Type VI', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Skin Type I = White; very fair, red or blonde hair blue eyes; freckles; Always burns, never tans Skin Type II = White, fair, red or blond hair; blue, hazel or green eyes; Usually burns, tans with difficulty Skin Type III = Cream white; fair with any eye or hair color (common); Sometimes mild burn, gradually tans Skin Type IV = Brown; typical Mediterranean Caucasian skin; Rarely burns, tans with ease Skin Type V = Dark Brown; mid-eastern skin types; Very rarely burns, tans easily Skin Type VI = Black; Never burns, tans very easily', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent to treat (ITT) population included all randomized partcipants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-07-28', 'size': 5051020, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-03-07T08:58', 'hasProtocol': True}, {'date': '2023-02-27', 'size': 6972880, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-03-07T08:57', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 121}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-10', 'studyFirstSubmitDate': '2021-04-20', 'resultsFirstSubmitDate': '2024-03-15', 'studyFirstSubmitQcDate': '2021-04-20', 'lastUpdatePostDateStruct': {'date': '2024-06-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-06-10', 'studyFirstPostDateStruct': {'date': '2021-04-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absolute Change From Baseline in Total Atrophic Acne Scar Count Per Half Face at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'The scars were counted according to their size defined in two categories using 2 millimeter (mm) and 4 mm punch biopsy tools for size classification: 1) atrophic scars 2 to 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types; 2) atrophic scars greater than (\\>) 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types. Each type of atrophic acne scar was counted separately for each half-face by the evaluator for following regions: right forehead, right cheek, right side of the chin, left forehead, left cheek and left side of the chin. To obtain the total number of atrophic scars per half-face, atrophic acne scar counts for each half-face was added.'}], 'secondaryOutcomes': [{'measure': 'Absolute Change From Baseline in Total Atrophic Acne Scar Count Per Half-Face up to Week 20', 'timeFrame': 'Baseline, up to Week 20', 'description': 'The scars were counted according to their size defined in two categories using 2 mm and 4 mm punch biopsy tools for size classification: 1) atrophic scars 2 to 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types; 2) atrophic scars \\> 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types. Each type of atrophic acne scar was counted separately for each half-face by the evaluator for following regions: right forehead, right cheek, right side of the chin, left forehead, left cheek and left side of the chin. To obtain the total number of atrophic scars per half-face, atrophic acne scar counts for each half-face was added.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acne vulgaris', 'Trifarotene', 'AKLIEF®', 'CD5789'], 'conditions': ['Acne Vulgaris']}, 'referencesModule': {'references': [{'pmid': '37838987', 'type': 'DERIVED', 'citation': 'Schleicher S, Moore A, Rafal E, Gagne-Henley A, Johnson SM, Dhawan S, Chavda R, York JP, Sforzolini B, Holcomb K, Ablon G, Del Rosso J, Dreno B. Trifarotene Reduces Risk for Atrophic Acne Scars: Results from A Phase 4 Controlled Study. Dermatol Ther (Heidelb). 2023 Dec;13(12):3085-3096. doi: 10.1007/s13555-023-01042-7. Epub 2023 Oct 15.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of trifarotene 50 microgram per gram (mcg/g) cream compared to its vehicle on the risk of formation of atrophic acne scars after 24 weeks of treatment in facial acne participants assessed by atrophic acne scars count.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '35 Years', 'minimumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Participant with clinical diagnosis of acne vulgaris on the face as defined by (excluding the nose and middle zone of approximately 2 centimeter \\[cm\\]):\n\n 1. Investigator's Global Assessment (IGA) score of 3 (Moderate) or 4 (Severe), with the same score on both sides of the face; and\n 2. A minimum of 20 inflammatory lesions (papules and pustules) in total with at least 10 on each side; and\n 3. No more than 2 nodules (greater than or equal to \\[\\>=\\] 1 cm in diameter) on the face; and\n 4. A minimum of 10 atrophic acne scars in total (\\>2 mm)\n* Participant with a symmetrical number of the following lesions/scars on the whole face:\n\n 1. Inflammatory and non-inflammatory lesions; and\n 2. Atrophic acne scars (minimum of 4 scars per half-face)\n* The participant is a female of non-childbearing potential\n* If a female of childbearing, potential uses oral contraceptives that are also approve for treating acne vulgaris\n* Other protocol defined inclusion criteria could apply\n\nKey Exclusion Criteria:\n\n* Participant with acne conglobata, acne fulminans, secondary acne, nodulocystic acne and acne requiring systemic treatment\n* Participant with any acne cyst on the face or with more than 3 excoriated acne lesions\n* Participant with known active or chronic allergies or suspected allergy to trifarotene or excipients of the formulation\n* Participant with facial dermal conditions (for example, tattoo, skin abrasion, eczema, sunburned skin, scars, nevi, etc.) that may interfere with study assessments in the opinion of the investigator\n* Participant with known impaired hepatic or renal functions, based on medical history"}, 'identificationModule': {'nctId': 'NCT04856904', 'acronym': 'START', 'briefTitle': 'Study of Trifarotene Cream to Assess Risk of a Trophic Acne Scar Formation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galderma R&D'}, 'officialTitle': 'Evaluation of the Risk of Atrophic Acne Scar Formation During Treatment of Acne Vulgaris Subjects With Trifarotene 50 μg/g Cream Versus Vehicle Cream Over 24 Weeks', 'orgStudyIdInfo': {'id': 'RD.06.SPR.202395'}, 'secondaryIdInfos': [{'id': '2020-006050-51', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Trifarotene Vehicle Cream', 'interventionNames': ['Drug: Trifarotene Vehicle Cream']}, {'type': 'EXPERIMENTAL', 'label': 'Trifarotene (CD5789) 50 mcg/g Cream', 'interventionNames': ['Drug: Trifarotene Cream']}], 'interventions': [{'name': 'Trifarotene Cream', 'type': 'DRUG', 'otherNames': ['AKLIEF®'], 'description': 'Participants will apply a thin a layer of trifarotene (CD5789) 50 mcg/g cream to the face once daily, in the evening for 24 weeks', 'armGroupLabels': ['Trifarotene (CD5789) 50 mcg/g Cream']}, {'name': 'Trifarotene Vehicle Cream', 'type': 'DRUG', 'description': 'Participants will apply a thin a layer of trifarotene vehicle cream to the face once daily, in the evening for 24 weeks', 'armGroupLabels': ['Trifarotene Vehicle Cream']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85260', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Galderma Investigational Site #8873', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '72916', 'city': 'Fort Smith', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Galderma Investigational Site #8447', 'geoPoint': {'lat': 35.38592, 'lon': -94.39855}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Galderma Investigational Site #8608', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '33437', 'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Galderma Investigational Site #9928', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Galderma Investigational Site #8295', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33027', 'city': 'Miramar', 'state': 'Florida', 'country': 'United States', 'facility': 'Galderma Investigational Site #8883', 'geoPoint': {'lat': 25.98731, 'lon': -80.23227}}, {'zip': '30078', 'city': 'Snellville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Galderma Investigational Site #8189', 'geoPoint': {'lat': 33.85733, 'lon': -84.01991}}, {'zip': '60005', 'city': 'Arlington Heights', 'state': 'Illinois', 'country': 'United States', 'facility': 'Galderma Investigational Site #8367', 'geoPoint': {'lat': 42.08836, 'lon': -87.98063}}, {'zip': '60561', 'city': 'Darien', 'state': 'Illinois', 'country': 'United States', 'facility': 'Galderma Investigational Site #8838', 'geoPoint': {'lat': 41.75198, 'lon': -87.97395}}, {'zip': '70001', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Galderma Investigational Site #8601', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '70130', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Galderma Investigational Site #9936', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '89148', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Galderma Investigational Site #8108', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '11790', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'Galderma Investigational Site #8881', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '18249', 'city': 'Sugarloaf', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Galderma Investigational Site #8886', 'geoPoint': {'lat': 41.98343, 'lon': -76.12083}}, {'zip': '76011', 'city': 'Arlington', 'state': 'Texas', 'country': 'United States', 'facility': 'Galderma Investigational Site #9920', 'geoPoint': {'lat': 32.73569, 'lon': -97.10807}}, {'city': 'Peterborough', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Galderma Investigational Site #9918', 'geoPoint': {'lat': 44.30012, 'lon': -78.31623}}, {'city': 'Saint-Jérôme', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Galderma Investigational Site #9927', 'geoPoint': {'lat': 45.78036, 'lon': -74.00365}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'Galderma Investigational Site #6167', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Galderma R&D', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}