Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-28 @ 12:05 AM
Study NCT ID:
NCT05811234
Status:
COMPLETED
Last Update Posted:
2025-09-24
First Post:
2023-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Assess Treatment Satisfaction, Patient-reported Outcomes, Effectiveness, and Safety of a Fixed-dose Combination of Calcipotriene/Betamethasone Dipropionate PAD Cream in the Treatment of Mild-to-moderate Plaque Psoriasis of the Scalp in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gco@almirall.com', 'phone': '+34932913000', 'title': 'Head of Global Clinical Development', 'organization': 'Almirall S.A'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to end of study observation period (Week 12)', 'eventGroups': [{'id': 'EG000', 'title': 'CAL/BDP PAD Cream', 'description': 'Participants who have been prescribed a fixed dose of Calcipotriene/Betamethasone Dipropionate PAD cream (CAL/BDP PAD cream) treatment to manage plaque psoriasis of the scalp according to summary of product characteristic (SmPC) in routine clinical practice settings were observed for up to 8-12 weeks.', 'otherNumAtRisk': 291, 'deathsNumAtRisk': 291, 'otherNumAffected': 13, 'seriousNumAtRisk': 291, 'deathsNumAffected': 1, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Localised Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Oral Herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Polyarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Urticaria Chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Lung Adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}], 'seriousEvents': [{'term': 'Lung Adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 291, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Absolute Treatment Satisfaction Questionnaire for Medication Version 9 (TSQM-9) Domain Total Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CAL/BDP PAD Cream', 'description': 'Participants who have been prescribed a fixed dose of Calcipotriene/Betamethasone Dipropionate PAD cream (CAL/BDP PAD cream) treatment to manage plaque psoriasis of the scalp according to summary of product characteristic (SmPC) in routine clinical practice settings were observed for up to 8-12 weeks.'}], 'classes': [{'title': 'Effectiveness Total Score: At Week 12', 'categories': [{'measurements': [{'value': '73.56', 'groupId': 'OG000', 'lowerLimit': '70.41', 'upperLimit': '76.71'}]}]}, {'title': 'Convenience Total Score: At Week 12', 'categories': [{'measurements': [{'value': '72.07', 'groupId': 'OG000', 'lowerLimit': '69.65', 'upperLimit': '74.49'}]}]}, {'title': 'Global Satisfaction Total Score: At Week 12', 'categories': [{'measurements': [{'value': '75.97', 'groupId': 'OG000', 'lowerLimit': '73.30', 'upperLimit': '78.65'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At end of study observation period (Week 12)', 'description': 'TSQM-9 was a 9-item clinically validated psychometric instrument developed from the TSQM 1.4. TSQM-9 measures participant satisfaction with the medication in 3 domains: Effectiveness, convenience, and global satisfaction. The scores were computed by adding items for each domain, i.e., 1 to 3 for effectiveness, 4 to 6 for convenience, and 7 to 9 for global satisfaction. The lowest possible score (1 for each item and 3 for all 3 subscales) was subtracted from the composite score and divided by the greatest possible score range. The greatest range was (7-1) x 3 items = 18 for effectiveness and convenience, and (5-1) x 3 items = 12 for global satisfaction. This provided a transformed score between 0 and 1 that was then multiplied by 100. TSQM-9 domain scores range from 0 to 100, with higher scores indicating greater satisfaction for that domain.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all those participants in the safety population that had at least one post-baseline assessment for primary endpoint.'}, {'type': 'SECONDARY', 'title': 'Absolute Scalpdex Questionnaire Domine (Symptoms, Emotions, and Functioning) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CAL/BDP PAD Cream', 'description': 'Participants who have been prescribed a fixed dose of Calcipotriene/Betamethasone Dipropionate PAD cream (CAL/BDP PAD cream) treatment to manage plaque psoriasis of the scalp according to summary of product characteristic (SmPC) in routine clinical practice settings were observed for up to 8-12 weeks.'}], 'classes': [{'title': 'Symptoms: At Week 12', 'categories': [{'measurements': [{'value': '22.66', 'groupId': 'OG000', 'lowerLimit': '20.37', 'upperLimit': '24.95'}]}]}, {'title': 'Emotions: At Week 12', 'categories': [{'measurements': [{'value': '29.53', 'groupId': 'OG000', 'lowerLimit': '27.08', 'upperLimit': '31.99'}]}]}, {'title': 'Functioning: At Week 12', 'categories': [{'measurements': [{'value': '26.88', 'groupId': 'OG000', 'lowerLimit': '24.22', 'upperLimit': '29.53'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At end of study observation period (Week 12)', 'description': 'Scalpdex is a scalp dermatitis-specific quality of life (QoL) instrument that can be used to determine which aspect of the disease most bothers the participant and to evaluate QoL as one variable of responsiveness to the therapeutic intervention. It has 23 items, with possible answers scoring on a 5-point Likert-type scale of 0 to 100 ("never" = 0, "rarely" = 25, "sometimes" = 50, "often" = 75, and "all the time" = 100). The final domine scores (symptoms, emotions, and functioning) are calculated by the mean of the item scores pertaining to each scale is the average of the scores of the 23 items with range of 0 to 100. A lower score on symptoms, emotions, and functioning represents a better related-QoL for each scale.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all those participants in the safety population that had at least one post-baseline assessment for primary endpoint.'}, {'type': 'SECONDARY', 'title': "Percentage of Participants Achieved Scalp Physician's Global Assessment (Scalp-PGA) Treatment Success at Week 4 and 12", 'denoms': [{'units': 'Participants', 'counts': [{'value': '250', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CAL/BDP PAD Cream', 'description': 'Participants who have been prescribed a fixed dose of Calcipotriene/Betamethasone Dipropionate PAD cream (CAL/BDP PAD cream) treatment to manage plaque psoriasis of the scalp according to summary of product characteristic (SmPC) in routine clinical practice settings were observed for up to 8-12 weeks.'}], 'classes': [{'title': 'Scalp-PGA Success at Week 4: Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '48.00', 'groupId': 'OG000'}]}]}, {'title': 'Scalp-PGA Success at Week 4: No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '52.00', 'groupId': 'OG000'}]}]}, {'title': 'Scalp-PGA Success at Week 12: Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '250', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '68.40', 'groupId': 'OG000'}]}]}, {'title': 'Scalp-PGA Success at Week 12: No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '250', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '31.60', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 4 and End of study observation period (Week 12)', 'description': 'Scalp-PGA treatment success was defined as a scalp-PGA score of 0 (clear) or 1 (almost clear) and with a minimum 2 points improvement from baseline, on the scalp.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all those participants in the safety population that had at least one post-baseline assessment for primary endpoint. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies who were evaluable at specific timepoints.'}, {'type': 'SECONDARY', 'title': 'Absolute Scalp Worst Itch Numerical Rating Scale (WI-NRS) Questionnaire Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CAL/BDP PAD Cream', 'description': 'Participants who have been prescribed a fixed dose of Calcipotriene/Betamethasone Dipropionate PAD cream (CAL/BDP PAD cream) treatment to manage plaque psoriasis of the scalp according to summary of product characteristic (SmPC) in routine clinical practice settings were observed for up to 8-12 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '6.43', 'groupId': 'OG000', 'lowerLimit': '6.13', 'upperLimit': '6.73'}]}]}, {'title': 'At Week 12', 'categories': [{'measurements': [{'value': '2.66', 'groupId': 'OG000', 'lowerLimit': '2.34', 'upperLimit': '2.97'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, End of study observation period (Week 12)', 'description': 'WI-NRS is a self-administered scale to assess participants worst level of itching on the scalp (in the last week). The scale has a single-item that describes the worst level of itching on the scalp due to psoriasis in the last week on an 11-point scale anchored at 0 (no itching) and 10 (worst itching imaginable).', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all those participants in the safety population that had at least one post-baseline assessment for primary endpoint.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CAL/BDP PAD Cream', 'description': 'Participants who have been prescribed a fixed dose of Calcipotriene/Betamethasone Dipropionate PAD cream (CAL/BDP PAD cream) treatment to manage plaque psoriasis of the scalp according to summary of product characteristic (SmPC) in routine clinical practice settings were observed for up to 8-12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '291'}]}, {'type': 'Safety Population', 'comment': 'Safety population included all participants for whom it is known that they had at least one CAL/BDP PAD cream application during the study observation period.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '291'}]}, {'type': 'Full Analysis Set (FAS)', 'comment': 'FAS included all those participants in the safety population that had at least one post-baseline assessment\\* for primary endpoint.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '253'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '265'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}], 'dropWithdraws': [{'type': 'Loss of Effectiveness', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'Personal reason, or the patient stops taking the study treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This study was conducted at 33 sites across three European countries (Germany, Spain, and the United Kingdom) from 13 June 2023 to 01 October 2024.', 'preAssignmentDetails': 'A total of 291 participants were enrolled in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'CAL/BDP PAD Cream', 'description': 'Participants who have been prescribed a fixed dose of Calcipotriene/Betamethasone Dipropionate PAD cream (CAL/BDP PAD cream) treatment to manage plaque psoriasis of the scalp according to summary of product characteristic (SmPC) in routine clinical practice settings were observed for up to 8-12 weeks.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '47.88', 'spread': '17.40', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '187', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '104', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino'}, {'title': 'Not Hispanic or Latino'}, {'title': 'Unknown or Not Reported'}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Ethnicity were not collected from any participant.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '265', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety population included all participants for whom it is known that they had at least one CAL/BDP PAD cream application during the study observation period.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-01-09', 'size': 646096, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-08-01T05:03', 'hasProtocol': True}, {'date': '2024-11-07', 'size': 5593729, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-08-01T10:01', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 291}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-04', 'studyFirstSubmitDate': '2023-03-31', 'resultsFirstSubmitDate': '2025-09-04', 'studyFirstSubmitQcDate': '2023-03-31', 'lastUpdatePostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-04', 'studyFirstPostDateStruct': {'date': '2023-04-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absolute Treatment Satisfaction Questionnaire for Medication Version 9 (TSQM-9) Domain Total Score at Week 12', 'timeFrame': 'At end of study observation period (Week 12)', 'description': 'TSQM-9 was a 9-item clinically validated psychometric instrument developed from the TSQM 1.4. TSQM-9 measures participant satisfaction with the medication in 3 domains: Effectiveness, convenience, and global satisfaction. The scores were computed by adding items for each domain, i.e., 1 to 3 for effectiveness, 4 to 6 for convenience, and 7 to 9 for global satisfaction. The lowest possible score (1 for each item and 3 for all 3 subscales) was subtracted from the composite score and divided by the greatest possible score range. The greatest range was (7-1) x 3 items = 18 for effectiveness and convenience, and (5-1) x 3 items = 12 for global satisfaction. This provided a transformed score between 0 and 1 that was then multiplied by 100. TSQM-9 domain scores range from 0 to 100, with higher scores indicating greater satisfaction for that domain.'}], 'secondaryOutcomes': [{'measure': 'Absolute Scalpdex Questionnaire Domine (Symptoms, Emotions, and Functioning) Scores', 'timeFrame': 'At end of study observation period (Week 12)', 'description': 'Scalpdex is a scalp dermatitis-specific quality of life (QoL) instrument that can be used to determine which aspect of the disease most bothers the participant and to evaluate QoL as one variable of responsiveness to the therapeutic intervention. It has 23 items, with possible answers scoring on a 5-point Likert-type scale of 0 to 100 ("never" = 0, "rarely" = 25, "sometimes" = 50, "often" = 75, and "all the time" = 100). The final domine scores (symptoms, emotions, and functioning) are calculated by the mean of the item scores pertaining to each scale is the average of the scores of the 23 items with range of 0 to 100. A lower score on symptoms, emotions, and functioning represents a better related-QoL for each scale.'}, {'measure': "Percentage of Participants Achieved Scalp Physician's Global Assessment (Scalp-PGA) Treatment Success at Week 4 and 12", 'timeFrame': 'At Week 4 and End of study observation period (Week 12)', 'description': 'Scalp-PGA treatment success was defined as a scalp-PGA score of 0 (clear) or 1 (almost clear) and with a minimum 2 points improvement from baseline, on the scalp.'}, {'measure': 'Absolute Scalp Worst Itch Numerical Rating Scale (WI-NRS) Questionnaire Score', 'timeFrame': 'Baseline, End of study observation period (Week 12)', 'description': 'WI-NRS is a self-administered scale to assess participants worst level of itching on the scalp (in the last week). The scale has a single-item that describes the worst level of itching on the scalp due to psoriasis in the last week on an 11-point scale anchored at 0 (no itching) and 10 (worst itching imaginable).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mild-to-moderate plaque psoriasis', 'Prospective', 'Psoriasis', 'PRO-SCALP', 'Plaque psoriasis of the scalp'], 'conditions': ['Plaque Psoriasis']}, 'descriptionModule': {'briefSummary': 'The main aim of this study is to assess treatment satisfaction, quality of life, treatment preference, adherence and convenience, psychosocial effects of scalp psoriasis, sleep quality, and effectiveness, and safety of Calcipotriene/Betamethasone Dipropionate (CAL/BDP) PAD cream in a real-world setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult male and female participants with mild-to-moderate plaque psoriasis of the scalp will be observed in this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult (greater than or equal to \\[\\>=\\] 18 years) male or female participants with mild-to-moderate plaque psoriasis of the scalp (defined as scalp-PGA score of 2 or 3 at baseline) with or without involvement of the trunk and limbs, and who may or may not have been previously treated (treatment-naive participants) with other anti-psoriatic therapies.\n2. Participants who have been prescribed CAL/BDP PAD cream (Wynzora®) treatment to manage plaque psoriasis of the scalp according to SmPC in routine clinical practice.\n3. Willingness and ability to participate in the study; participants must give their written consent to participate.\n\nExclusion Criteria:\n\n1. Participants with severe plaque psoriasis, per physician global assessment.\n2. Participants with erythrodermic, exfoliative or pustular psoriasis.\n3. Participants previously treated with systemic drugs for psoriasis (conventional or biologic) within the last 12 weeks prior to inclusion.\n4. Concomitant systemic treatment with anti-psoriatic drugs.\n5. Concomitant treatment of any type for plaque psoriasis of the scalp.\n6. Hypersensitivity to the active substances or to any of the excipients of CAL/BDP PAD cream (Wynzora®).\n7. Participants with known disorders of calcium metabolism.\n8. Participants with viral (e.g., herpes or varicella) lesions of the skin, fungal or bacterial skin infections, parasitic infections, skin manifestations in relation to tuberculosis, perioral dermatitis, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcers, and wounds.\n9. Pregnant or breastfeeding women, except when the potential benefit justifies the potential risk.\n10. Participants unable to comply with the requirements of the study or who in the opinion of the study physician should not participate in the study.\n11. Participants for whom medical chart is inaccessible to physicians to complete baseline data collection.'}, 'identificationModule': {'nctId': 'NCT05811234', 'acronym': 'PRO-SCALP', 'briefTitle': 'A Study to Assess Treatment Satisfaction, Patient-reported Outcomes, Effectiveness, and Safety of a Fixed-dose Combination of Calcipotriene/Betamethasone Dipropionate PAD Cream in the Treatment of Mild-to-moderate Plaque Psoriasis of the Scalp in Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Almirall, S.A.'}, 'officialTitle': 'An International, Prospective, Observational Cohort Study to Assess Patient Treatment Satisfaction, Patient-reported Outcomes, Effectiveness, and Safety of a Fixed-dose Combination of Calcipotriene/Betamethasone Dipropionate PAD Cream in the Treatment of Mild-to-moderate Plaque Psoriasis of the Scalp in Adults (PRO-SCALP)', 'orgStudyIdInfo': {'id': 'M-22201-41'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CAL/BDP PAD Cream:', 'description': 'Participants who have been prescribed CAL/BDP PAD cream treatment to manage plaque psoriasis of the scalp according to summary of product characteristic (SmPC) in routine clinical practice settings will be observed prospectively for up to 8-12 weeks.', 'interventionNames': ['Drug: CAL/BDP PAD Cream']}], 'interventions': [{'name': 'CAL/BDP PAD Cream', 'type': 'DRUG', 'otherNames': ['Wynzora®'], 'description': 'As provided in real-world clinical practice.', 'armGroupLabels': ['CAL/BDP PAD Cream:']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ahaus', 'country': 'Germany', 'facility': 'DE12', 'geoPoint': {'lat': 52.07936, 'lon': 7.01344}}, {'city': 'Augsburg', 'country': 'Germany', 'facility': 'DE07', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'city': 'Cologne', 'country': 'Germany', 'facility': 'DE06', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'city': 'Freising', 'country': 'Germany', 'facility': 'DE08', 'geoPoint': {'lat': 48.40351, 'lon': 11.74876}}, {'city': 'Mainz', 'country': 'Germany', 'facility': 'DE10', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'city': 'Mannheim', 'country': 'Germany', 'facility': 'DE01', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'city': 'Mölln', 'country': 'Germany', 'facility': 'DE05', 'geoPoint': {'lat': 53.62072, 'lon': 10.68748}}, {'city': 'Mönchengladbach', 'country': 'Germany', 'facility': 'DE03', 'geoPoint': {'lat': 51.18539, 'lon': 6.44172}}, {'city': 'Pforzheim', 'country': 'Germany', 'facility': 'DE04', 'geoPoint': {'lat': 48.88436, 'lon': 8.69892}}, {'city': 'Potsdam', 'country': 'Germany', 'facility': 'DE02', 'geoPoint': {'lat': 52.39886, 'lon': 13.06566}}, {'city': 'Remscheid', 'country': 'Germany', 'facility': 'DE11', 'geoPoint': {'lat': 51.17983, 'lon': 7.1925}}, {'city': 'Alcorcón', 'country': 'Spain', 'facility': 'ES04', 'geoPoint': {'lat': 40.34582, 'lon': -3.82487}}, {'city': 'Badalona', 'country': 'Spain', 'facility': 'ES10', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'ES02', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'ES06', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'ES09', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Bilbao', 'country': 'Spain', 'facility': 'ES05', 'geoPoint': {'lat': 43.26271, 'lon': -2.92528}}, {'city': 'Granollers', 'country': 'Spain', 'facility': 'ES03', 'geoPoint': {'lat': 41.60797, 'lon': 2.28773}}, {'city': 'Lleida', 'country': 'Spain', 'facility': 'ES07', 'geoPoint': {'lat': 41.61674, 'lon': 0.62218}}, {'city': 'Pontevedra', 'country': 'Spain', 'facility': 'ES08', 'geoPoint': {'lat': 42.431, 'lon': -8.64435}}, {'city': 'Salamanca', 'country': 'Spain', 'facility': 'ES12', 'geoPoint': {'lat': 40.42972, 'lon': -3.67975}}, {'city': 'Seville', 'country': 'Spain', 'facility': 'ES11', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'city': 'Seville', 'country': 'Spain', 'facility': 'ES13', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'city': 'Zaragoza', 'country': 'Spain', 'facility': 'ES01', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}, {'city': 'Blackburn', 'country': 'United Kingdom', 'facility': 'UK10', 'geoPoint': {'lat': 53.75, 'lon': -2.48333}}, {'city': 'Chertsey', 'country': 'United Kingdom', 'facility': 'UK02', 'geoPoint': {'lat': 51.38812, 'lon': -0.50782}}, {'city': 'Chipping Norton', 'country': 'United Kingdom', 'facility': 'UK06', 'geoPoint': {'lat': 51.94109, 'lon': -1.5453}}, {'city': 'Cockermouth', 'country': 'United Kingdom', 'facility': 'UK08', 'geoPoint': {'lat': 54.66209, 'lon': -3.36086}}, {'city': 'Crewe', 'country': 'United Kingdom', 'facility': 'UK03', 'geoPoint': {'lat': 53.09787, 'lon': -2.44161}}, {'city': 'Exeter', 'country': 'United Kingdom', 'facility': 'UK07', 'geoPoint': {'lat': 50.7236, 'lon': -3.52751}}, {'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'UK14', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'city': 'Kirkcaldy', 'country': 'United Kingdom', 'facility': 'UK15', 'geoPoint': {'lat': 56.11683, 'lon': -3.15999}}, {'city': 'Leicester', 'country': 'United Kingdom', 'facility': 'UK11', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'UK01', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Saint Neots', 'country': 'United Kingdom', 'facility': 'UK05', 'geoPoint': {'lat': 52.21667, 'lon': -0.26667}}, {'city': 'Salisbury', 'country': 'United Kingdom', 'facility': 'UK04', 'geoPoint': {'lat': 51.06931, 'lon': -1.79569}}, {'city': 'Wellingborough', 'country': 'United Kingdom', 'facility': 'UK12', 'geoPoint': {'lat': 52.30273, 'lon': -0.69446}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Almirall, S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}