Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2025-12-25 @ 4:06 PM
Study NCT ID:
NCT03880357
Status:
COMPLETED
Last Update Posted:
2019-03-19
First Post:
2019-03-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
To Evaluate the Therapeutic Equivalence and Safety in Treatment of Scalp Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C517164', 'term': 'betamethasone dipropionate, calcipotriol drug combination'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 485}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-15', 'studyFirstSubmitDate': '2019-03-15', 'studyFirstSubmitQcDate': '2019-03-15', 'lastUpdatePostDateStruct': {'date': '2019-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "treatment success on the Physician's Global Assessment (PGA) of disease severity", 'timeFrame': 'Study Week 4 (Day 28 ± 4 days)', 'description': 'The proportion of subjects in each treatment group with "treatment success" (defined as none or minimal, a score of 0 or 1, within the treatment area) on the PGA of disease severity'}, {'measure': "clinical success on the Physician's Global Assessment (PASI) of disease severity", 'timeFrame': 'Study Week 4 (Day 28 ± 4 days)', 'description': 'The proportion of subjects in each treatment group with "clinical success" (defined as clear or almost clear, a score of 0 or 1, at the target lesion site) on the PASI. Each psoriatic sign of scaling, erythema and plaque elevation should have a score of 0 or 1 for the subject to be considered a clinical success. The target lesion is to be identified at Baseline as the most severe lesion.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Scalp Psoriasis']}, 'descriptionModule': {'briefSummary': 'To demonstrate the superiority of the efficacy of the test and reference products over that of the placebo control in the treatment of scalp psoriasis.', 'detailedDescription': 'Multi-center, double-blind, randomized, placebo controlled, parallel-group study comparing test and reference products to a placebo control in the treatment of scalp psoriasis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male or non-pregnant female aged ≥18 years\n* All male subjects had to agree to use accepted methods of birth control with their partners, from the day of the first application of the study drug to 30 days after the last application of the study drug\n* Willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits\n* A clinical diagnosis of stable (at least 6 months) scalp psoriasis involving at least 10% of the scalp\n\nExclusion Criteria:\n\n* Female subjects who were pregnant, nursing, or planning to become pregnant during study participation\n* Known hypersensitivity to calcipotriene, betamethasone dipropionate, other corticosteroids, or to any ingredients in the study drugs\n* Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative, or pustular psoriasis'}, 'identificationModule': {'nctId': 'NCT03880357', 'briefTitle': 'To Evaluate the Therapeutic Equivalence and Safety in Treatment of Scalp Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sun Pharmaceutical Industries, Inc.'}, 'officialTitle': 'Multi-center, Double-blind, Randomized, Placebo Controlled, Parallel-group Study Comparing Taro Product to RLD and Both Active Treatments to a Placebo Control in the Treatment of Scalp Psoriasis', 'orgStudyIdInfo': {'id': 'BTCS 1614'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test Product', 'description': 'Betamethasone Scalp Suspension 0.064%;0.0005% (Taro Pharmaceuticals Inc.)', 'interventionNames': ['Drug: Betamethasone Scalp Suspension 0.064%;0.0005%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Reference Product', 'description': 'Taclonex® (Calcipotriene Hydrate and Betamethasone Dipropionate) Topical suspension 0.005%/0.064% (LEO PHARMA)', 'interventionNames': ['Drug: Taclonex®']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Vehicle of the test product (Taro Pharmaceuticals Inc.)', 'interventionNames': ['Drug: Placebo topical suspension']}], 'interventions': [{'name': 'Betamethasone Scalp Suspension 0.064%;0.0005%', 'type': 'DRUG', 'otherNames': ['Taclonex'], 'description': 'applied once daily by gently rubbing to the affected area(s) of the scalp for approximately 4 weeks.', 'armGroupLabels': ['Test Product']}, {'name': 'Taclonex®', 'type': 'DRUG', 'otherNames': ['Calcipotriene and Betamethasone Dipropionate'], 'description': 'applied once daily by gently rubbing to the affected area(s) of the scalp for approximately 4 weeks.', 'armGroupLabels': ['Reference Product']}, {'name': 'Placebo topical suspension', 'type': 'DRUG', 'otherNames': ['Vehicle'], 'description': 'applied once daily by gently rubbing to the affected area(s) of the scalp for approximately 4 weeks.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28217', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Catawba Research, LLC', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}], 'overallOfficials': [{'name': 'Natalie Yantovskiy', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Taro Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Pharmaceutical Industries, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}