Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-01-10 @ 12:03 AM
Study NCT ID:
NCT06733402
Status:
COMPLETED
Last Update Posted:
2024-12-13
First Post:
2024-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Comparing Trifarotene Cream 0.005% to AKLIEF® CREAM (US REFERENCE LISTED DRUG), AKLIEF™ CREAM (CANADIAN REFERENCE PRODUCT) in the Treatment of Acne Vulgaris
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-11-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-10', 'studyFirstSubmitDate': '2024-12-10', 'studyFirstSubmitQcDate': '2024-12-10', 'lastUpdatePostDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Demonstrate the therapeutic equivalence, efficacy and safety of the Investigational Product', 'timeFrame': 'Baseline to Week 12', 'description': 'Percentage change in the inflammatory (papules and pustules) \\& non-inflammatory (open and closed comedones) of the lesion counts.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acne Vulgaris']}, 'descriptionModule': {'briefSummary': 'To demonstrate the efficacy, therapeutic equivalence and safety of Trifarotene Cream 0.005% (Taro Pharmaceuticals U.S.A., Inc.) and US Reference Listed Drug, Canadian Reference Product over the placebo control in the treatment of acne vulgaris.', 'detailedDescription': 'A multi-center, double-blind, randomized, placebo-controlled, parallel-group study, comparing comparing Trifarotene Cream 0.005% (Taro Pharmaceuticals U.S.A, Inc.) to Aklief® Cream (US REFERENCE LISTED DRUG), Aklief Cream (REFERENCE PRODUCT) and each active treatment to a placebo control in the treatment of acne vulgaris.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy male or non-pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.\n* Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3 or 4 as per the Investigator's Global Assessment (IGA).\n* Subjects must have ≥ 25 non-inflammatory lesions (i.e., open and closed comedones) AND ≥ 20 inflammatory lesions (i.e., papules and pustules) AND ≤2 nodulocystic lesions (i.e., nodules and cysts), at baseline on the face.\n* Subjects must be willing to refrain from using all other topical acne medications or antibiotics for acne vulgaris during the 12-week treatment period, other than the investigational product.\n\nExclusion Criteria:\n\n* Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.\n* Subjects with a history of hypersensitivity or allergy to Trifarotene, retinoids and/or any of the study medication ingredients.\n* Subjects with excessive facial hair (e.g. beards, sideburns, mustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris.\n* Subjects with a baseline irritation score of 3 = severe (marked, intense)."}, 'identificationModule': {'nctId': 'NCT06733402', 'briefTitle': 'A Study Comparing Trifarotene Cream 0.005% to AKLIEF® CREAM (US REFERENCE LISTED DRUG), AKLIEF™ CREAM (CANADIAN REFERENCE PRODUCT) in the Treatment of Acne Vulgaris', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sun Pharmaceutical Industries, Inc.'}, 'officialTitle': 'A Multi-center, Double-blind, Randomized, Placebo Controlled, Parallel-group Study, Comparing Trifarotene Cream 0.005% (Taro Pharmaceuticals U.S.A, Inc.) to Aklief® Cream (US REFERENCE LISTED DRUG), Aklief Cream (REFERENCE PRODUCT) and Each Active Treatment to a Placebo Control in the Treatment of Acne Vulgaris.', 'orgStudyIdInfo': {'id': 'TRFC-2405'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Trifarotene Cream 0.005%', 'description': 'A thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime.', 'interventionNames': ['Drug: Trifarotene Cream 0.005%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'AKLIEF® Cream (Trifarotene 0.005%) US REFERENCE LISTED DRUG', 'description': 'A thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime.', 'interventionNames': ['Drug: AKLIEF® Cream (Trifarotene 0.005%) US REFERENCE LISTED DRUG']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'AKLIEF® Cream (Trifarotene 50 mcg/g) CANADIAN REFERENCE PRODUCT', 'description': 'A thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime.', 'interventionNames': ['Drug: AKLIEF® Cream (Trifarotene 50 mcg/g) CANADIAN REFERENCE PRODUCT']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Control', 'description': 'A thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Trifarotene Cream 0.005%', 'type': 'DRUG', 'otherNames': ['Test Product'], 'description': 'A thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime.', 'armGroupLabels': ['Trifarotene Cream 0.005%']}, {'name': 'AKLIEF® Cream (Trifarotene 0.005%) US REFERENCE LISTED DRUG', 'type': 'DRUG', 'otherNames': ['Reference Product'], 'description': 'A thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime.', 'armGroupLabels': ['AKLIEF® Cream (Trifarotene 0.005%) US REFERENCE LISTED DRUG']}, {'name': 'AKLIEF® Cream (Trifarotene 50 mcg/g) CANADIAN REFERENCE PRODUCT', 'type': 'DRUG', 'otherNames': ['Reference Product'], 'description': 'A thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime.', 'armGroupLabels': ['AKLIEF® Cream (Trifarotene 50 mcg/g) CANADIAN REFERENCE PRODUCT']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Vehicle'], 'description': 'A thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime.', 'armGroupLabels': ['Placebo Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10532', 'city': 'Hawthorne', 'state': 'New York', 'country': 'United States', 'facility': 'Taro Pharmaceuticals USA Inc.', 'geoPoint': {'lat': 41.10732, 'lon': -73.79597}}], 'overallOfficials': [{'name': 'Natalie Yantovskiy', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Taro Pharmaceuticals, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Pharmaceutical Industries, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}