Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:53 AM
Study NCT ID:
NCT07457294
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-09
First Post:
2026-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
1% Clascoterone Cream for the Treatment Acne Vulgaris
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 692}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-05-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2029-02-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-03', 'studyFirstSubmitDate': '2026-02-26', 'studyFirstSubmitQcDate': '2026-03-03', 'lastUpdatePostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-08-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'P1: Proportion of participants achieving "success" at Week 12 ("success" is defined as an Investigator\'s Global Assessment (IGA) score of 0 or 1, with at least a 2-point reduction from baseline);', 'timeFrame': 'Week 12'}], 'secondaryOutcomes': [{'measure': 'Proportion of participants achieving "success" at Week 4 and Week 8', 'timeFrame': 'Week 4 and Week 8'}, {'measure': 'Absolute change from baseline in NILC at Week 4 and Week 8', 'timeFrame': 'Week 4 and Week 8'}, {'measure': 'Absolute change from baseline in ILC at Week 4 and Week 8', 'timeFrame': 'Week 4 and Week 8'}, {'measure': 'Absolute change from baseline in total lesion count (inflammatory and non-inflammatory lesions) at Week 4, Week 8, and Week 12', 'timeFrame': 'Week 4, Week 8, and Week 12'}, {'measure': 'Percent change from baseline in total lesion count at Week 4, Week 8, and Week 12', 'timeFrame': 'Week 4, Week 8, and Week 12'}, {'measure': 'Percent change from baseline in ILC at Week 4, Week 8, and Week 12', 'timeFrame': 'Week 4, Week 8, and Week 12'}, {'measure': 'Percent change from baseline in NILC at Week 4, Week 8, and Week 12', 'timeFrame': 'Week 4, Week 8, and Week 12'}, {'measure': 'Safety: Incidence of adverse events', 'timeFrame': 'Week 12'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acne Vulgaris']}, 'descriptionModule': {'briefSummary': 'This is a multicenter, randomized, double-blind, parallel, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of 1% Clascoterone Cream in the treatment of acne vulgaris.\n\nTarget population: Participants aged ≥12 years with moderate to severe acne vulgaris who meet the inclusion criteria and none of the exclusion criteria.\n\nTreatment: The investigational group will receive 1% Clascoterone Cream, and the control group will receive placebo. Approximately 1 g of the cream will be applied evenly to the entire face twice daily (morning and evening) for 12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants who are able to understand and comply with the protocol, voluntarily participate in the study, and sign the written informed consent form (ICF); for a participant aged \\<18 years, the written ICF must be co-signed by the minor participant and a parent or legal guardian based on informed consent;\n* Age ≥12 years at the time of ICF signing, regardless of gender;\n* Diagnosis of moderate to severe acne vulgaris (including the nose) at screening and randomization, with an IGA score of 3 or 4, and facial lesions meeting the following criteria: 30-75 inflammatory lesions (papules, pustules, and nodules) and 30-100 non-inflammatory lesions (open and closed comedones);\n* Participants have used the same brand and type of skin and hair care products for at least 2 weeks prior to randomization and agree to continue the current products and regimen during the study period;\n* Female participants of childbearing potential (and their male partners) and male participants (and their female partners) must use highly effective contraception throughout the study period and for at least 3 months after the last dose of the study drug . Participants must have no plans for conception, sperm donation, or egg donation throughout the study period and for at least 3 months after the last dose of the study drug.\n\nExclusion Criteria:\n\n* Participants have more than 2 facial nodules at screening or randomization;\n* Participants have facial cysts at screening or randomization;\n* Participants have conditions at screening or randomization, which may interfere with the investigator's clinical assessments, including but not limited to: 1) Other facial dermatoses: specific types of acne (e.g., nodulocystic acne, acne conglobata, acne fulminans, etc.), secondary acne (e.g., drug-induced acne, mechanical acne, occupational acne, chloracne, etc.), or other facial rashes due to different conditions (e.g., rosacea, seborrheic dermatitis, solar dermatitis, lupus miliaris disseminatus faciei, psoriasis, eczema, etc.); 2) Facial skin or hair conditions that may interfere with clinical assessments (e.g., prominent beard, sideburns, whiskers, etc.);\n* Participants have systemic diseases with associated skin lesions: e.g., inflammatory bowel disease (Crohn's disease and ulcerative colitis), SAHA syndrome (seborrhea-acne-hirsutism-androgenetic alopecia syndrome), PCOS syndrome (polycystic ovary syndrome), SAPHO syndrome (synovitis-acne-pustulosis-hyperostosis-osteomyelitis), PAPA syndrome (pyogenic sterile arthritis-pyoderma gangrenosum-acne syndrome), hyperandrogenism-insulin resistance-acanthosis nigricans syndrome, congenital adrenal hyperplasia, etc.;\n* Prior use of the topical acne medications or therapies or Use of the systemic medications；\n* Use of skin care products with anti-acne efficacy within 2 weeks prior to randomization;\n* Participants have any serious or unstable medical condition that, in the investigator's judgment, may affect the participant's safety during the study and/or impede study completion, including but not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, or psychiatric disorders."}, 'identificationModule': {'nctId': 'NCT07457294', 'briefTitle': '1% Clascoterone Cream for the Treatment Acne Vulgaris', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of 1% Clascoterone Cream in the Treatment of Acne Vulgaris', 'orgStudyIdInfo': {'id': 'P-WS204(cream)-LC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1% Clascoterone Cream', 'interventionNames': ['Drug: 1% Clascoterone Cream']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': '1% Clascoterone Cream', 'type': 'DRUG', 'description': '1% Clascoterone Cream applied topically to affected areas twice daily for the duration of the study.', 'armGroupLabels': ['1% Clascoterone Cream']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo cream, matching the 1% Clascoterone Cream in appearance, texture, and scent, applied topically to affected areas twice daily for the duration of the study.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jie Wang', 'role': 'CONTACT', 'email': 'wangjie13@3sbio.com', 'phone': '+86 13140705482'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Due to the nature of the study and privacy concerns, de-identified individual participant data will not be made available to external researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}