1% Clascoterone Cream for the Treatment Acne Vulgaris

NCT07457294 | Not Yet Recruiting Phase 3

• 1 other identifier: P-WS204(cream)-LC
• Study Type: interventional
• Target: 692
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. Target population: Participants aged ≥12 years with moderate to severe acne vulgaris who meet the inclusion criteria and none of the exclusion criteria. Treatment: 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.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• 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);

  Week 12

Secondary Outcomes (8)

• Proportion of participants achieving "success" at Week 4 and Week 8

  Week 4 and Week 8

• Absolute change from baseline in NILC at Week 4 and Week 8

  Week 4 and Week 8

• Absolute change from baseline in ILC at Week 4 and Week 8

  Week 4 and Week 8

• Absolute change from baseline in total lesion count (inflammatory and non-inflammatory lesions) at Week 4, Week 8, and Week 12

  Week 4, Week 8, and Week 12

• Percent change from baseline in total lesion count at Week 4, Week 8, and Week 12

  Week 4, Week 8, and Week 12

Study Arms (2)

1% Clascoterone Cream

EXPERIMENTAL

Drug: 1% Clascoterone Cream

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

1% Clascoterone Cream DRUG

1% Clascoterone Cream applied topically to affected areas twice daily for the duration of the study.

1% Clascoterone Cream

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Age ≥12 years at the time of ICF signing, regardless of gender;
• 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);
• 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;
• 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.

You may not qualify if:

• Participants have more than 2 facial nodules at screening or randomization;
• Participants have facial cysts at screening or randomization;
• 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.);
• 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.;
• Prior use of the topical acne medications or therapies or Use of the systemic medications；
• Use of skin care products with anti-acne efficacy within 2 weeks prior to randomization;
• 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.

Sponsors & Collaborators

• Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.: lead

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Central Study Contacts

Jie Wang

CONTACT

+86 13140705482; wangjie13@3sbio.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 9, 2026
• Study Start: May 4, 2026
• Primary Completion (Estimated): August 7, 2028
• Study Completion (Estimated): February 7, 2029
• Last Updated: March 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share