1% Clascoterone Cream for the Treatment Acne Vulgaris

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: 1% Clascoterone Cream; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 692
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Jie Wang; Phone Number: +86 13140705482; Email: wangjie13@3sbio.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; 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.
Experimental: 1% Clascoterone Cream	Drug: 1% Clascoterone Cream; 1% Clascoterone Cream applied topically to affected areas twice daily for the duration of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Percent change from baseline in ILC at Week 4, Week 8, and Week 12	Week 4, Week 8, and Week 12
Percent change from baseline in NILC at Week 4, Week 8, and Week 12	Week 4, Week 8, and Week 12
Safety: Incidence of adverse events	Week 12

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): May 4, 2026
• Primary Completion (Estimated): August 7, 2028
• Study Completion (Estimated): February 7, 2029

Study Registration Dates

• First Submitted: February 26, 2026
• First Submitted That Met QC Criteria: March 3, 2026
• First Posted (Actual): March 9, 2026

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Skin and Connective Tissue Diseases; Acne Vulgaris
• Other Study ID Numbers: P-WS204(cream)-LC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to the nature of the study and privacy concerns, de-identified individual participant data will not be made available to external researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No