1% Clascoterone Cream for the Treatment Acne Vulgaris

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

• 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); [Time frame: Week 12]

Secondary outcome measures (8)

• Proportion of participants achieving "success" at Week 4 and Week 8 [Time frame: Week 4 and Week 8]
• Absolute change from baseline in NILC at Week 4 and Week 8 [Time frame: Week 4 and Week 8]
• Absolute change from baseline in ILC at Week 4 and Week 8 [Time frame: 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 [Time frame: Week 4, Week 8, and Week 12]
• Percent change from baseline in total lesion count at Week 4, Week 8, and Week 12 [Time frame: Week 4, Week 8, and Week 12]
• Percent change from baseline in ILC at Week 4, Week 8, and Week 12 [Time frame: Week 4, Week 8, and Week 12]
• Percent change from baseline in NILC at Week 4, Week 8, and Week 12 [Time frame: Week 4, Week 8, and Week 12]
• Safety: Incidence of adverse events [Time frame: Week 12]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07457294 · P-WS204(cream)-LC

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗