1% Clascoterone Cream for the Treatment Acne Vulgaris

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• 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); [Срок оценки: Week 12]

Вторичные конечные точки (8)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07457294 · P-WS204(cream)-LC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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