NCT07457294
尚未招募
3 期
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
Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.0 个研究点目标入组 692 人开始时间: 2026年5月4日最近更新:
概览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.
- 入组人数
- 692
- 主要终点
- 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);
概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
1% Clascoterone Cream
Experimental
干预措施: 1% Clascoterone Cream (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
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);
时间窗: Week 12
次要结局
- 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)
- 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)
- 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)
研究者
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