A Phase 3, Multi-center, Randomized, Double-Blind, Vehicle-controlled Study to Evaluate the Efficacy and Safety of Topical Administration of Minocycline Hydrochloride Foam (4%) in the Treatment of Moderate-to-Severe Acne Vulgaris
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 372
- 试验地点
- 29
- 主要终点
- ILC
研究概览
简要总结
This is a randomized, multicenter, double-blind, vehicle-controlled, 2-arm study to evaluate the safety and efficacy in 12 weeks of FMX101 minocycline foam, 4%, compared to vehicle, in the treatment of subjects with moderate to severe facial acne vulgaris.
详细描述
Qualified subjects will be randomized to receive 1 of the following 2 treatments:
- FMX101 4% minocycline foam
- Vehicle foam
Subjects with qualifying lesion counts and Investigator's Global Assessments (IGA) of acne severity scores and will be assigned to 1 of 2 treatments according to the randomization schedule. Subjects will apply the assigned study drug topically once daily for 12 weeks as directed. Subjects will be advised to apply the study drug at approximately the same time each day, preferably in the evening at bedtime. Both the Investigator and subject will be blinded to the study drug identity.
Subjects will return for visits at Weeks 1, 2, 4, 6, 8, and 12. At the discretion of the clinic staff, for the convenience of subjects or clinic staff, visits can be scheduled to occur 2 days before or after the nominal schedule date for the Weeks 1, 2, 4, 8 and 12 visits. Efficacy evaluations (acne lesion counts and IGAs) will be performed at each visit during the study.
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
- 9 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has completed and signed an appropriately administered Informed Consent Form (ICF) prior to any study-related procedures. Subjects less than 18 years of age (or as required by state law) must sign an Assent Form for the study and a parent or legal guardian must sign the ICF.
- •Has facial acne vulgaris with:
- •20 to 50 inflammatory lesions (papules, pustules, and nodules)
- •25 to 100 non-inflammatory lesions (open and closed comedones)
- •No more than 2 nodules on the face
- •IGA score of moderate (3) to severe (4)
- •Willing to use only the supplied non-medicated cleanser (Cetaphil Gentle Skin Cleanser) and to refrain from use of any other acne medication, medicated cleanser, excessive sun exposure, and tanning booths for the duration of the study.
排除标准
- •Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne), or any dermatological condition of the face or facial hair (eg, beard, sideburns, mustache) that could interfere with the clinical evaluations.
- •Sunburn on the face.
研究组 & 干预措施
FMX101
FMX101 4% minocycline foam
干预措施: FMX101 (Drug)
Vehicle Foam
Vehicle Foam
干预措施: FMX101 (Drug)
结局指标
主要结局
ILC
时间窗: Week12
The efficacy assessments will inflammation lesion counts at week12
次要结局
- nILC(week 12)
- ILC week4(week 4)
- ILC week8(week 8)
- Investigator Global Assessment (IGA) week4(Week 4)
- Investigator Global Assessment (IGA) week8(Week 8)
- Investigator Global Assessment (IGA)(week 12)