A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 for 12 Weeks in the Treatment of Moderate-to-Severe Acne Vulgaris (Study FX2017-22)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,488
- 试验地点
- 97
- 主要终点
- The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12.
研究概览
简要总结
A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 for 12 Weeks in the Treatment of Moderate-to-Severe Acne Vulgaris (Study FX2017-22)
详细描述
This is a randomized, multicenter, double-blind, vehicle-controlled, 2 arm study to evaluate the safety and efficacy over 12 weeks of FMX101 topical foam containing 4% minocycline compared to vehicle in the treatment of subjects with moderate-to-severe facial acne vulgaris. Qualified subjects will be randomized to receive 1 of the following 2 treatments:
- FMX101 4% minocycline foam
- Vehicle foam
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 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, 4% minocycline foam
FMX101, 4% minocycline foam applied topically once daily for 12 weeks
干预措施: FMX101 (Drug)
Vehicle foam
Vehicle foam applied topically once daily for 12 weeks
干预措施: Vehicle Foam (Drug)
结局指标
主要结局
The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12.
时间窗: 12 weeks
A decrease in the inflammatory lesion count from Baseline to Week 12.
Investigator Global Assessment (IGA) Treatment Success (Dichotomized as Yes/no) at Week 12, Where Success is Defined as an IGA Score of 0 or 1, and at Least a 2-grade Improvement (Decrease) From Baseline
时间窗: 12 weeks
次要结局
- The Absolute Change From Baseline in the Non-inflammatory Lesion Count at Week 12(12 weeks)
- IGA Treatment Success (Dichotomized as Yes/no) at Week 9, Where Success is Defined as an IGA Score of 0 or 1, and at Least a 2-grade Improvement (Decrease) From Baseline at the Interim Visit at Week 9(9 weeks)
- The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 9(9 weeks)
- The Absolute Change From Baseline in the Inflammatory Lesion Count at the Interim Visit at Week 6(6 weeks)
- IGA Treatment Success (Dichotomized as Yes/no) at Week 6, Where Success is Defined as an IGA Score of 0 or 1, and at Least a 2-grade Improvement (Decrease) From Baseline at the Interim Visit at Week 6(6 weeks)