A Randomized, Double-Blind Study to Compare the Efficacy, Safety and Long-Term Safety of Topical Administration of FMX-101 for 1 Year in the Treatment of Moderate-to-Severe Acne Vulgaris, Study FX2014-05
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 495
- 主要终点
- Percentage of Participants Achieving Investigator's Global Assessments (IGA) Treatment Success at Week 12
研究概览
简要总结
This is a Phase 3 study to evaluate the efficacy, safety and long-term safety of the topical administration of FMX-101, 4% minocycline foam for the treatment of moderate-to-severe acne vulgaris.
详细描述
This is a Phase 3 study to evaluate the efficacy, safety and long-term safety of the topical administration of FMX-101, 4% minocycline foam for the treatment of moderate-to-severe acne vulgaris. The first 12 weeks of the study involves randomized, double-blind treatment with active FMX-101, 4% or matching vehicle. Subjects who successfully complete the 12-week double blind portion of the study will be offered the opportunity to continue in the trial for up to an additional 40 weeks (for a total of 1 year) and receive open-label treatment with FMX-101, 4%.
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
- Double (Participant, Investigator)
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 noninflammatory 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
FMX-101, 4% minocycline foam
FMX-101, 4% minocycline foam applied topically once daily for 12 weeks
干预措施: FMX-101, 4% minocycline foam (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
Percentage of Participants Achieving Investigator's Global Assessments (IGA) Treatment Success at Week 12
时间窗: Baseline and Week 12
The IGA scale for acne vulgaris, was used by the investigators to assess the severity of a participant's acne vulgaris. The scale ranges from 0 (Clear): normal, clear skin with no evidence of acne vulgaris to 5 (Very Severe): highly inflammatory lesions predominate, variable number of comedones, many papules/pustules and many nodulocystic lesions. Higher scores indicated severe outcome. Treatment success was defined as an IGA score of 0 (score of clear) or 1 (almost clear), and at least a 2-grade improvement (decrease) from Baseline.
Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12
时间窗: Baseline and Week 12
To evaluate the efficacy in the treatment of acne compared to vehicle of topical FMX101 4% administered daily for 12 weeks. Changes from Baseline are calculated as Baseline value minus post-Baseline value, so that decreases appear as positive values. Inflammatory lesion count included: papules, pustules, and nodules.
次要结局
- Percentage of Participants Achieving IGA Treatment Success at Week 6 and Week 9(Baseline, Week 6 and Week 9)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)(Double blind: From Baseline until Week 12; Open-label: Week 16 until Week 52)
- Percent Change From Baseline in the Non-inflammatory Lesion Count at Week 12(Baseline and Week 12)
- Absolute Change From Baseline in the Inflammatory Lesion Count at Week 6 and Week 9(Baseline, Week 6 and Week 9)