Efficacy and Safety Comparison of Epiduo Gel Associated With Lymecycline 300 mg Capsules Versus Epiduo Vehicle Gel Associated With Lymecycline 300 mg Capsules in the Treatment of Moderate to Severe Acne Vulgaris
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 378
- 试验地点
- 1
- 主要终点
- Percent Change From Baseline in Total Lesion Count
研究概览
简要总结
Randomized, controlled, multi-center, double-blind, parallel-group comparison study in Subjects with moderate to severe acne vulgaris on the face.
The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% / Benzoyl Peroxide (BPO) 2.5% Gel associated with Lymecycline 300mg Capsules compared to Adapalene 0.1% /Benzoyl Peroxide 2.5% Vehicle Gel associated with Lymecycline 300mg Capsules, in the treatment of moderate to severe acne vulgaris.
The safety of the two treatment regimens will also be evaluated.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female Subjects of any race, aged 12 to 35 years inclusive,
- •Subjects with moderate to severe facial acne vulgaris (Investigator's Global Assessment score of 3 or 4),
排除标准
- •Subjects with more than 3 nodules or cysts on the face
- •Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.),
- •Subjects with a wash-out period for topical treatment on the face less than: Corticosteroids, antibiotics, antibacterials, antiseptics, retinoids, other anti-inflammatory drugs or other acne treatments (2 weeks), Zinc containing drugs (1 week), Phototherapy devices for acne and cosmetic procedures (1 week)
- •Subjects with a wash-out period for systemic treatment less than:Acne therapy containing zinc (4 weeks), Corticosteroids, antibiotics (4 weeks), Other acne treatments (6 months), Ciproterone acetate / Chlormadinone acetate (6 months), Spironolactone / Drospirenone (3 months)
- •Subjects with impaired hepatic (ALT/AST > 3xULN and bilirubin > 1.5xULN) or renal (creatinine clearance greater than 60 ml/min) functions based on a blood sample,
- •Subjects with known intolerance to lactose,
研究组 & 干预措施
Adapalene 0.1% / BPO 2.5% gel
干预措施: Adapalene/ BPO gel with Lymecycline capsules (Drug)
Adapalene 0.1% / BPO 2.5% Vehicle Gel
干预措施: Adapalene/ BPO vehicle gel with Lymecycline capsules (Drug)
结局指标
主要结局
Percent Change From Baseline in Total Lesion Count
时间窗: Baseline and Week 12
Percent change from Baseline in Total Lesion count (sum of Non-Inflammatory and Inflammatory lesions) at Week 12.
次要结局
- Success Rate on the Investigator's Global Assessment (IGA) at Week 12(Baseline and Week 12)