NCT01474590已完成3 期
Efficacy and Safety Comparison of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Associated With 200 mg Doxycycline Capsules Versus Vehicle Gel Associated With Isotretinoin Capsules in the Treatment of Severe Acne
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 266
- 试验地点
- 1
- 主要终点
- The Primary Outcome is Overall Success, a Composite Endpoint Including Efficacy and Safety Measurements
研究概览
简要总结
Non-inferiority, randomized, controlled, multi-center, investigator-blind, parallel-group comparison study in subjects with severe acne vulgaris on the face.
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
- Single (Investigator)
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 subject of any race, aged 12 to 35 years inclusive
- •Subject weighing between 50 and 110 kg
- •Subject with severe acne (IGA at least 4), which in the opinion of the investigator is appropriate for treatment with oral isotretinoin (severe nodular acne, severe inflammatory acne, recalcitrant acne; all unresponsive to conventional first line therapies)
- •Subject with at least 5 nodules on the face
排除标准
- •Subject with clinically abnormal results to blood testings performed at screening
- •Subject with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), pyoderma faciale, sinus tracks
- •Female subject who is pregnant, nursing or planning a pregnancy during the study
- •Subject with known history of hepatic and/or renal insufficiency, to be confirmed by blood testings
- •Subject with known metabolic or structural bone disease (for 12-17 years old population)
- •Subject with bowel disease and/or with hypervitaminosis A
- •Subject who presents with treated or untreated depression or has a history of depression including a family history of major depression
- •Subject with a wash-out period from baseline for topical treatment on the face less than : Corticosteroids, antibiotics, antibacterials, antiseptics, retinoids, other anti-inflammatory drugs or other acne treatments (2 weeks); Cosmetic procedures (1 week); Photodynamic therapy and laser therapy for acne (3 months)
- •Subject with a wash-out period from baseline for systemic treatment less than: Corticosteroids, antibiotics (4 weeks),Progesterone for contraception (3 months); Spironolactone(3 months); Other acne treatments (6 months);Cyproterone acetate(6 months)
研究组 & 干预措施
Epiduo/Tactuo + doxycycline 200mg
Experimental
干预措施: Epiduo/Tactuo (Drug)
Epiduo/Tactuo + doxycycline 200mg
Experimental
干预措施: doxycycline 200mg (Drug)
Isotretinoin + vehicle gel
Active Comparator
干预措施: vehicle gel (Other)
Isotretinoin + vehicle gel
Active Comparator
干预措施: Isotretinoin (Drug)
结局指标
主要结局
The Primary Outcome is Overall Success, a Composite Endpoint Including Efficacy and Safety Measurements
时间窗: 20 weeks
Overall success is reached when the 2 following criteria are fulfilled : 1. Overall efficacy: reduction of at least 75% of number of nodules at the end of treatment 2. Safe treatment: Absence of any listed safety issues
次要结局
未报告次要终点
研究者
研究点 (1)
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