NCT02593383已完成1 期
A Placebo Control, Multicenter, Randomized, Double Blind, Multi-formula Groups, and Parallel Phase Ⅰb+Ⅱa Study Evaluating the Safety and Efficacy of Compound Adapalene and Clindamycin Hydrochloride Gel in Treatment of Patients With Acne
Lee's Pharmaceutical Limited1 个研究点 分布在 1 个国家目标入组 245 人开始时间: 2015年3月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 245
- 试验地点
- 1
- 主要终点
- efficacy endpoint
研究概览
简要总结
evaluate the safety and efficacy of Compound Adapalene and Clindamycin Hydrochloride Gel in treatment of chinese patients with acne.
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
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 18 to 40 years old, female or male;
- •Class I-III of Acne vulgaris according to the International Modified PILLSBURY Classification;
- •Patients voluntarily take part in the study and sign the ICF.
排除标准
- •The subject is known to be allergic to adapalene, clindamycin hydrochloride, clindamycin, and / or any components of gel excipient;
- •Patients with secondary acne including occupational acne and corticosteroid-induced acne;
- •The affected skin has other concomitant lesion (such as solar dermatitis, psoriasis, seborrheic dermatitis, eczema and extremely severe acne) which may impact the efficacy evaluation;
- •Subject has the history of regional enteritis, ulcerative colitis or antibiotic-associated colitis;
- •Patient has history of severe cardiac disease and hypertension;
- •Patient has severe liver and kidney diseases with AST/ALT more than twice upper limitation, or Cr, total cholesterol and triglycerides above normal range;
- •Patients with severe endocrine diseases, blood diseases, and neuropsychiatric disorders;
- •Patients are known to have severe immune dysfunction, or need long-term use of corticosteroids or immunosuppressive agents;
- •Pregnant or breastfeeding women, or unwilling to take effective contraceptive measures during the study;
- •Alcoholic patients or drug abusers;
- •Patient has used other acne drugs topically within 2 weeks before the study start;
- •Patient has been administered with victoria A acid, vitamins, and antibiotics within 4 weeks before the study start;
- •Patient has participated in other study within 3 months before the study start;
- •The subject is not fit to take part in this study in the judgment of the investigator.
研究组 & 干预措施
Treat group 1
Experimental
Group 1: 0.1% Adapalene + 1% Clindamycin Hydrochloride
干预措施: Adapalene + Clindamycin Hydrochloride (Drug)
Treatment group 2
Experimental
Group 2: 0.1% Adapalene + 2% Clindamycin Hydrochloride
干预措施: Adapalene + Clindamycin Hydrochloride (Drug)
Treatment group 3
Experimental
Group 3: 0.05% Adapalene + 0.5% Clindamycin Hydrochloride
干预措施: Adapalene + Clindamycin Hydrochloride (Drug)
Treatment group 4
Experimental
Group 4: 0.05% Adapalene + 1% Clindamycin Hydrochloride
干预措施: Adapalene + Clindamycin Hydrochloride (Drug)
Placebo group
Placebo Comparator
Placebo Group: Blank Gel
干预措施: Placebo (Drug)
结局指标
主要结局
efficacy endpoint
时间窗: 12 weeks
number of patients with deceased acne lesions at the treatment end (Day 85±3) in each group;
次要结局
- treatment success rate(12 weeks)
- PK(12 weeks)
- IGA classification change(12 weeks)
研究者
研究点 (1)
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