EUCTR2010-022918-15-Outside-EU/EEA进行中（未招募）不适用
Multi-centre, randomized, double-blind, active- and vehicle-controlled trial to compare the efficacy and safety of tretinoin clindamycin phosphate gel to clindamycin phosphate gel alone, tretinoin gel alone, and vehicle in the treatment of acne vulgaris in patients from 12 to less than 18 years of age.
Dow Pharmaceutical Sciences0 个研究点目标入组 1,288 人开始时间: 2012年3月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,288
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male or female subjects of any race
- •12 years of age or older
- •acne vulgaris
- •20-50 inflammatory lesions (papules and pustules)
- •20-100 non-inflammatory lesions (open and closed comedones)
- •= 2 nodules.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 795
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 493
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobata, acne fulminans, secondary acne, etc;
- •Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy;
- •Female subjects who are pregnant, nursing mothers, planning a pregnancy during the course of the trial, or become pregnant during the study;
- •History of regional enteritis, ulcerative colitis or antibiotic-associated colitis;
- •Treatment of any type for cancer within the last 6 months;
- •History of hypersensitivity or allergic reactions to any of the study preparations as described in the Investigator’s Brochure, including known sensitivities to any dosage form of clindamycin, lincomycin or tretinoin;
- •Recent history or concurrent use of certain topical or systemic medication.
研究者
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