EUCTR2010-022919-20-Outside-EU/EEA
进行中（未招募）
不适用
Multi-centre, randomized, double-blind trial to compare the efficacy and safety of tretinoin clindamycin phosphate gel to clindamycin phosphate gel alone 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 2,010 人2012年3月7日
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Treatment of Acne vulgaris
- 发起方
- Dow Pharmaceutical Sciences
- 入组人数
- 2010
- 状态
- 进行中（未招募）
- 最后更新
- 14年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •Male or female subjects of any race;
- •12 years of age or older;
- •acne vulgaris;
- •20 to 50 inflammatory lesions (papules and pustules);
- •20 to 100 noninflammatory lesions (open and closed comedones);
- •no more than 2 nodules;
- •Evaluator’s Global Severity Score (EGSS) of moderate (\=3\) or severe (\=4\).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1320
- •F.1\.2 Adults (18\-64 years) yes
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
结局指标
主要结局
未指定
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