EUCTR2006-004215-21-HU进行中（未招募）不适用
A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO DEMONSTRATE THE EFFICACY AND SAFETY OF ADAPALENE/BENZOYL PEROXIDE TOPICAL GEL COMPARED WITH ADAPALENE TOPICAL GEL, 0.1%; BENZOYL PEROXIDE TOPICAL GEL, 2.5% AND TOPICAL GEL VEHICLE IN SUBJECTS WITH ACNE VULGARIS
Galderma Research & Development Inc.0 个研究点目标入组 1,656 人开始时间: 2006年10月20日最近更新:
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试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,656
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
- •1. Male and female subjects 12 years of age or older.
- •2. A clinical diagnosis of acne vulgaris with facial involvement.
- •3. A minimum of 20 but not more than 50 Inflammatory lesions (papules and pustules) on the face (excluding the nose) and not more than one acne nodule.
- •4. A minimum of 30 but not more than 100 Noninflammatory lesions (open comedones and closed comedones) on the face (excluding the nose).
- •5. A score of 3 (Moderate) on the Investigator’s Global Assessment Scale.
- •6. Females of childbearing potential (including pre-menstrual subjects) with a negative urine pregnancy test (UPT) or females of non-childbearing potential, defined as post menopausal (absence of menstrual bleeding for 1 year prior to enrollment), hysterectomy or bilateral oophorectomy.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. More than one acne nodule.
- •2. Any acne cyst.
- •3. Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or severe acne requiring systemic treatment.
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