ACTRN12613000756729已完成2 期
A Phase II, randomized, active and vehicle controlled, Investigator blind, multi-centre study to evaluate the efficacy, safety and tolerability of topically applied tretinoin formulated with TPM as an anti-acne preparation in human subjects with acne vulgaris.
Phosphagenics0 个研究点目标入组 45 人开始时间: 2013年7月5日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 12 Years 至 30 Years（—）
- 性别
- All
入选标准
- •* Minimum of 15 and Maximum of 60 inflammatory lesions on the face (papules and/ or pustules) and no more than one small nodulocystic lesion;
- •* Existence of a minimum of 50 non-inflammatory lesions on the face (blackheads/whiteheads);
- •* A score of 2 or 3 on the Investigator's Global Assessment (IGA) scale;
- •* Willing to minimise exposure to the sun, and avoid tanning booths and solariums
排除标准
- •* Severe acne vulgaris
- •* Facial skin condition other than acne vulgaris
- •* Facial hair, excessive scarring, sunburn or other disfigurement that may obscure assessment of acne counts or severity
- •* History of retinoid intolerance
- •* Subjects that are on topical/systemic acne treatment that does not meet the washout period
- •* Nursing/pregnant women
- •* The women were planning for pregnancy
研究者
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