NCT01111994Unknown4 期
Efficacy & Safety of Clindamycin Phosphase 1.2% and Tretinoin 0.025% Gel vs. Vehicle for the Treatment of Acne and Acne-Induced Post Inflammatory Hyperpigmentation in Patients With Skin of Color
Callender Center for Clinical Research4 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2009年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Improvement of acne and post inflammatory hyperpigmentation
研究概览
简要总结
The purpose of this study is ascertain the efficacy and safety of Clindamycin
Phosphate 1.2% and Tretinoin 0.025% in the treatment of Acne and Post
Inflammatory Hyperpigmentation in patients with skin of color.
详细描述
Acne is a chronic disorder of the pilosebaceous glands characterized by
inflammatory papules, pustules, opened and closed comedones, cysts and
nodules. Post inflammatory hyperpigmentation is a condition in which an
inflammation from a disease such as acne, trauma, or abrasion results in areas
of the skin with increased melanin content compared to the surrounding skin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild to moderate facial acne and mild to moderate post-inflammatory hyperpigmentation
- •Photo skin types IV - VI
- •Ages 12 and older
- •Both sexes
- •Two week washout period for topical anti-acne medications, medicated cosmetics,and bleaching products
- •Thirty day washout period for oral corticosteroids, oral antibiotics,and oral contraceptives
排除标准
- •Seborrheic dermatitis
- •PIH of solely dermal origin
- •Acne vulfaris known to be resistant to oral antibiotics
- •Use of erythromycin-containing products
- •Use of neuromuscular blocking agents
- •Pregnancy, breastfeeding, a positive pregnancy test in the office, or plans to become pregnant. Women of childbearing age must use reliable forms of contraception (e.g., abstinence, oral contraceptives, or spermicide and condoms).
结局指标
主要结局
Improvement of acne and post inflammatory hyperpigmentation
时间窗: 3 months
次要结局
未报告次要终点
研究者
研究点 (4)
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