The Efficacy of Salicylic Acid Peels Combined With 4% Hydroquinone Cream Versus 4% Hydroquinone Cream Alone in the Treatment of Hispanic Women With Moderate to Severe Melasma
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of Participants Showing Improvement of Melasma Based on Mexameter Readings
研究概览
简要总结
This study will enroll 20 adult Hispanic women. Participants will apply 4% hydroquinone cream twice daily to affected areas on the face for 14 weeks and half the face will be peeled with 20-30% salicylic acid every two weeks for a total of 4 peels. The first two peels will be 20% salicylic acid and the second two peels will be with 30% salicylic acid. The purpose of the study will be to evaluate the safety and efficacy of salicylic acid combined with 4% hydroquinone versus 4% hydroquinone alone.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Hispanic women ages 18-65 years of age with moderate to severe melasma
- •English and Spanish-speaking women
排除标准
- •Pregnant or breast-feeding women
- •Subjects who have used 4% hydroquinone within 3 months of study start
- •Subjects who have used chemical peels, microdermabrasion or facial laser treatments within 9 months of study start
研究组 & 干预措施
A
Subjects randomized to have the right side of the face peeled with salicylic acid every 2 weeks for a total of 4 peels (first 2 at 20% and last 2 at 30%). Subjects will apply 4% hydroquinone cream to affected areas on entire face for 14 weeks.
干预措施: 20-30% Salicylic Acid peels to the right side of the face (Drug)
B
Subjects randomized to have the left side of the face peeled with salicylic acid every 2 weeks for a total of 4 peels (first 2 at 20% and last 2 at 30%). Subjects will apply 4% hydroquinone cream to affected areas on entire face for 14 weeks.
干预措施: 20-30% Salicylic Acid peels to the left side of the face (Drug)
结局指标
主要结局
Number of Participants Showing Improvement of Melasma Based on Mexameter Readings
时间窗: 14 weeks
Improvement of melasma on the peel side using mexameter reading
次要结局
未报告次要终点
研究者
Amit Pandya
Professor of Dermatology
University of Texas Southwestern Medical Center