A Pilot Study Comparing the Efficacy of Glycolic Acid Peels vs. Salicylic Acid Peels for the Treatment of Melasma: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Change in best overall cosmetic appearance (right side or left side better)rated by a blinded dermatologist from baseline to week 16
研究概览
简要总结
The purpose of this study is to find out the safety and effectiveness of Glycolic Acid Chemical Peels compared to Salicylic Acid Chemical Peels for the treatment of melasma.
详细描述
Participants in this study will be patients who are clinically diagnosed with at least a 2 x 2 cm patch of melasma on each side of their face (forehead or cheek). One half of the subject's face will be randomly selected to receive 4 treatments of 30% glycolic acid peels and the other half of the face will receive 4 treatments of 30% salicylic acid peels/ weeks 0, 4, 8, and 12. Follow up visit will be at week 16. This study is a pilot study designed to determine feasibility of these procedures.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects aged 18 years or older
- •Subjects with at least a 2 x 2 cm patch of melasma on each side of the face (forehead or cheek)
- •Subjects in general good health
- •Subjects must be willing and able to understand and provide informed consent for the use of their tissue and communicate with the investigator
- •Subjects must be willing to not apply other treatment options for melasma during the course of the study
排除标准
- •Subjects under 18 years of age
- •Subjects who are pregnant and/or lactating
- •Subjects who are unable to understand the protocol or to give informed consent
- •Subjects diagnosed with mental illness
- •Subjects who have concurrent active uncontrolled disease to facial area (i.e uncontrolled acne)
- •Subjects who have had a chemical peel in the past 3 months
- •Subjects who have used a prescribed retinoid in the past 3 months
- •Subjects with a bleeding disorder
- •Subjects with a history of abnormal wound healing
- •Subjects with a history of abnormal scarring
研究组 & 干预措施
Salicylic Acid Peels
Salicylic Acid and Glycolic Acid Chemical Peels are skin treatments used to correct uneven texture and color by removing dead cells from the skin's top layer.
干预措施: Salicylic Acid Peels (Other)
Glycolic Acid Peels
Salicylic Acid and Glycolic Acid Chemical Peels are skin treatments used to correct uneven texture and color by removing dead cells from the skin's top layer.
干预措施: Glycolic Acid Peels (Other)
结局指标
主要结局
Change in best overall cosmetic appearance (right side or left side better)rated by a blinded dermatologist from baseline to week 16
时间窗: 1 hour at baseline and week 16
The primary outcome was a blinded rating of the treatment area (Salicylic Acid Peels Versus Glycolic Acid Peels) with the best overall cosmetic appearance. A dermatologist will blindly evaluate the treated areas of each side from live subjects at baseline and on the final follow up visit (week 16).
次要结局
未报告次要终点
研究者
Murad Alam
Professor in Dermatology, Otolaryngology - Head and Neck Surgery, and Surgery-Organ Transplantation
Northwestern University