A Pilot Study Comparing the Efficacy of 1064 Q-switch Laser vs. Glycolic Acid Peels for the Treatment of Melasma: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Visual Analog Scale (VAS) of Improvement Rated by a Blinded Dermatologist From at Week 10
研究概览
简要总结
The purpose of this study is to find out the safety and effectiveness of 1064 Q-Switch Laser Therapy compared to Glycolic Acid Chemical Peels for the treatment of melasma.
详细描述
Participants in this study will be patients at the dermatology clinic who are clinically diagnosed with at least a 2X2 cm patch of melasma on each side of their face (forehead or cheek). Starting at 2 weeks before treatment (week 2), both sides will be pretreated and primed with 4% hydroquinone with, if necessary, 2.5% hydrocortisone cream BID. On the treatment day (2-weeks) and 6-weeks one half of the subject's face will receive glycolic acid peels and the other half of the face will receive 1064nm Q-switch laser. 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
- •Subjects who report being allergic to glycolic acid
结局指标
主要结局
Visual Analog Scale (VAS) of Improvement Rated by a Blinded Dermatologist From at Week 10
时间窗: Week 10
The primary outcome was a blinded rating of improvement of the treatment area (1064nm Q-switch Laser Versus Glycolic Acid Peels) using a Visual Analog Scale (VAS). A dermatologist blindly evaluated the treated areas of each side from live subjects at baseline on the final follow up visit (week 10). The VAS of improvement was rated on a scale of 0 to10, with 0 being no improvement and 10 being the most improvement seen by the treatment.
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