Reatment of Melasma Using Q-switched Nd: YAG Laser and Fractional CO2 Laser Separately and in Combination
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- percentage of clinical improvement
研究概览
简要总结
- All participants will be divided into 2 groups : Group A & Group B.
- Group A will be subjected to 3 consecutive sessions of Q-switched 1,064 nm Nd: YAG laser to one side of the face & fractional co2 laser to the other side of the face with one month interval between sessions.
- Group B will be subjected also to 3 consecutive sessions of Q-switched 1,064 nm Nd: YAG laser to one side of the face & an additional fractional co2 laser to the other side of the face using the above mentioned parameters with one month interval between sessions.
- Response to treatment will be assessed using the Melanin Index (MI) score, Melasma Area and Severity Index (MASI) score, spectrophotometer ( Derma catch, colorix, Neuchatel, Switzerland ) and a subjective self-assessment method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •melasma patients above 18 years
排除标准
- •Pregnancy.
- •Usage of chemical peeling 1 month prior to the study.
- •Isotretinoin intake 6 months prior to the study.
- •Any laser procedure related to melasma lesions 1 month prior to the study.
- •Active herpetic lesions.
- •Any concurrent active skin disease within the treated area.
- •Photosensitive skin conditions such as systemic lupus erythematous.
- •History of delayed wound healing.
- •Keloid formation.
- •Bleeding diathesis.
- •Medical conditions such as diabetes mellitus & autoimmune diseases.
结局指标
主要结局
percentage of clinical improvement
时间窗: 6 months to 1 year
Evaluate the efficacy of Q-switched 1,064nm Nd: YAG \& fractional Co2 laser in the treatment of melasma by comparing the results of masked dermatologists' observation of clinical photographs before treatment and after treatment and follow-p period.
Melanin index change.
时间窗: 6 months to 1 year
Evaluate the efficacy of Q-switched 1,064nm Nd: YAG \& fractional Co2 laser in the treatment of melasma by comparing the results by taking spectrophotometer readings (melanin index) before treatment and after treatment and follow-p period.
patient satisfaction rate
时间窗: 6 months to 1 year
Evaluate the efficacy of Q-switched 1,064nm Nd: YAG \& fractional Co2 laser in the treatment of melasma by comparing patient satisfaction before treatment and after treatment and follow-p period.
Modified Melasma Area and Severity index change.
时间窗: 6 months to 1 year
Evaluate the efficacy of Q-switched 1,064nm Nd: YAG \& fractional Co2 laser in the treatment of melasma by comparing the results through measuring modified MASI score before treatment and after treatment and follow-p period.
次要结局
- Melanin index change.(6 months to 1 year)
- patient satisfaction rate(6 months to 1 year)
- Modified Melasma Area and Severity Index change.(6 months to 1 year)
- percentage of clinical improvement(6 months to 1 year)
研究者
Rana F Hilal, MD
Lecturer of dermatology
Kasr El Aini Hospital