NCT01335581已完成不适用
A Study of the RevLite Q-Switched Nd:YAG Laser System With Smart Infinite (SI) Handpiece for the Treatment of Refractory Mixed Type Melasma
ConBio, a Cynosure Company1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2011年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Melasma Area Severity Assessment (MASI) Score Change From Baseline to Follow Up
研究概览
简要总结
The purpose of this study is to evaluate the RevLite laser in the treatment of refractory mixed type melasma.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fitzpatrick Skin Type III-VI
- •mixed (epidermal and dermal) melasma diagnosed by Wood's Lamp exam
- •age 18 or older
- •melasma persisting for greater than 6 months that has failed to respond to conventional treatment with hydroquinone or other topical lightening agents
- •written and verbal informed consent
- •willing and able to comply with study instructions and return to the clinic for required visits
排除标准
- •Pregnancy, breastfeeding, taking birth control pills or plans to become pregnant during the study
- •history of cutaneous photosensitization, porphyria, and hypersensitivity to porphyrins or photodermatosis
- •any skin pathology or condition that could interfere with the evaluation or requires the use of interfering topical or systemic therapy
- •uncorrected coagulation defect or is currently using anti-coagulation medication (including but not limited to heavy aspirin therapy)
- •any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study
- •currently enrolled in an investigational drug or device trial, or has received an investigational drug or has been treated with an investigational device within 30 days prior to entering this study
- •inability to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function
- •unreliability for the study (this includes subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits)
- •use of photosensitizing drugs within a timeframe where photosensitization from these drugs may still be present
- •need to be exposed to artificial tanning devices or excessive sunlight during the trial
- •Diabetes Type I or II
- •sensitivity to hydroquinone or Retin-A
- •evidence of a compromised immune system or hepatitis
- •use of bleaching creams or retinoids within the last 30 days
研究组 & 干预措施
Laser treatment
Experimental
Laser treatment and microdermabrasion and topical lightening agent regimen
干预措施: Retin-A and microdermabrasion (Drug)
Control
Active Comparator
Microdermabrasion and topical lightening agent regimen
干预措施: Retin-A and microdermabrasion (Drug)
结局指标
主要结局
Melasma Area Severity Assessment (MASI) Score Change From Baseline to Follow Up
时间窗: 3 Months
The severity of the melasma is assessed based on a photographic scale. The scale ranges from 0 to 48, with 48 being the most severe. A decrease in the MASI score from the baseline to the follow up corresponds with decreasing severity.
次要结局
未报告次要终点
研究者
研究点 (1)
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