NCT02110134已完成不适用
A Study of the RevLite Laser System for the Treatment of Refractory Mixed Type Melasma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Rates of Adverse Events Among Patients
研究概览
简要总结
The purpose of this study is to compare a hydroquinone skin care regimen alone to a combination of Revlite Laser treatment with a hydroquinone skin care regimen for the treatment of melasma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Device Feasibility
- 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
- •Subjects with Fitzpatrick Skin Type III-VI
- •Subjects with mixed (epidermal and dermal) type melasma diagnosed by Wood's Lamp.
- •Subjects who are over the age of 18 years of age
- •The subject is willing and able to comply with study instructions and return to the clinic for required visits.
- •The subject's melasma has persisted for greater than 6 months
排除标准
- •The subject is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
- •The subject has a history of cutaneous photosensitization, porphyria, and hypersensitivity to porphyrins or photodermatosis.
- •The subject has any skin pathology or condition that could interfere with the evaluation or requires the use of interfering topical or systemic therapy.
- •The subject has an uncorrected coagulation defect or is currently using anti-coagulation medication (including but not limited to heavy aspirin therapy).
- •The subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
- •The subject is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 30 days prior to entering this study.
- •The subject has used photosensitizing drugs (e.g., Declomycin, sulfa antibiotics, phenothiazines, etc.) within a timeframe where photosensitization from these drugs may still be present.
- •The subject has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.
- •The subject has had prior treatment with parenteral gold therapy (gold sodium thiomalate).
- •The subject has Diabetes Type 1 or
- •The subject has a sensitivity to hydroquinone or Retin-A.
- •The subject has evidence of a compromised immune system or hepatitis.
- •Has had microdermabrasion in past 3 months, other laser or Intense Pulsed Light treatment or chemical peels to the face in past 6 months, injectable fillers, topical retinoids, over-the-counter anti-aging products past 2 weeks.
- •Has a history of keloids or hypertrophic scarring
- •Has permanent make-up and/or is unwilling to refrain from using semi-permanent cosmetics during study
结局指标
主要结局
Rates of Adverse Events Among Patients
时间窗: From study baseline to completion, approximately 1 year. However, adverse events not resolved by then will be followed up with until they are resolved.
Adverse events were collected and reported to test the safety and efficacy of the device.
次要结局
- Satisfaction Questionnaire(1 month post last treatment)
- Photographic Evaluation using the Global Aesthetic Improvement Scale(1 month post last treatment)
研究者
研究点 (1)
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