Study of Laser Treatment of Melasma

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the RevLite laser in the treatment of refractory mixed type melasma.

Official Title
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A Study of the RevLite Q-Switched Nd:YAG Laser System With Smart Infinite (SI) Handpiece for the Treatment of Refractory Mixed Type Melasma

Conditions
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Refractory Mixed Type Melasma

Intervention / Treatment
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* Device: Q-Switched Nd:YAG Laser (RevLite)
* Drug: Retin-A and microdermabrasion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser treatment<br>Laser treatment and microdermabrasion and topical lightening agent regimen | Device: Q-Switched Nd:YAG Laser (RevLite)<br>* Laser treatment added to a microdermabrasion and topical lightening agent regimen<br>Drug: Retin-A and microdermabrasion<br>* Microdermabrasion and topical lightening agent regimen<br>|
| Active Comparator: Control<br>Microdermabrasion and topical lightening agent regimen | Drug: Retin-A and microdermabrasion<br>* Microdermabrasion and topical lightening agent regimen<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Melasma Area Severity Assessment (MASI) Score Change From Baseline to Follow Up | 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. | 3 Months |