A Pilot Study Testing 1064nm Q-switch Laser Versus Glycolic Acid Peels for the Treatment of Melasma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Pilot Study Comparing the Efficacy of 1064 Q-switch Laser vs. Glycolic Acid Peels for the Treatment of Melasma: A Randomized Control Trial

Conditions
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Melanosis

Intervention / Treatment
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* Device: 1064nm Q-switch Laser
* Other: Glycolic Acid Peels


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1064nm Q-switch Laser<br>The 1064 Q-Switch Laser is a medical device that uses a focused laser to remove dark pigment (color) from the skin. | Device: 1064nm Q-switch Laser<br> <br> |
| Active Comparator: Glycolic Acid Peels<br>A Glycolic Acid Chemical Peel is a mild skin treatment used to correct uneven texture and color by removing dead cells from the skin's outermost layer. | Other: Glycolic Acid Peels<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) of Improvement Rated by a Blinded Dermatologist From at 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. | Week 10 |