A Pilot Study Testing Salicylic Acid Peels 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 Glycolic Acid Chemical Peels compared to Salicylic Acid Chemical Peels for the treatment of melasma.

Detailed Description
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Participants in this study will be patients who are clinically diagnosed with at least a 2 x 2 cm patch of melasma on each side of their face (forehead or cheek). One half of the subject's face will be randomly selected to receive 4 treatments of 30% glycolic acid peels and the other half of the face will receive 4 treatments of 30% salicylic acid peels/ weeks 0, 4, 8, and 12. Follow up visit will be at week 16. 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 Glycolic Acid Peels vs. Salicylic Acid Peels for the Treatment of Melasma: A Randomized Control Trial

Conditions
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Melanosis

Intervention / Treatment
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* Other: Salicylic Acid Peels
* 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

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: Salicylic Acid Peels<br>Salicylic Acid and Glycolic Acid Chemical Peels are skin treatments used to correct uneven texture and color by removing dead cells from the skin's top layer. | Other: Salicylic Acid Peels<br> <br> |
| Active Comparator: Glycolic Acid Peels<br>Salicylic Acid and Glycolic Acid Chemical Peels are skin treatments used to correct uneven texture and color by removing dead cells from the skin's top 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 |
| --- | --- | --- |
| Change in best overall cosmetic appearance (right side or left side better)rated by a blinded dermatologist from baseline to week 16 | The primary outcome was a blinded rating of the treatment area (Salicylic Acid Peels Versus Glycolic Acid Peels) with the best overall cosmetic appearance. A dermatologist will blindly evaluate the treated areas of each side from live subjects at baseline and on the final follow up visit (week 16). | 1 hour at baseline and week 16 |