Salicylic Acid Peels Combined With 4% Hydroquinone in the Treatment of Moderate to Severe Melasma in Hispanic Women

Study Overview
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Brief Summary
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This study will enroll 20 adult Hispanic women. Participants will apply 4% hydroquinone cream twice daily to affected areas on the face for 14 weeks and half the face will be peeled with 20-30% salicylic acid every two weeks for a total of 4 peels. The first two peels will be 20% salicylic acid and the second two peels will be with 30% salicylic acid. The purpose of the study will be to evaluate the safety and efficacy of salicylic acid combined with 4% hydroquinone versus 4% hydroquinone alone.

Official Title
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The Efficacy of Salicylic Acid Peels Combined With 4% Hydroquinone Cream Versus 4% Hydroquinone Cream Alone in the Treatment of Hispanic Women With Moderate to Severe Melasma

Conditions
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Melasma

Intervention / Treatment
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* Drug: 20-30% Salicylic Acid peels to the right side of the face
* Drug: 20-30% Salicylic Acid peels to the left side of the face


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hispanic women ages 18-65 years of age with moderate to severe melasma English and Spanish-speaking women Exclusion Criteria: Pregnant or breast-feeding women Subjects who have used 4% hydroquinone within 3 months of study start Subjects who have used chemical peels, microdermabrasion or facial laser treatments within 9 months of study start

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

Sexes Eligible for Study
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Female

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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Subjects randomized to have the right side of the face peeled with salicylic acid every 2 weeks for a total of 4 peels (first 2 at 20% and last 2 at 30%). Subjects will apply 4% hydroquinone cream to affected areas on entire face for 14 weeks. | Drug: 20-30% Salicylic Acid peels to the right side of the face<br>* Two 20% salicylic acid peels two weeks apart followed by 2 30% salicylic acid peels two weeks apart to the right side of the face.<br>* Other names: Chemical Peels;|
| Active Comparator: B<br>Subjects randomized to have the left side of the face peeled with salicylic acid every 2 weeks for a total of 4 peels (first 2 at 20% and last 2 at 30%). Subjects will apply 4% hydroquinone cream to affected areas on entire face for 14 weeks. | Drug: 20-30% Salicylic Acid peels to the left side of the face<br>* Two 20% salicylic acid peels two weeks apart followed by 2 30% salicylic acid peels two weeks apart to the left side of the face<br>* Other names: Chemical Peels;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Showing Improvement of Melasma Based on Mexameter Readings | Improvement of melasma on the peel side using mexameter reading | 14 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Melasma, Dark spots on the face