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.
Full Title of Study: “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”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: Single (Investigator)
- Study Primary Completion Date: March 2018
- Drug: 20-30% Salicylic Acid peels to the right side of the face
- 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.
- Drug: 20-30% Salicylic Acid peels to the left side of the face
- 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
Arms, Groups and Cohorts
- Active Comparator: A
- 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.
- Active Comparator: B
- 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.
Clinical Trial Outcome Measures
- Number of Participants Showing Improvement of Melasma Based on Mexameter Readings
- Time Frame: 14 weeks
- Improvement of melasma on the peel side using mexameter reading
Participating in This Clinical Trial
- Hispanic women ages 18-65 years of age with moderate to severe melasma
- English and Spanish-speaking women
- 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
Gender Eligibility: Female
Minimum Age: 18 Years
Maximum Age: 65 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- University of Texas Southwestern Medical Center
- Provider of Information About this Clinical Study
- Principal Investigator: Amit Pandya, Professor of Dermatology – University of Texas Southwestern Medical Center
- Overall Official(s)
- Amit Pandya, M.D., Principal Investigator, UT Southwestern Medical Center at Dallas – Department of Dermatology
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