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

Overview

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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: March 2018

Interventions

  • 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

Primary 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

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • 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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