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

Phase 4

Completed

• Conditions: Melasma
• Interventions: 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

• Registration Number: NCT00616239
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-02-04
• Study First Submitted QC: 2008-02-14
• Study First Posted: 2008-02-15
• Results First Submitted: 2013-08-26
• Results First Submitted QC: 2013-11-08
• Results First Posted: 2013-12-30
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-26
• Last Update Posted: 2020-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	20-30% Salicylic Acid peels to the right side of the face	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.
B	20-30% Salicylic Acid peels to the left side of the face	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Showing Improvement of Melasma Based on Mexameter Readings	14 weeks	Improvement of melasma on the peel side using mexameter reading

Trial Locations

Locations (1)

UT Southwestern Medical Center at Dallas - Dermatology Clinical Trials; 🇺🇸 Dallas, Texas, United States