Salicylic Acid Peels Combined With 4% Hydroquinone in the Treatment of Moderate to Severe Melasma in Hispanic Women
Information source: University of Texas Southwestern Medical Center
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Melasma
Intervention: 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 (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: University of Texas Southwestern Medical Center Official(s) and/or principal investigator(s):
Amit Pandya, M.D., Principal Investigator, Affiliation: UT Southwestern Medical Center at Dallas - Department of Dermatology
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.
Clinical Details
Official title: 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 design: Treatment, Randomized, Single Blind (Investigator), Active Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Improvement of melasma based on mexameter readings.
Secondary outcome: Improvement of melasma based on MASI scores, melasma severity assessment, and physician and patient global improvement compared with the opposite side.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
UT Southwestern Medical Center at Dallas - Dermatology Clinical Trials, Dallas, Texas 75390-8802, United States
Additional Information
Starting date: January 2008
Ending date: June 2008
Last updated: April 28, 2008
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