Salicylic Acid Peels Combined With 4% Hydroquinone in the Treatment of Moderate to Severe Melasma in Hispanic Women
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
2 other identifiers
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jan 2008
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 4, 2008
CompletedFirst Posted
Study publicly available on registry
February 15, 2008
CompletedResults Posted
Study results publicly available
December 30, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedAugust 10, 2020
July 1, 2020
10.2 years
February 4, 2008
August 26, 2013
July 26, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Showing Improvement of Melasma Based on Mexameter Readings
Improvement of melasma on the peel side using mexameter reading
14 weeks
Study Arms (2)
A
ACTIVE COMPARATORSubjects 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
ACTIVE COMPARATORSubjects 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.
Interventions
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.
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
Eligibility Criteria
You may qualify if:
- Hispanic women ages 18-65 years of age with moderate to severe melasma
- English and Spanish-speaking women
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UT Southwestern Medical Center at Dallas - Dermatology Clinical Trials
Dallas, Texas, 75390-8802, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Two subjects did not complete the study were unable to come in for visits because of scheduling difficulties and had no adverse effects at the time of discontinuation.
Results Point of Contact
- Title
- Amit Pandya, M.D.
- Organization
- UT Southwestern Medical Center at Dallas
Study Officials
- PRINCIPAL INVESTIGATOR
Amit Pandya, M.D.
UT Southwestern Medical Center at Dallas - Department of Dermatology
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Dermatology
Study Record Dates
First Submitted
February 4, 2008
First Posted
February 15, 2008
Study Start
January 1, 2008
Primary Completion
March 1, 2018
Study Completion
March 1, 2018
Last Updated
August 10, 2020
Results First Posted
December 30, 2013
Record last verified: 2020-07