Salicylic Acid Peels Combined With 4% Hydroquinone in the Treatment of Moderate to Severe Melasma in Hispanic Women
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ClinicalTrials.gov Identifier: NCT00616239 |
Recruitment Status :
Completed
First Posted : February 15, 2008
Results First Posted : December 30, 2013
Last Update Posted : August 10, 2020
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Sponsor:
University of Texas Southwestern Medical Center
Information provided by (Responsible Party):
Amit Pandya, University of Texas Southwestern Medical Center
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Single (Investigator); Primary Purpose: Treatment |
Condition |
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 |
Enrollment | 20 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | 20% to 30% Salicylic Acid Peels + 4% Hydroquinone Cream |
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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. |
Period Title: Overall Study | |
Started | 20 |
Completed | 18 |
Not Completed | 2 |
Reason Not Completed | |
Withdrawal by Subject | 2 |
Baseline Characteristics
Arm/Group Title | 20% to 30% Salicylic Acid Peels + 4% Hydroquinone Cream | |
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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. | |
Overall Number of Baseline Participants | 20 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 20 participants | |
<=18 years |
0 0.0%
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Between 18 and 65 years |
20 100.0%
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>=65 years |
0 0.0%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 20 participants | |
54 (6) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 20 participants | |
Female |
20 100.0%
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Male |
0 0.0%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 20 participants | |
Hispanic or Latino |
20 100.0%
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Not Hispanic or Latino |
0 0.0%
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Unknown or Not Reported |
0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 20 participants | |
American Indian or Alaska Native |
0 0.0%
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Asian |
0 0.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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Black or African American |
0 0.0%
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White |
20 100.0%
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More than one race |
0 0.0%
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Unknown or Not Reported |
0 0.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 20 participants |
20 |
Outcome Measures
Adverse Events
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.
More Information
Results Point of Contact
Name/Title: | Amit Pandya, M.D. |
Organization: | UT Southwestern Medical Center at Dallas |
Phone: | 214-645-8300 |
EMail: | amit.pandya@utsouthwestern.edu |
Responsible Party: | Amit Pandya, University of Texas Southwestern Medical Center |
ClinicalTrials.gov Identifier: | NCT00616239 |
Other Study ID Numbers: |
082007-078 IRB File 082007-078 |
First Submitted: | February 4, 2008 |
First Posted: | February 15, 2008 |
Results First Submitted: | August 26, 2013 |
Results First Posted: | December 30, 2013 |
Last Update Posted: | August 10, 2020 |