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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Tracking Information | ||||
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First Submitted Date ICMJE | February 4, 2008 | |||
First Posted Date ICMJE | February 15, 2008 | |||
Results First Submitted Date ICMJE | August 26, 2013 | |||
Results First Posted Date ICMJE | December 30, 2013 | |||
Last Update Posted Date | August 10, 2020 | |||
Study Start Date ICMJE | January 2008 | |||
Actual Primary Completion Date | March 2018 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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
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Original Primary Outcome Measures ICMJE |
Improvement of Melasma Based on Mexameter Readings. [ Time Frame: 14 weeks ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE |
Improvement of Melasma Based on MASI Scores, Melasma Severity Assessment, and Physician and Patient Global Improvement Compared With the Opposite Side. [ Time Frame: 14 weeks ] | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Salicylic Acid Peels Combined With 4% Hydroquinone in the Treatment of Moderate to Severe Melasma in Hispanic Women | |||
Official Title ICMJE | 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 | |||
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 Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Single (Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Melasma | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
20 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | March 2018 | |||
Actual Primary Completion Date | March 2018 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00616239 | |||
Other Study ID Numbers ICMJE | 082007-078 IRB File 082007-078 |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Amit Pandya, University of Texas Southwestern Medical Center | |||
Study Sponsor ICMJE | University of Texas Southwestern Medical Center | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | University of Texas Southwestern Medical Center | |||
Verification Date | July 2020 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |