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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Condition or disease | Intervention/treatment | Phase |
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Melasma | 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 | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Single (Investigator) |
Primary Purpose: | Treatment |
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 Start Date : | January 2008 |
Actual Primary Completion Date : | March 2018 |
Actual Study Completion Date : | March 2018 |

Arm | Intervention/treatment |
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Active Comparator: A
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.
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Drug: 20-30% Salicylic Acid peels 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 right side of the face.
Other Name: Chemical Peels |
Active Comparator: B
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.
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Drug: 20-30% Salicylic Acid peels to the left 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
Other Name: Chemical Peels |
- 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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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00616239
United States, Texas | |
UT Southwestern Medical Center at Dallas - Dermatology Clinical Trials | |
Dallas, Texas, United States, 75390-8802 |
Principal Investigator: | Amit Pandya, M.D. | UT Southwestern Medical Center at Dallas - Department of Dermatology |
Documents provided by Amit Pandya, University of Texas Southwestern Medical Center:
Responsible Party: | Amit Pandya, Professor of Dermatology, University of Texas Southwestern Medical Center |
ClinicalTrials.gov Identifier: | NCT00616239 |
Other Study ID Numbers: |
082007-078 IRB File 082007-078 |
First Posted: | February 15, 2008 Key Record Dates |
Results First Posted: | December 30, 2013 |
Last Update Posted: | August 10, 2020 |
Last Verified: | July 2020 |
Melasma Dark spots on the face |
Melanosis Hyperpigmentation Pigmentation Disorders Skin Diseases Salicylic Acid Salicylates Anti-Infective Agents Antifungal Agents Keratolytic Agents Dermatologic Agents Anti-Inflammatory Agents, Non-Steroidal |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |