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Salicylic Acid Peels Combined With 4% Hydroquinone in the Treatment of Moderate to Severe Melasma in Hispanic Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00616239
Recruitment Status : Completed
First Posted : February 15, 2008
Results First Posted : December 30, 2013
Last Update Posted : August 10, 2020
Sponsor:
Information provided by (Responsible Party):
Amit Pandya, University of Texas Southwestern Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
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 Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 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.
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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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
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Texas
UT Southwestern Medical Center at Dallas - Dermatology Clinical Trials
Dallas, Texas, United States, 75390-8802
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Amit Pandya, M.D. UT Southwestern Medical Center at Dallas - Department of Dermatology
  Study Documents (Full-Text)

Documents provided by Amit Pandya, University of Texas Southwestern Medical Center:
Study Protocol and Statistical Analysis Plan  [PDF] October 6, 2006

More Information
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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
Keywords provided by Amit Pandya, University of Texas Southwestern Medical Center:
Melasma
Dark spots on the face
Additional relevant MeSH terms:
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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