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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amit Pandya, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00616239
First received: February 4, 2008
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

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 Intervention 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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Number of Participants Showing Improvement of Melasma Based on Mexameter Readings [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
    The degree of participants pigmentation was measured from the affected and unaffected skin on both sides of the face using a narrowband reflectance spectrophotometer.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: January 2008
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00616239

Locations
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
Principal Investigator: Amit Pandya, M.D. UT Southwestern Medical Center at Dallas - Department of Dermatology
  More Information

No publications provided

Responsible Party: Amit Pandya, Professor of Dermatology, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00616239     History of Changes
Other Study ID Numbers: 082007-078, IRB File 082007-078
Study First Received: February 4, 2008
Results First Received: August 26, 2013
Last Updated: January 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
Melasma
Dark spots on the face

Additional relevant MeSH terms:
Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases
Hydroquinone
Salicylic Acid
Salicylates
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents
Therapeutic Uses
Antifungal Agents
Keratolytic Agents
Dermatologic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 15, 2014