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Salicylic Acid Peels Combined With 4% Hydroquinone in the Treatment of Moderate to Severe Melasma in Hispanic Women
This study has been completed.

First Received on February 4, 2008.   Last Updated on January 21, 2009   History of Changes
Sponsor: University of Texas Southwestern Medical Center
Information provided by: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00616239
  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 IV

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:

Drug Information available for: Salicylic acid 1,4-Benzenediol
U.S. FDA Resources

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

Primary Outcome Measures:
  • Improvement of melasma based on mexameter readings. [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

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: 25
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, M.D., UT Southwestern Medical Center at Dallas - Department of Dermatology
ClinicalTrials.gov Identifier: NCT00616239     History of Changes
Other Study ID Numbers: 082007-078, IRB File 082007-078
Study First Received: February 4, 2008
Last Updated: January 21, 2009
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
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

ClinicalTrials.gov processed this record on February 09, 2012



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