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

Sponsored by:	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

Drug Information available for: 1,4-Benzenediol Salicylic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Active Control, Single Group Assignment, Safety/Efficacy Study
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

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 ]

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

Arms	Assigned Interventions
A: Active Comparator 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.
B: Active Comparator 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

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

Responsible Party:	UT Southwestern Medical Center at Dallas - Department of Dermatology ( Amit Pandya, M.D. )
Study ID Numbers:	082007-078, IRB File 082007-078
Study First Received:	February 4, 2008
Last Updated:	April 28, 2008
ClinicalTrials.gov Identifier:	NCT00616239
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:

Melasma
Dark spots on the face

Study placed in the following topic categories:

Hyperpigmentation
Skin Diseases
Facies
Clotrimazole
Miconazole

Pigmentation Disorders
Hydroquinone
Tioconazole
Salicylic Acid
Melanosis

Additional relevant MeSH terms:

Keratolytic Agents
Anti-Infective Agents
Radiation-Protective Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Antifungal Agents

Therapeutic Uses
Physiological Effects of Drugs
Dermatologic Agents
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009