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

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:

Drug Information available for: Salicylic acid Hydroquinone

U.S. FDA Resources

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:


Hydroquinone Salicylates Salicylic Acid Analgesics Analgesics, Non-Narcotic Anti-Infective Agents Anti-Inflammatory Agents Anti-Inflammatory Agents, Non-Steroidal Antifungal Agents Antioxidants Antirheumatic Agents Central Nervous System Agents	Cyclooxygenase Inhibitors Dermatologic Agents Enzyme Inhibitors Keratolytic Agents Molecular Mechanisms of Pharmacological Action Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Protective Agents Radiation-Protective Agents Sensory System Agents Therapeutic Uses

ClinicalTrials.gov processed this record on March 02, 2015