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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 : February 7, 2014
Sponsor:
Information provided by (Responsible Party):
Amit Pandya, University of Texas Southwestern Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Melasma
Interventions 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
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 20% to 30% Salicylic Acid Peels + 4% Hydroquinone Cream
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 20
Completed 18
Not Completed 2
Reason Not Completed
Withdrawal by Subject             2
Arm/Group Title 20% to 30% Salicylic Acid Peels + 4% Hydroquinone Cream
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
<=18 years
0
   0.0%
Between 18 and 65 years
20
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
54  (6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
20
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
1.Primary Outcome
Title Number of Participants Showing Improvement of Melasma Based on Mexameter Readings
Hide Description The degree of participants pigmentation was measured from the affected and unaffected skin on both sides of the face using a narrowband reflectance spectrophotometer.
Time Frame 14 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 20% to 30% Salicylic Acid Peels + 4% Hydroquinone Cream
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: participants
18
2.Secondary Outcome
Title Improvement of Melasma Based on MASI Scores, Melasma Severity Assessment, and Physician and Patient Global Improvement Compared With the Opposite Side.
Hide Description [Not Specified]
Time Frame 14 weeks
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 20% to 30% Salicylic Acid Peels + 4% Hydroquinone Cream
Hide Arm/Group Description 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.
All-Cause Mortality
20% to 30% Salicylic Acid Peels + 4% Hydroquinone Cream
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
20% to 30% Salicylic Acid Peels + 4% Hydroquinone Cream
Affected / at Risk (%) # Events
Total   0/20 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
20% to 30% Salicylic Acid Peels + 4% Hydroquinone Cream
Affected / at Risk (%) # Events
Total   4/20 (20.00%)    
Skin and subcutaneous tissue disorders   
Erythema   4/20 (20.00%)  4
Burning  4/20 (20.00%)  4
Peeling  4/20 (20.00%)  4
Indicates events were collected by systematic assessment
Two subjects did not complete the study were unable to come in for visits because of scheduling difficulties and had no adverse effects at the time of discontinuation.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Amit Pandya, M.D.
Organization: UT Southwestern Medical Center at Dallas
Phone: 214-645-8300
EMail: amit.pandya@utsouthwestern.edu
Layout table for additonal information
Responsible Party: Amit Pandya, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00616239    
Other Study ID Numbers: 082007-078
IRB File 082007-078
First Submitted: February 4, 2008
First Posted: February 15, 2008
Results First Submitted: August 26, 2013
Results First Posted: December 30, 2013
Last Update Posted: February 7, 2014