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

• 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: University of Texas Southwestern Medical Center
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	20% to 30% Salicylic Acid Peels + 4% Hydroquinone Cream
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

Baseline Characteristics

Arm/Group Title		20% to 30% Salicylic Acid Peels + 4% Hydroquinone Cream
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
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

Outcome Measures

1. Primary Outcome

Title	Number of Participants Showing Improvement of Melasma Based on Mexameter Readings
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	20% to 30% Salicylic Acid Peels + 4% Hydroquinone Cream
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.
Description	[Not Specified]
Time Frame	14 weeks

Outcome Measure Data Not Reported

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	20% to 30% Salicylic Acid Peels + 4% Hydroquinone Cream
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	--/--
Serious Adverse Events
	20% to 30% Salicylic Acid Peels + 4% Hydroquinone Cream
	Affected / at Risk (%)	# Events
Total	0/20 (0.00%)
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

Limitations and Caveats

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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Amit Pandya, M.D.
• Organization: UT Southwestern Medical Center at Dallas
• Phone: 214-645-8300
• EMail: amit.pandya@utsouthwestern.edu

• 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