Expired Study
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Dallas, Texas 75390


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.


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


Study is Available At:


Original ID:

082007-078


NCT ID:

NCT00616239


Secondary ID:

IRB File 082007-078


Study Acronym:


Brief Title:

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


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


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Texas Southwestern Medical Center


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

25


Enrollment Type:

Actual


Overall Contact Information

Official Name:Amit Pandya, M.D.
Principal Investigator
UT Southwestern Medical Center at Dallas - Department of Dermatology

Study Dates

Start Date:January 2008
Completion Date:June 2008
Completion Type:Actual
Primary Completion Date:June 2008
Primary Completion Type:Actual
Verification Date:September 2012
Last Changed Date:September 18, 2012
First Received Date:February 4, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure: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
Safety Issues:True
Outcome Type:Primary Outcome
Measure:Improvement of melasma based on mexameter readings.
Time Frame:14 weeks
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:20-30% Salicylic Acid peels to the right side of t
Description: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.
Arm Name:A
Other Name:Chemical Peels
Intervention Type:Drug
Name:20-30% Salicylic Acid peels to the left side of th
Description: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
Arm Name:B
Other Name:Chemical Peels

Study Arms

Study Arm Type:Active Comparator
Arm Name:A
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.
Study Arm Type:Active Comparator
Arm Name:B
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Texas Southwestern Medical Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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