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

Melasma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00616239
• Other study ID #: 082007-078
• Secondary ID: IRB File 082007-
• Status: Completed
• Phase: Phase 4
• Start date: January 2008
• Est. completion date: March 2018

Study information

• Verified date: July 2020
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Melanosis
• Melasma

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center at Dallas - Dermatology Clinical Trials	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Showing Improvement of Melasma Based on Mexameter Readings	Improvement of melasma on the peel side using mexameter reading	14 weeks