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

The University of Texas System (UT)

Status and phase: Completed; Phase 4

Conditions: Melasma

Treatments: 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

Study type: Interventional

Funder types: Other

Identifiers

NCT00616239

IRB File 082007-078

082007-078

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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20 participants in 2 patient groups

A

Active Comparator 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.

Treatment:

Drug: 20-30% Salicylic Acid peels to the right side of the face

B

Active Comparator group

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.

Treatment:

Drug: 20-30% Salicylic Acid peels to the left side of the face