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

NCT ID: NCT00616239

Last Updated: 2020-08-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2018-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Melasma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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A

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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.

B

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

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

Intervention Type DRUG

Other Intervention Names

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Chemical Peels Chemical Peels

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Amit Pandya

Professor of Dermatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amit Pandya, M.D.

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center at Dallas - Department of Dermatology

Locations

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UT Southwestern Medical Center at Dallas - Dermatology Clinical Trials

Dallas, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IRB File 082007-078

Identifier Type: -

Identifier Source: secondary_id

082007-078

Identifier Type: -

Identifier Source: org_study_id

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