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

Primary Purpose

Melasma

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

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

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

About this trial

This is an interventional treatment trial for Melasma focused on measuring Melasma, Dark spots on the face

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

UT Southwestern Medical Center at Dallas - Dermatology Clinical Trials

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm 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.

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.

Outcomes

Primary Outcome Measures

Number of Participants Showing Improvement of Melasma Based on Mexameter Readings

Improvement of melasma on the peel side using mexameter reading

Secondary Outcome Measures

Full Information

NCT ID

NCT00616239

First Posted

February 4, 2008

Last Updated

July 26, 2020

Sponsor

University of Texas Southwestern Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00616239

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

January 2008 (undefined)

Primary Completion Date

March 2018 (Actual)

Study Completion Date

March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Texas Southwestern Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Melasma

Keywords

Melasma, Dark spots on the face

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Arm Title

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

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

Other Intervention Name(s)

Chemical Peels

Intervention 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.

Intervention Type

Drug

Intervention Name(s)

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

Other Intervention Name(s)

Chemical Peels

Intervention 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

Primary Outcome Measure Information:

Title

Number of Participants Showing Improvement of Melasma Based on Mexameter Readings

Description

Improvement of melasma on the peel side using mexameter reading

Time Frame

14 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amit Pandya, M.D.

Organizational Affiliation

UT Southwestern Medical Center at Dallas - Department of Dermatology

Official's Role

Principal Investigator

Facility Information:

Facility Name

UT Southwestern Medical Center at Dallas - Dermatology Clinical Trials

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390-8802

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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