A Pilot Study Testing Salicylic Acid Peels Versus Glycolic Acid Peels for the Treatment of Melasma

NCT ID: NCT01976286

Last Updated: 2025-01-31

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2025-12-31

Brief Summary

The purpose of this study is to find out the safety and effectiveness of Glycolic Acid Chemical Peels compared to Salicylic Acid Chemical Peels for the treatment of melasma.

Detailed Description

Participants in this study will be patients who are clinically diagnosed with at least a 2 x 2 cm patch of melasma on each side of their face (forehead or cheek). One half of the subject's face will be randomly selected to receive 4 treatments of 30% glycolic acid peels and the other half of the face will receive 4 treatments of 30% salicylic acid peels/ weeks 0, 4, 8, and 12. Follow up visit will be at week 16. This study is a pilot study designed to determine feasibility of these procedures.

Conditions

Melanosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Salicylic Acid Peels

Salicylic Acid and Glycolic Acid Chemical Peels are skin treatments used to correct uneven texture and color by removing dead cells from the skin's top layer.

Group Type: ACTIVE_COMPARATOR

Salicylic Acid Peels

Intervention Type: OTHER

Glycolic Acid Peels

Salicylic Acid and Glycolic Acid Chemical Peels are skin treatments used to correct uneven texture and color by removing dead cells from the skin's top layer.

Group Type: ACTIVE_COMPARATOR

Glycolic Acid Peels

Intervention Type: OTHER

Interventions

Salicylic Acid Peels

Intervention Type: OTHER

Glycolic Acid Peels

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Subjects aged 18 years or older

2. Subjects with at least a 2 x 2 cm patch of melasma on each side of the face (forehead or cheek)

3. Subjects in general good health

4. Subjects must be willing and able to understand and provide informed consent for the use of their tissue and communicate with the investigator

5. Subjects must be willing to not apply other treatment options for melasma during the course of the study

Exclusion Criteria

1. Subjects under 18 years of age

2. Subjects who are pregnant and/or lactating

3. Subjects who are unable to understand the protocol or to give informed consent

4. Subjects diagnosed with mental illness

5. Subjects who have concurrent active uncontrolled disease to facial area (i.e uncontrolled acne)

6. Subjects who have had a chemical peel in the past 3 months

7. Subjects who have used a prescribed retinoid in the past 3 months

8. Subjects with a bleeding disorder

9. Subjects with a history of abnormal wound healing

10. Subjects with a history of abnormal scarring

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Murad Alam

Professor in Dermatology, Otolaryngology - Head and Neck Surgery, and Surgery-Organ Transplantation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Murad Alam, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University Department of Dermatology

Chicago, Illinois, United States

Countries

United States

Other Identifiers

STU84250

Identifier Type: -

Identifier Source: org_study_id