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

Not Applicable

Active, not recruiting

• Conditions: Melanosis
• Interventions: Other: Salicylic Acid Peels; Other: Glycolic Acid Peels

• Registration Number: NCT01976286
• Lead Sponsor: Northwestern University

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.

Study Timeline

• Study First Submitted: 2013-10-15
• Study First Submitted QC: 2013-10-29
• Study First Posted: 2013-11-05
• Study Start: 2015-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-14
• Last Update Posted: 2024-03-15
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 21

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Salicylic Acid Peels	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.
Glycolic Acid Peels	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.

Primary Outcome Measures

Name	Time	Method
Change in best overall cosmetic appearance (right side or left side better)rated by a blinded dermatologist from baseline to week 16	1 hour at baseline and week 16	The primary outcome was a blinded rating of the treatment area (Salicylic Acid Peels Versus Glycolic Acid Peels) with the best overall cosmetic appearance. A dermatologist will blindly evaluate the treated areas of each side from live subjects at baseline and on the final follow up visit (week 16).

Trial Locations

Locations (1)

Northwestern University Department of Dermatology; 🇺🇸 Chicago, Illinois, United States