Treatment of Melasma With Glycolic Acid-Salicylic Acid Peel Versus Glycolic Acid Peel

• Status: Withdrawn
• Trial end date: 2019-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this pilot study is to conduct a controlled comparison of the efficacy and safety of a combination peel (glycolic acid and salicylic acid) as compared to glycolic acid peel alone in the treatment of melasma. Our primary outcome is objective improvement in pigmentation as evaluated using a colorimeter. Our secondary outcomes are subjective improvement using the Melasma Area and Severity Index (MASI) and Patient and Physician Global assessment, as well as assessment of treatment tolerability and patient satisfaction.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boston Medical Center
• Treatments: Glycolic acid; Salicylates; Salicylic Acid

Criteria

Inclusion Criteria:

• Female and males aged 18 or older

• Subjects with melasma on both sides of the face (forehead or cheek).

• Subjects in general good health

• Female of childbearing age will be on a reliable form of contraception during the course of treatment other than oral contraceptive pills or hormonal intrauterine device.

• Subjects must be willing to sign consent, answer questionnaires, comply with all clinical visits, and use sunscreen and sun-protection.

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

Exclusion Criteria:

• Subjects suffering from other pigmentation disorders.

• Subjects with known allergy to any components of the peels

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

• Pregnant women, nursing mothers.

• Subjects with history of abnormal scaring

• Subjects who cannot communicate with investigators or who are unlikely to cooperate.

• Subjects in a situation in which in the opinion of the investigators, may interfere with optimal participation in the study.

• Subjects who have used chemical peels, microdermabrasion or facial laser treatments in the past 3 months.