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

Melanosis Clinical Trial

Official title:

A Pilot Study Comparing the Efficacy of Glycolic Acid Peels vs. Salicylic Acid Peels for the Treatment of Melasma: A Randomized Control Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01976286
• Other study ID #: STU84250
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2015
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 21
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Melanosis

Intervention

Other:
• Salicylic Acid Peels

• Glycolic Acid Peels

Locations

Country	Name	City	State
United States	Northwestern University Department of Dermatology	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in best overall cosmetic appearance (right side or left side better)rated by a blinded dermatologist from baseline to 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).	1 hour at baseline and week 16