This trial is active, not recruiting.

Condition melanosis
Treatments 1064nm q-switch laser, glycolic acid peels
Sponsor Northwestern University
Start date October 2013
End date March 2017
Trial size 20 participants
Trial identifier NCT01976273, STU84150


The purpose of this study is to find out the safety and effectiveness of 1064 Q-Switch Laser Therapy compared to Glycolic Acid Chemical Peels for the treatment of melasma.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
(Active Comparator)
The 1064 Q-Switch Laser is a medical device that uses a focused laser to remove dark pigment (color) from the skin.
1064nm q-switch laser
(Active Comparator)
A Glycolic Acid Chemical Peel is a mild skin treatment used to correct uneven texture and color by removing dead cells from the skin's outermost layer.
glycolic acid peels

Primary Outcomes

Change in best overall cosmetic appearance (right side or left side better)rated by a blinded dermatologist from baseline to week 10
time frame: 1 hour at baseline and week 10

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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 11. Subjects who report being allergic to glycolic acid

Additional Information

Official title A Pilot Study Comparing the Efficacy of 1064 Q-switch Laser vs. Glycolic Acid Peels for the Treatment of Melasma: A Randomized Control Trial
Principal investigator Murad Alam, MD
Description Participants in this study will be patients at the dermatology clinic who are clinically diagnosed with at least a 2X2 cm patch of melasma on each side of their face (forehead or cheek). Starting at 2 weeks before treatment (week 2), both sides will be pretreated and primed with 4% hydroquinone with, if necessary, 2.5% hydrocortisone cream BID. On the treatment day (2-weeks) and 6-weeks one half of the subject's face will receive glycolic acid peels and the other half of the face will receive 1064nm Q-switch laser. This study is a pilot study designed to determine feasibility of these procedures.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Northwestern University.