A Pilot Study Testing 1064nm Q-switch Laser Versus Glycolic Acid Peels for the Treatment of Melasma
This trial is active, not recruiting.
|Treatments||1064nm q-switch laser, glycolic acid peels|
|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.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
|Masking||single blind (outcomes assessor)|
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
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
|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.|
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