A Pilot Study Testing 1064nm Q-switch Laser Versus Glycolic Acid Peels for the Treatment of Melasma

Melanosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01976273
• Other study ID #: STU84150
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Est. completion date: January 7, 2015

Study information

• Verified date: December 2021
• 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 1064 Q-Switch Laser Therapy compared to Glycolic Acid Chemical Peels for the treatment of melasma.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 7, 2015
• Est. primary completion date: January 7, 2015
• 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

11. Subjects who report being allergic to glycolic acid

Related Conditions & MeSH terms

• Melanosis

Intervention

Device:
• 1064nm Q-switch Laser

Other:
• 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	Visual Analog Scale (VAS) of Improvement Rated by a Blinded Dermatologist From at Week 10	The primary outcome was a blinded rating of improvement of the treatment area (1064nm Q-switch Laser Versus Glycolic Acid Peels) using a Visual Analog Scale (VAS). A dermatologist blindly evaluated the treated areas of each side from live subjects at baseline on the final follow up visit (week 10). The VAS of improvement was rated on a scale of 0 to10, with 0 being no improvement and 10 being the most improvement seen by the treatment.	Week 10