Skip to main content
OpenTrials
Completed

NCT Number: NCT01976273

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Melanosis Hyperpigmentation Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University Department of Dermatology

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects aged 18 years or older
  • Subjects with at least a 2 x 2 cm patch of melasma on each side of the face (forehead or cheek)
  • Subjects in general good health
  • Subjects must be willing and able to understand and provide informed consent for the use of their tissue and communicate with the investigator
  • Subjects must be willing to not apply other treatment options for melasma during the course of the study

Exclusion criteria

  • Subjects under 18 years of age
  • Subjects who are pregnant and/or lactating
  • Subjects who are unable to understand the protocol or to give informed consent
  • Subjects diagnosed with mental illness
  • Subjects who have concurrent active uncontrolled disease to facial area (i.e uncontrolled acne)
  • Subjects who have had a chemical peel in the past 3 months
  • Subjects who have used a prescribed retinoid in the past 3 months
  • Subjects with a bleeding disorder
  • Subjects with a history of abnormal wound healing
  • Subjects with a history of abnormal scarring
  • Subjects who report being allergic to glycolic acid

Treatment and study plan

1064nm Q-switch Laser

Device

Glycolic Acid Peels

Other

Primary outcomes

  1. Visual Analog Scale (VAS) of Improvement Rated by a Blinded Dermatologist From at Week 10

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 5, 2013
Registry last updated
Dec 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.