search
Back to results

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

Primary Purpose

Melanosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
1064nm Q-switch Laser
Glycolic Acid Peels
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Northwestern University Department of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1064nm Q-switch Laser

Glycolic Acid Peels

Arm Description

The 1064 Q-Switch Laser is a medical device that uses a focused laser to remove dark pigment (color) from the skin.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 15, 2013
Last Updated
December 2, 2021
Sponsor
Northwestern University
search

1. Study Identification

Unique Protocol Identification Number
NCT01976273
Brief Title
A Pilot Study Testing 1064nm Q-switch Laser Versus Glycolic Acid Peels for the Treatment of Melasma
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
January 7, 2015 (Actual)
Study Completion Date
January 7, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1064nm Q-switch Laser
Arm Type
Active Comparator
Arm Description
The 1064 Q-Switch Laser is a medical device that uses a focused laser to remove dark pigment (color) from the skin.
Arm Title
Glycolic Acid Peels
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
1064nm Q-switch Laser
Intervention Type
Other
Intervention Name(s)
Glycolic Acid Peels
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS) of Improvement Rated by a Blinded Dermatologist From at Week 10
Description
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.
Time Frame
Week 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murad Alam, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University Department of Dermatology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs