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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01976273
First Posted: November 5, 2013
Last Update Posted: July 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Murad Alam, Northwestern University
  Purpose
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.

Condition Intervention
Melanosis Device: 1064nm Q-switch Laser Other: Glycolic Acid Peels

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Murad Alam, Northwestern University:

Primary Outcome Measures:
  • 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.


Enrollment: 20
Study Start Date: October 2013
Study Completion Date: January 7, 2015
Primary Completion Date: January 7, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1064nm Q-switch Laser
The 1064 Q-Switch Laser is a medical device that uses a focused laser to remove dark pigment (color) from the skin.
Device: 1064nm Q-switch Laser
Active Comparator: Glycolic Acid Peels
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.
Other: Glycolic Acid Peels

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01976273


Locations
United States, Illinois
Northwestern University Department of Dermatology
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Murad Alam, MD Northwestern University
  More Information

Responsible Party: Murad Alam, Professor in Dermatology, Otolaryngology - Head and Neck Surgery, and Surgery-Organ Transplantation, Northwestern University
ClinicalTrials.gov Identifier: NCT01976273     History of Changes
Other Study ID Numbers: STU84150
First Submitted: October 15, 2013
First Posted: November 5, 2013
Results First Submitted: May 12, 2017
Results First Posted: June 14, 2017
Last Update Posted: July 24, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases
Glycolic acid
Keratolytic Agents
Dermatologic Agents