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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Northwestern University
Sponsor:
Information provided by (Responsible Party):
Murad Alam, Northwestern University
ClinicalTrials.gov Identifier:
NCT01976273
First received: October 15, 2013
Last updated: May 22, 2014
Last verified: May 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (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 Northwestern University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    The primary outcome was a blinded rating of the treatment area (1064nm Q-switch Laser Versus Glycolic Acid Peels) with the best overall cosmetic appearance. A dermatologist will blindly evaluate the treated areas of each side from live subjects at baseline and on the final follow up visit (week 10).


Estimated Enrollment: 20
Study Start Date: October 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01976273

Contacts
Contact: Emily Poon, PhD 312-695-4761 research.nuderm@northwestern.edu

Locations
United States, Illinois
Northwestern University Department of Dermatology Recruiting
Chicago, Illinois, United States, 60611
Contact: Emily Poon, PhD    312-695-4761    research.nuderm@norhtwestern.edu   
Principal Investigator: Murad Alam, MD         
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Murad Alam, MD Northwestern University
  More Information

No publications provided

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
Study First Received: October 15, 2013
Last Updated: May 22, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Glycolic acid
Keratolytic Agents
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014