- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01976273
A Pilot Study Testing 1064nm Q-switch Laser Versus Glycolic Acid Peels for the Treatment of Melasma
December 2, 2021 updated by: Murad Alam, Northwestern University
A Pilot Study Comparing the Efficacy of 1064 Q-switch Laser vs. Glycolic Acid Peels for the Treatment of Melasma: A Randomized Control Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern University Department of Dermatology
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Week 10
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2013
Primary Completion (ACTUAL)
January 7, 2015
Study Completion (ACTUAL)
January 7, 2015
Study Registration Dates
First Submitted
October 15, 2013
First Submitted That Met QC Criteria
October 29, 2013
First Posted (ESTIMATE)
November 5, 2013
Study Record Updates
Last Update Posted (ACTUAL)
December 6, 2021
Last Update Submitted That Met QC Criteria
December 2, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU84150
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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