- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00467233
Study of Acid Peel and Laser for the Treatment of Melasma
November 30, 2021 updated by: Murad Alam, Northwestern University
A Randomized, Rater-blinded, Split-face Comparison of the Efficacy of 30 % Salicylic Acid Peel vs. Q-switched Nd:Yag Laser for the Treatment of Melasma.
The objective of this study is to evaluate laser treatment and acid peel for the treatment of melasma.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to evaluate the safety and efficacy of laser treatment and acid peel for the treatment of melasma.
Study Type
Interventional
Enrollment (Actual)
15
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 Feinberg School of Medicine, Department of Dermatology
-
-
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 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of melasma lesion measuring at least 4 square centimeters.
- Age 18-75 years.
- Good health.
- Willingness and ability to understand and provide informed consent for participation in the study.
- Ability to communicate with the investigator.
- Must be willing to forgo other treatment options for melasma during the course of the study.
Exclusion Criteria:
- Inability to understand the protocol or to give informed consent.
- Mental illness.
- Under 18 years of age and over 75 years of age.
- Laser treatment in the last 6 months before enrollment.
- Isotretinoin within the past year.
- Lidocaine allergy.
- History of herpes simplex viral infection.
- Concurrent active disease to facial area (i.e acne).
- Bleeding disorder.
- History of abnormal wound healing.
- History of abnormal scarring.
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 Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
Laser Treatment
|
Laser treatment to half of the face at each study visit
|
|
Experimental: 2
Acid peel
|
Acid peel to half of the face at each study visit
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
MASI
Time Frame: 20 weeks
|
20 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Safety
Time Frame: 20 weeks
|
20 weeks
|
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
May 1, 2007
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
April 26, 2007
First Submitted That Met QC Criteria
April 26, 2007
First Posted (Estimate)
April 30, 2007
Study Record Updates
Last Update Posted (Actual)
December 2, 2021
Last Update Submitted That Met QC Criteria
November 30, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU679
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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