- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01976286
A Pilot Study Testing Salicylic Acid Peels Versus Glycolic Acid Peels for the Treatment of Melasma
January 29, 2025 updated by: Murad Alam, Northwestern University
A Pilot Study Comparing the Efficacy of Glycolic Acid Peels Vs. Salicylic 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 Glycolic Acid Chemical Peels compared to Salicylic Acid Chemical Peels for the treatment of melasma.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Participants in this study will be patients who are clinically diagnosed with at least a 2 x 2 cm patch of melasma on each side of their face (forehead or cheek).
One half of the subject's face will be randomly selected to receive 4 treatments of 30% glycolic acid peels and the other half of the face will receive 4 treatments of 30% salicylic acid peels/ weeks 0, 4, 8, and 12. Follow up visit will be at week 16.
This study is a pilot study designed to determine feasibility of these procedures.
Study Type
Interventional
Enrollment (Actual)
21
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
-
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Illinois
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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
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
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 |
|---|---|
|
Active Comparator: Salicylic Acid Peels
Salicylic Acid and Glycolic Acid Chemical Peels are skin treatments used to correct uneven texture and color by removing dead cells from the skin's top layer.
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Active Comparator: Glycolic Acid Peels
Salicylic Acid and Glycolic Acid Chemical Peels are skin treatments used to correct uneven texture and color by removing dead cells from the skin's top layer.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in best overall cosmetic appearance (right side or left side better)rated by a blinded dermatologist from baseline to week 16
Time Frame: 1 hour at baseline and week 16
|
The primary outcome was a blinded rating of the treatment area (Salicylic Acid Peels 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 16).
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1 hour at baseline and week 16
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Murad Alam, MD, Northwestern University
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
January 1, 2015
Primary Completion (Estimated)
December 1, 2025
Study Completion (Estimated)
December 1, 2025
Study Registration Dates
First Submitted
October 15, 2013
First Submitted That Met QC Criteria
October 29, 2013
First Posted (Estimated)
November 5, 2013
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 29, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Pigmentation Disorders
- Hyperpigmentation
- Melanosis
- Anti-Infective Agents
- Antifungal Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Inflammatory Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Antirheumatic Agents
- Dermatologic Agents
- Sensory System Agents
- Analgesics, Non-Narcotic
- Analgesics
- Anti-Inflammatory Agents, Non-Steroidal
- Cyclooxygenase Inhibitors
- Keratolytic Agents
- Salicylic Acid
- Glycolic acid
- Salicylates
Other Study ID Numbers
- STU84250
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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