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A Pilot Study Testing Salicylic Acid Peels Versus Glycolic Acid Peels for the Treatment of Melasma

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.
ClinicalTrials.gov Identifier: NCT01976286
Recruitment Status : Active, not recruiting
First Posted : November 5, 2013
Last Update Posted : October 18, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Melanosis Other: Salicylic Acid Peels Other: Glycolic Acid Peels

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Study Comparing the Efficacy of Glycolic Acid Peels vs. Salicylic Acid Peels for the Treatment of Melasma: A Randomized Control Trial
Study Start Date : January 2015
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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.
Other: Salicylic Acid Peels
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.
Other: Glycolic Acid Peels


Outcome Measures

Primary Outcome Measures :
  1. 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).


Eligibility Criteria

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
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): NCT01976286


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: NCT01976286     History of Changes
Other Study ID Numbers: STU84250
First Posted: November 5, 2013    Key Record Dates
Last Update Posted: October 18, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases
Salicylic Acid
Glycolic acid
Salicylates
Anti-Infective Agents
Antifungal Agents
Keratolytic Agents
Dermatologic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action