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Study of Acid Peel and Laser for the Treatment of Melasma
This study is currently recruiting participants.
Verified by Northwestern University, October 2008
Sponsored by: Northwestern University
Information provided by: Northwestern University
ClinicalTrials.gov Identifier: NCT00467233
  Purpose

The objective of this study is to evaluate laser treatment and acid peel for the treatment of melasma.


Condition Intervention
Melasma
Procedure: Laser Treatment
Procedure: Acid Peel

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title: Study of Acid Peel and Laser for the Treatment of Melasma

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • MASI [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Time Frame: 20 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: May 2007
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Laser Treatment
Procedure: Laser Treatment
Laser treatment to half of the face at each study visit
2: Experimental
Acid peel
Procedure: Acid Peel
Acid peel to half of the face at each study visit

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00467233

Contacts
Contact: Natalie Kim 312 695 6785 nkim@northwestern.edu

Locations
United States, Illinois
Northwestern University Dermatology Department Recruiting
Chicago, Illinois, United States, 60611
Principal Investigator: Murad Alam, MD            
Sub-Investigator: Alfred Rademaker, PhD            
Sub-Investigator: Mary Martini, MD            
Sub-Investigator: Natalie Kim            
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Murad Alam, MD Northwestern University
  More Information

Responsible Party: Murad Alam, MD ( Northwestern University )
Study ID Numbers: MA-123456-DD
Study First Received: April 26, 2007
Last Updated: October 2, 2008
ClinicalTrials.gov Identifier: NCT00467233  
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Hyperpigmentation
Skin Diseases
Pigmentation Disorders
Melanosis

ClinicalTrials.gov processed this record on January 15, 2009