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Study of Acid Peel and Laser for the Treatment of Melasma
This study has been completed.

First Received on April 26, 2007.   Last Updated on June 1, 2011   History of Changes
Sponsor: 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Laser Treatment
Procedure: Laser Treatment
Laser treatment to half of the face at each study visit
Experimental: 2
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

Locations
United States, Illinois
Northwestern University Dermatology Department
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Murad Alam, MD Northwestern University
  More Information

No publications provided

Responsible Party: Northwestern University, Murad Alam, MD
ClinicalTrials.gov Identifier: NCT00467233     History of Changes
Other Study ID Numbers: MA-123456-DD
Study First Received: April 26, 2007
Last Updated: June 1, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases

ClinicalTrials.gov processed this record on February 12, 2012