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Study of Light Treatment and Laser Treatment for Melasma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Murad Alam, Northwestern University
ClinicalTrials.gov Identifier:
NCT00509977
First received: July 31, 2007
Last updated: September 14, 2012
Last verified: September 2012
History of Changes
  Purpose

The purpose of this study is to determine the efficacy of light treatment and laser treatment for melasma. These treatment options have not been thoroughly explored in the treatment of melasma. By studying the effect of different treatments, a better treatment plan may be developed for people with melasma.


Condition Intervention
Melasma
 Procedure: Light Treatment
Procedure: Laser Treatment

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: A Randomized, Rater-blinded, Split-face Comparison of the Efficacy of Intense Pulse Light vs. Q-switched Nd:Yag Laser for the Treatment of Melasma.

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Melasma Area and Severity Index [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

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

Enrollment: 17
Study Start Date: April 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Light therapy
 Procedure: Light Treatment
Light treatment applied to half of the face at each study visit
Experimental: 2
Laser Treatment
 Procedure: Laser Treatment
Laser treatment applied to half of the face at each study visit

Detailed Description:

The objective of this study is to determine the efficacy of light treatment and laser treatment for melasma. These treatment options have not been thoroughly explored in the treatment of melasma. By studying the effect of different treatments, a better treatment plan may be developed for people with 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: NCT00509977

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

No publications provided by Northwestern University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Murad Alam, Professor in Dermatology, Otolaryngology - Head and Neck Surgery, and Surgery-Organ Transplantation, Northwestern University
ClinicalTrials.gov Identifier: NCT00509977     History of Changes
Other Study ID Numbers: STU706
Study First Received: July 31, 2007
Last Updated: September 14, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases

ClinicalTrials.gov processed this record on May 21, 2013