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Study of Light Treatment and Laser Treatment for Melasma

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ClinicalTrials.gov Identifier: NCT00509977
Recruitment Status : Completed
First Posted : August 1, 2007
Last Update Posted : September 17, 2012
Sponsor:
Information provided by (Responsible Party):
Murad Alam, Northwestern University

Brief Summary:
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 or disease Intervention/treatment Phase
Melasma Procedure: Light Treatment Procedure: Laser Treatment Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (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.
Study Start Date : April 2007
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Melasma Area and Severity Index [ Time Frame: 20 weeks ]

Secondary Outcome Measures :
  1. Safety [ Time Frame: 20 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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): 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

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
First Posted: August 1, 2007    Key Record Dates
Last Update Posted: September 17, 2012
Last Verified: September 2012

Additional relevant MeSH terms:
Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases