Study of Light Treatment and Laser Treatment for Melasma

December 1, 2021 updated by: Murad Alam, Northwestern University

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Feinberg School of Medicine, Department of Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Melasma Area and Severity Index
Time Frame: 20 weeks
20 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety
Time Frame: 20 weeks
20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

July 31, 2007

First Submitted That Met QC Criteria

July 31, 2007

First Posted (Estimate)

August 1, 2007

Study Record Updates

Last Update Posted (Actual)

December 3, 2021

Last Update Submitted That Met QC Criteria

December 1, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU706

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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