Study of Light Treatment and Laser Treatment for Melasma - Full Text View

Sponsor:	Northwestern University
Information provided by:	Northwestern University
ClinicalTrials.gov Identifier:	NCT00509977

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:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Study of Light Treatment and Laser Treatment for 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 ]

Estimated Enrollment:	20
Study Start Date:	April 2007
Estimated Study Completion Date:	June 2010
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Light therapy	Procedure: Light Treatment Light treatment applied to half of the face at each study visit
2: Experimental 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 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:	Murad Alam, MD ( Northwestern University )
Study ID Numbers:	MA-12345-DD
Study First Received:	July 31, 2007
Last Updated:	August 4, 2009
ClinicalTrials.gov Identifier:	NCT00509977 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Hyperpigmentation
Skin Diseases
Pigmentation Disorders
Melanosis

ClinicalTrials.gov processed this record on November 09, 2009