Study of Light Treatment and Laser Treatment for Melasma

Sponsor

Northwestern University (Other)

Overall Status

Completed

CT.gov ID

NCT00509977

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

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 :

Apr 1, 2007

Actual Primary Completion Date :

Sep 1, 2009

Actual Study Completion Date :

Sep 1, 2009

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Melasma Area and Severity Index [20 weeks]

Secondary Outcome Measures

Safety [20 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Murad Alam, Professor in Dermatology, Otolaryngology - Head and Neck Surgery, and Surgery-Organ Transplantation, Northwestern University

ClinicalTrials.gov Identifier:

NCT00509977

Other Study ID Numbers:

STU706

First Posted:

Aug 1, 2007

Last Update Posted:

Dec 3, 2021

Last Verified:

Dec 1, 2021

Additional relevant MeSH terms:

Melanosis

Study Results

No Results Posted as of Dec 3, 2021