Condition(s) treated: Melasma

Intervention: Light Treatment (Procedure); Laser Treatment (Procedure)

Enrollment status: Recruiting

Sponsor: Northwestern University

Principal investigator(s) or official(s):
Murad Alam, MD, Principal Investigator, Affiliation: Northwestern University

Overall contact:
Joslyn Witherspoon, MD, MPH, Phone: 312 695 0281, Email: j-witherspoon@northwestern.edu

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.

Official title: Study of Light Treatment and Laser Treatment for Melasma

Study design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Melasma Area and Severity Index (Time Frame: 20 weeks)

Secondary outcome: Safety (Time Frame: 20 weeks)

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.

Minimum eligible age: 18 Years. Maximum eligible age: 75 Years. Eligible gender(s): Both.

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.

Joslyn Witherspoon, MD, MPH, Phone: 312 695 0281, Email: j-witherspoon@northwestern.edu

Northwestern University Dermatology Department, Chicago, Illinois 60611, United States; Recruiting
Murad Alam, MD, Principal Investigator
Roopal Kundu, MD, Sub-Investigator
Lucile White, MD, Sub-Investigator
David M DiBardino, Sub-Investigator
Alfred Rademaker, PhD, Sub-Investigator
Simon Yoo, MD, Sub-Investigator
Mary Martini, MD, Sub-Investigator
Shadi Zari, MD, Sub-Investigator
Joslyn Witherspoon, MD, MPH, Sub-Investigator

Start date: April 2007
End date: December 2008
Last updated: April 18, 2008

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