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Study of Acid Peel and Laser for the Treatment of Melasma
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Information provided by Northwestern University
Information obtained from ClinicalTrials.gov on June 16, 2008 Link to the current ClinicalTrials.gov record.
Condition(s) treated: Melasma
Intervention: Laser Treatment (Procedure); Acid Peel (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
Summary
The objective of this study is to evaluate laser treatment and acid peel for the treatment of
melasma.
Clinical Details
Official title: Study of Acid Peel and Laser for the Treatment of Melasma
Study design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: MASI (Time Frame: 20 weeks)
Secondary outcome: Safety (Time Frame: 20 weeks)
Detailed description: The purpose of this study is to evaluate the safety and efficacy of laser treatment and acid
peel for the treatment of melasma.
Eligibility
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.
Locations and Contact Information
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 Nicolle Martin, MD, Sub-Investigator Susan Boone, MD, Sub-Investigator Dennis West, PhD, Sub-Investigator Joslyn Witherspoon, MD, MPH, Sub-Investigator
Additional Information
Start date: May 2007
End date: December 2008
Last updated: April 18, 2008
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