Study of Acid Peel and Laser for the Treatment of Melasma - Tabular View

Tracking Information

First Received Date ^ICMJE

April 26, 2007

Last Updated Date

August 4, 2009

Start Date ^ICMJE

May 2007

Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

MASI [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Melasma Area and Severity Index (MASI) [ Time Frame: May 2008 ]
Score on a visual analog scale generated by a dermatologist rater [ Time Frame: May 2008 ]

Change History

Complete list of historical versions of study NCT00467233 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Safety [ Time Frame: 20 weeks ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Score on a visual analog scale generated by patient who received treatment [ Time Frame: May 2008 ]
Any adverse events experienced post-treatment [ Time Frame: May 2008 ]
Melasma quality of life questionnaire (MELAQOL) [ Time Frame: May 2008 ]

Descriptive Information

Brief Title ^ICMJE

Study of Acid Peel and Laser for the Treatment of Melasma

Official Title ^ICMJE

Study of Acid Peel and Laser for the Treatment of Melasma

Brief Summary

The objective of this study is to evaluate laser treatment and acid peel for the treatment of melasma.

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Melasma

Intervention ^ICMJE

Procedure: Laser Treatment
Procedure: Acid Peel

Study Arms / Comparison Groups

Experimental: Laser Treatment
Experimental: Acid peel

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2010

Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00467233

Responsible Party

Northwestern University, Murad Alam, MD

Study ID Numbers ^ICMJE

MA-123456-DD

Study Sponsor ^ICMJE

Northwestern University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Murad Alam, MD

Northwestern University

Information Provided By

Northwestern University

Verification Date

August 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP