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Study of Acid Peel and Laser for the Treatment of Melasma

Primary Purpose

Melasma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Laser Treatment
Acid Peel
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melasma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Northwestern University Feinberg School of Medicine, Department of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Laser Treatment

Acid peel

Outcomes

Primary Outcome Measures

MASI

Secondary Outcome Measures

Safety

Full Information

First Posted
April 26, 2007
Last Updated
November 30, 2021
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT00467233
Brief Title
Study of Acid Peel and Laser for the Treatment of Melasma
Official Title
A Randomized, Rater-blinded, Split-face Comparison of the Efficacy of 30 % Salicylic Acid Peel vs. Q-switched Nd:Yag Laser for the Treatment of Melasma.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melasma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Laser Treatment
Arm Title
2
Arm Type
Experimental
Arm Description
Acid peel
Intervention Type
Procedure
Intervention Name(s)
Laser Treatment
Intervention Description
Laser treatment to half of the face at each study visit
Intervention Type
Procedure
Intervention Name(s)
Acid Peel
Intervention Description
Acid peel to half of the face at each study visit
Primary Outcome Measure Information:
Title
MASI
Time Frame
20 weeks
Secondary Outcome Measure Information:
Title
Safety
Time Frame
20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murad Alam, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University Feinberg School of Medicine, Department of Dermatology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

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Study of Acid Peel and Laser for the Treatment of Melasma

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