Back to resultsTreatment of Melasma With Jessner's Solution vs. Trichloroacetic Acid
Primary Purpose
Melasma
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Jessner's solution chemical peel
Trichloroacetic acid chemical peel
Sponsored by
About this trial
This is an interventional treatment trial for Melasma focused on measuring Melasma, Jessner's solution, Trichloroacetic acid (TCA)
Eligibility Criteria
Inclusion Criteria: Adults > 18 years old Clinical diagnosis of melasma Mental capacity to give informed consent Exclusion Criteria: Pregnancy H/o allergy to Jessner's solution, tricholoracetetic acid, tretinoin, or hydroquinone Active dermatitis Presence of cutaneous infection
Sites / Locations
- Emory University Dermatology Clinic
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
Chemical Peel
Arm Description
Split face treatment paradigm
Outcomes
Primary Outcome Measures
Clinical efficacy by clinician's evaluation
Hyperpigmenation Global Score
Secondary Outcome Measures
Efficacy by subject's evaluation
Hyperpigmentation Global Score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00166192
Brief Title
Treatment of Melasma With Jessner's Solution vs. Trichloroacetic Acid
Official Title
Treatment of Melasma With Jessner's Solution vs. Trichloroacetic Acid: A Comparison of Clinical Efficacy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Melasma is an acquired discoloration of the skin characterized by brown patches. Chemical peels using agents such as Jessner's solution and trichloroacetic acid (TCA) are commonly used to treat melasma. A chemical peel involves applying the peeling agent to the skin for a short period. The skin will peel similar to a sunburn, and moisturizers are applied to the skin. Although both agents are well-accepted, there have been no good comparisons of the two agents. The purpose of this study is determine if there is a difference in the effectiveness of these two agents.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melasma
Keywords
Melasma, Jessner's solution, Trichloroacetic acid (TCA)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chemical Peel
Arm Type
Active Comparator
Arm Description
Split face treatment paradigm
Intervention Type
Procedure
Intervention Name(s)
Jessner's solution chemical peel
Intervention Type
Procedure
Intervention Name(s)
Trichloroacetic acid chemical peel
Primary Outcome Measure Information:
Title
Clinical efficacy by clinician's evaluation
Description
Hyperpigmenation Global Score
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Efficacy by subject's evaluation
Description
Hyperpigmentation Global Score
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults > 18 years old
Clinical diagnosis of melasma
Mental capacity to give informed consent
Exclusion Criteria:
Pregnancy
H/o allergy to Jessner's solution, tricholoracetetic acid, tretinoin, or hydroquinone
Active dermatitis
Presence of cutaneous infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carl Washington, MD
Organizational Affiliation
Emory University Department of Dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University Dermatology Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Treatment of Melasma With Jessner's Solution vs. Trichloroacetic Acid
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