Treatment of Melasma With Jessner's Solution vs. Trichlor... | NCT00166192

Studies
Treatment of Melasma With Jessner's Solution vs. Trichloroacetic Acid

NCT00166192

Sponsor

Emory University

Status

Completed

Last Update Posted

Nov 14, 2013Estimated

Enrollment

19Actual

Phase

Phase 4

Conditions

Melasma

Interventions

Jessner's solution chemical peel
Trichloroacetic acid chemical peel

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Jan 2010Actual

Completion Date

Nov 2013Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 14, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 12, 2013

Last Update Posted Date

Nov 14, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Chemical Peel	Active Comparator	Split face treatment paradigm	Procedure: Jessner's solution chemical peel Procedure: Trichloroacetic acid chemical peel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Jessner's solution chemical peel	Procedure		Chemical Peel
Trichloroacetic acid chemical peel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical efficacy by clinician's evaluation	Hyperpigmenation Global Score	3 months

Secondary Outcomes

Measure	Description	Time Frame
Efficacy by subject's evaluation	Hyperpigmentation Global Score	3 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carl Washington, MD	Emory University Department of Dermatology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Emory University Dermatology Clinic		Atlanta	Georgia	30322	United States

Condition Browse Module

MeSH Terms

ID	Term
D008548	Melanosis

Ancestor Terms

ID	Term
D017495	Hyperpigmentation
D010859	Pigmentation Disorders
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided