NCT00166192

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2008

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
2.3 years until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

November 14, 2013

Status Verified

November 1, 2013

Enrollment Period

2 years

First QC Date

September 13, 2005

Last Update Submit

November 12, 2013

Conditions

Melasma

Keywords

MelasmaJessner's solutionTrichloroacetic acid (TCA)

Outcome Measures

Primary Outcomes (1)

  • Clinical efficacy by clinician's evaluation

    Hyperpigmenation Global Score

    3 months

Secondary Outcomes (1)

  • Efficacy by subject's evaluation

    3 months

Study Arms (1)

Chemical Peel

ACTIVE COMPARATOR

Split face treatment paradigm

Procedure: Jessner's solution chemical peelProcedure: Trichloroacetic acid chemical peel

Interventions

Jessner's solution chemical peelPROCEDURE
Chemical Peel
Trichloroacetic acid chemical peelPROCEDURE
Chemical Peel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults \> 18 years old
  • Clinical diagnosis of melasma
  • Mental capacity to give informed consent

You may not qualify if:

  • Pregnancy
  • H/o allergy to Jessner's solution, tricholoracetetic acid, tretinoin, or hydroquinone
  • Active dermatitis
  • Presence of cutaneous infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University Dermatology Clinic

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Melanosis

Condition Hierarchy (Ancestors)

HyperpigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Carl Washington, MD

    Emory University Department of Dermatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 14, 2005

Study Start

January 1, 2008

Primary Completion

January 1, 2010

Study Completion

November 1, 2013

Last Updated

November 14, 2013

Record last verified: 2013-11

Locations

US(1)