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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zakiya Rice, Emory University
ClinicalTrials.gov Identifier:
NCT00166192
First received: September 13, 2005
Last updated: November 12, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Melasma
Procedure: Jessner's solution chemical peel
Procedure: Trichloroacetic acid chemical peel
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Melasma With Jessner's Solution vs. Trichloroacetic Acid: A Comparison of Clinical Efficacy

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Clinical efficacy by clinician's evaluation [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Hyperpigmenation Global Score


Secondary Outcome Measures:
  • Efficacy by subject's evaluation [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Hyperpigmentation Global Score


Enrollment: 19
Study Start Date: January 2008
Study Completion Date: November 2013
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Chemical Peel
Split face treatment paradigm
Procedure: Jessner's solution chemical peel Procedure: Trichloroacetic acid chemical peel

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00166192

Locations
United States, Georgia
Emory University Dermatology Clinic
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Carl Washington, MD Emory University Department of Dermatology
  More Information

No publications provided

Responsible Party: Zakiya Rice, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00166192     History of Changes
Other Study ID Numbers: IRB00024850
Study First Received: September 13, 2005
Last Updated: November 12, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Emory University:
Melasma
Jessner's solution
Trichloroacetic acid (TCA)

Additional relevant MeSH terms:
Ethanol
Pharmaceutical Solutions
Salicylates
Analgesics
Analgesics, Non-Narcotic
Anti-Infective Agents
Anti-Infective Agents, Local
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Central Nervous System Depressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014