Evaluation of Tetrix Cream as a Protective Barrier Against Injurious Materials

This study has been completed.

First Received: March 20, 2008 Last Updated: May 19, 2008 History of Changes

Sponsored by:	Coria Laboratories, Ltd.
Information provided by:	Coria Laboratories, Ltd.
ClinicalTrials.gov Identifier:	NCT00643630

Purpose

To determine if Tetrix Cream,, when applied to the skin, acts as a barrier to prevent injury to the skin

Condition	Intervention
Healthy	Device: Tetrix

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Investigator), Single Group Assignment
Official Title:	A Study to Determine the Skin Barrier Effect of Tetrix Cream

Further study details as provided by Coria Laboratories, Ltd.:

Primary Outcome Measures:

Prevention of delayed bype hypersensitivity reaction following application of antigen [ Time Frame: up to 96 hours after antigen application ] [ Designated as safety issue: Yes ]

Enrollment:	36
Study Start Date:	October 2007
Study Completion Date:	November 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Twice daily topical application	Device: Tetrix Twice daily topical application
2: Placebo Comparator Twice daily topical application	Device: Tetrix Twice daily topical application

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00643630

Locations

United States, Kentucky
Dermatolgoy Specialists, LLC
Louisville, Kentucky, United States, 40202

Sponsors and Collaborators

Coria Laboratories, Ltd.

Investigators

Principal Investigator:

Joseph Fowler, MD

Dermatology Specialists

More Information

No publications provided

Responsible Party:	Coria Laboratories, Ltd. ( D. Innes Cargill, PhD )
Study ID Numbers:	806 805 09 002
Study First Received:	March 20, 2008
Last Updated:	May 19, 2008
ClinicalTrials.gov Identifier:	NCT00643630 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Coria Laboratories, Ltd.:

Tetrix crea
skin barrier
antigen reaction
prevention
The efficacy of Tetrix Cream to prevent an antigen reaction on the skin.

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on May 07, 2009