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Evaluation of Tetrix Cream as a Protective Barrier Against Injurious Materials

This study has been completed.
Information provided by:
Coria Laboratories, Ltd. Identifier:
First received: March 20, 2008
Last updated: May 19, 2008
Last verified: May 2008
To determine if Tetrix Cream,, when applied to the skin, acts as a barrier to prevent injury to the skin

Condition Intervention
Device: Tetrix

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
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 ]

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


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Normal subjects who are sensitized to nickel, neomycin, or fragrance mix.

Exclusion Criteria:

  • Under 18 years of age.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00643630

United States, Kentucky
Dermatolgoy Specialists, LLC
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
Coria Laboratories, Ltd.
Principal Investigator: Joseph Fowler, MD Dermatology Specialists
  More Information

Responsible Party: D. Innes Cargill, PhD, Coria Laboratories, Ltd. Identifier: NCT00643630     History of Changes
Other Study ID Numbers: 806 805 09 002
Study First Received: March 20, 2008
Last Updated: May 19, 2008

Keywords provided by Coria Laboratories, Ltd.:
Tetrix crea
skin barrier
antigen reaction
The efficacy of Tetrix Cream to prevent an antigen reaction on the skin. processed this record on April 28, 2017