Evaluation of Tetrix Cream as a Protective Barrier Against Injurious Materials

This study has been completed.
Sponsor:
Information provided by:
Coria Laboratories, Ltd.
ClinicalTrials.gov Identifier:
NCT00643630
First received: March 20, 2008
Last updated: May 19, 2008
Last verified: May 2008
  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: 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 ] [ 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
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Under 18 years of age.
  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: D. Innes Cargill, PhD, Coria Laboratories, Ltd.
ClinicalTrials.gov Identifier: NCT00643630     History of Changes
Other Study ID Numbers: 806 805 09 002
Study First Received: March 20, 2008
Last Updated: May 19, 2008
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.

ClinicalTrials.gov processed this record on April 15, 2014