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Evaluation of Tetrix Cream as a Protective Barrier Against Injurious Materials

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00643630
First Posted: March 26, 2008
Last Update Posted: May 22, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Coria Laboratories, Ltd.
  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 (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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: D. Innes Cargill, PhD, Coria Laboratories, Ltd.
ClinicalTrials.gov Identifier: NCT00643630     History of Changes
Other Study ID Numbers: 806 805 09 002
First Submitted: March 20, 2008
First Posted: March 26, 2008
Last Update Posted: May 22, 2008
Last Verified: May 2008

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.