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
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: 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 July 26, 2014