Evaluation of Tetrix Cream as a Protective Barrier Against Injurious Materials

May 19, 2008 updated by: Coria Laboratories, Ltd.

A Study to Determine the Skin Barrier Effect of Tetrix Cream

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Under 18 years of age.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevention of delayed bype hypersensitivity reaction following application of antigen
Time Frame: up to 96 hours after antigen application
up to 96 hours after antigen application

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Coria Laboratories, Ltd.

Investigators

  • Principal Investigator: Joseph Fowler, MD, Dermatology Specialists

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

March 20, 2008

First Submitted That Met QC Criteria

March 25, 2008

First Posted (Estimate)

March 26, 2008

Study Record Updates

Last Update Posted (Estimate)

May 22, 2008

Last Update Submitted That Met QC Criteria

May 19, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 806 805 09 002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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