Evaluation of Tetrix Cream as a Protective Barrier Against Injurious Materials

NCT ID: NCT00643630

Last Updated: 2008-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2007-11-30

Brief Summary

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

Detailed Description

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Conditions

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Healthy

Keywords

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Tetrix crea skin barrier antigen reaction prevention The efficacy of Tetrix Cream to prevent an antigen reaction on the skin.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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1

Twice daily topical application

Group Type EXPERIMENTAL

Tetrix

Intervention Type DEVICE

Twice daily topical application

2

Twice daily topical application

Group Type PLACEBO_COMPARATOR

Tetrix

Intervention Type DEVICE

Twice daily topical application

Interventions

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Tetrix

Twice daily topical application

Intervention Type DEVICE

Tetrix

Twice daily topical application

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Under 18 years of age.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Coria Laboratories, Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Coria Laboratories, Ltd.

Principal Investigators

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Joseph Fowler, MD

Role: PRINCIPAL_INVESTIGATOR

Dermatology Specialists

Locations

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Dermatolgoy Specialists, LLC

Louisville, Kentucky, United States

Site Status

Countries

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United States

Other Identifiers

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806 805 09 002

Identifier Type: -

Identifier Source: org_study_id