Evaluation of Tetrix Cream as a Protective Barrier Against Injurious Materials
This study has been completed.
Sponsor:
Coria Laboratories, Ltd.
Information provided by:
Coria Laboratories, Ltd.
ClinicalTrials.gov Identifier:
NCT00643630
First received: March 20, 2008
Last updated: May 19, 2008
Last verified: May 2008
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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 May 23, 2013