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
| Tracking Information | |||||
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| First Received Date ICMJE | March 20, 2008 | ||||
| Last Updated Date | May 19, 2008 | ||||
| Start Date ICMJE | October 2007 | ||||
| Primary Completion Date | October 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Prevention of delayed bype hypersensitivity reaction following application of antigen [ Time Frame: up to 96 hours after antigen application ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00643630 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Evaluation of Tetrix Cream as a Protective Barrier Against Injurious Materials | ||||
| Official Title ICMJE | A Study to Determine the Skin Barrier Effect of Tetrix Cream | ||||
| Brief Summary | To determine if Tetrix Cream,, when applied to the skin, acts as a barrier to prevent injury to the skin |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Single Blind (Investigator) Primary Purpose: Prevention |
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| Condition ICMJE | Healthy | ||||
| Intervention ICMJE | Device: Tetrix
Twice daily topical application |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 36 | ||||
| Completion Date | November 2007 | ||||
| Primary Completion Date | October 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 50 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00643630 | ||||
| Other Study ID Numbers ICMJE | 806 805 09 002 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | D. Innes Cargill, PhD, Coria Laboratories, Ltd. | ||||
| Study Sponsor ICMJE | Coria Laboratories, Ltd. | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Coria Laboratories, Ltd. | ||||
| Verification Date | May 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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