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NCT00633009 · ClinicalTrials.gov registry record · Phase 2
Safety, False-Positive Reactions and Sensitizing Properties of Leishmania Tropica Skin Test Antigen
A Phase 2 study, sponsored by Nielsen BioSciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
NCT00633009 is a Phase 2 study that has completed, run by Nielsen BioSciences. The registered enrollment target is 50 participants.
The verdict
NCT00633009, a Phase 2 study, has completed, sponsored by Nielsen BioSciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
Study Summary
The efficacy of LtSTA as a skin test antigen depends upon the sensitivity and specificity of the product. This study has been designed to measure the skin test responses to 15, 30, or 50µg doses of LtSTA. The measurements of non-specific reactivity due to components of the antigen solution and the product's ability to sensitize lymphocytes of Leishmania naïve persons when administered intradermally. The presence or absence of a local inflammatory response to the first skin test with each of three doses of LtSTA will provide insight on the specificity of the antigen in a naïve population. The local inflammatory response to LtSTA following the first and second repeat skin tests will indicate if the antigen is sensitizing after intradermal administration.
Interventions
- BIOLOGICAL Leishmania tropica Skin Test Antigen (LtSTA)
- BIOLOGICAL Leishmania tropica Skin Test Antigen Placebo (Placebo)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2008-08 |
| Est. Completion | 2010-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00633009
The ClinicalTrials.gov registry entry for NCT00633009 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nielsen BioSciences, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Leishmania tropica Skin Test Antigen (LtSTA) is the first listed.
NCT00633009 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00633009 about?
NCT00633009 is a clinical study titled "Safety, False-Positive Reactions and Sensitizing Properties of Leishmania Tropica Skin Test Antigen". The efficacy of LtSTA as a skin test antigen depends upon the sensitivity and specificity of the product. This study has been designed to measure the skin test responses to 15, 30, or 50µg doses of LtSTA. The measurements of non-specific reactivity due to components of the antigen solution and the p...
What is the current status of trial NCT00633009?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2008-08. Estimated completion is 2010-01.
What interventions are being tested in trial NCT00633009?
The interventions under investigation include: Leishmania tropica Skin Test Antigen (LtSTA) (BIOLOGICAL), Leishmania tropica Skin Test Antigen Placebo (Placebo) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00633009?
This trial is sponsored by Nielsen BioSciences, which has 5 total clinical trials registered on ClinicalTrials.gov.
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