Healthy Volunteers Clinical Trial
Official title:
Optimization of Tuberculosis Intradermal Skin Test: TB Dermatest WP 3.1
The only test available for in vivo diagnosis of tuberculosis is the intradermal injection
of tuberculin according to the Mantoux method (also named tuberculosis skin test or PPD skin
test).
The tuberculin skin test is based on a delayed-type hypersensitivity skin reaction However,
this test needs to be performed by trained personnel, presents problem of reproducibility,
and its interpretation is not well standardized (measure in millimeters of skin induration
48 to 72 hours after the PPD skin test).
The new generation BD micro needle used in this study should solve the technical
difficulties; intradermal administration of tuberculin could then be made by any personnel.
A non-invasive and objective instrumental method of reading the test will be also tested .
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Diagnostic
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