A Clinical Simulation Study of a Test Material on the Anterior Nares (NCT05617729) | Clinical Trial Compass
CompletedNot Applicable
A Clinical Simulation Study of a Test Material on the Anterior Nares
United States50 participantsStarted 2022-03-07
Plain-language summary
The objective of this study is simulate the clinical use of a test material within a 24h window. Efficacy will be simulated as the capacity of the material to reduce or clear the anterior nares bacterial population from opportunistic pathogens (e.g. Staphylococcus Aureus, Escherichia Coli, etc).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subject is male or female between 18 to 55 years of age;
✓. Subject has normal nasal passage;
✓. Subject has not history of chronic nasal passage disease (chronic rhinitis, chronic sinusitis).
✓. Subject is willing to have materials applied and follow the protocol;
✓. Subject agrees to avoid exposure of the test sites to any chemical product and to refrain from touching the area of application.
✓. Subject agrees to refrain from getting the application site wet and scrubbing or washing the test area with soap or applying powders, lotions or personal care products to the area during the course of the study;
✓. Subject agrees not to introduce any new cosmetic or toiletry products during the study;
✓. Subject is dependable and able to follow directions as outlined in the protocol and anticipates being available for all study visits;
Exclusion criteria
✕. Female subject is pregnant, nursing, planning a pregnancy, or not using adequate birth control;
✕. Subject has a chronic nasal disease (e.g sinusitis, rhinitis);
✕. Subject has a bleeding disorder, immunologically compromised, recent illness/vaccination or currently febrile;
✕
What they're measuring
1
Colony Forming Units
Timeframe: up to 24 hours following application
Trial details
NCT IDNCT05617729
SponsorCenter for Innovation and Research Organization