A Clinical Simulation Study of a Test Material on the Anterior Nares

Center for Innovation and Research Organization

Status: Completed

Conditions: Colonization, Asymptomatic

Treatments: Other: Povidone-iodine based gel; Other: Saline applied via swab

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT05617729

Povinez001

Details and patient eligibility

About

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).

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Subject is male or female between 18 to 55 years of age;
2. Subject has normal nasal passage;
3. Subject has not history of chronic nasal passage disease (chronic rhinitis, chronic sinusitis).
4. Subject is willing to have materials applied and follow the protocol;
5. Subject agrees to avoid exposure of the test sites to any chemical product and to refrain from touching the area of application.
6. 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;
7. Subject agrees not to introduce any new cosmetic or toiletry products during the study;
8. Subject is dependable and able to follow directions as outlined in the protocol and anticipates being available for all study visits;
9. Subject is willing to participate in all study evaluations;
10. Subject is in generally good health;
11. Subject understands and is willing to sign an Informed Consent Form

Exclusion criteria

1. Female subject is pregnant, nursing, planning a pregnancy, or not using adequate birth control;
2. Subject has a chronic nasal disease (e.g sinusitis, rhinitis);
3. Subject has a bleeding disorder, immunologically compromised, recent illness/vaccination or currently febrile;
4. Subject reports a history of allergies to antiseptics;
5. Subject is currently taking certain medications which, in the opinion of the Principal Investigator, may interfere with the study;
6. Subject has known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups, including a placebo group

Saline

Placebo Comparator group

Description:

this treatment consists of sterile saline that is applied to the nares using a swab

Treatment:

Other: Saline applied via swab

Povidone-iodine based gel

Active Comparator group

Description:

this treatment consists of a Povidone-Iodine based gel that is applied to the nares using a swab

Treatment:

Other: Povidone-iodine based gel