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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-07

Study Completion Date

2022-03-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Colonization, Asymptomatic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Saline

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

Group Type PLACEBO_COMPARATOR

Saline applied via swab

Intervention Type OTHER

sterile saline applied via swab

Povidone-iodine based gel

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

Group Type ACTIVE_COMPARATOR

Povidone-iodine based gel

Intervention Type OTHER

gel applied via swab

Interventions

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Saline applied via swab

sterile saline applied via swab

Intervention Type OTHER

Povidone-iodine based gel

gel applied via swab

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes