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

Not Applicable

Completed

• Conditions: Colonization, Asymptomatic
• Interventions: Other: Saline applied via swab; Other: Povidone-iodine based gel

• Registration Number: NCT05617729
• Lead Sponsor: Center for Innovation and Research Organization

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-07
• Primary Completion: 2022-03-18
• Study Completion: 2022-03-31
• Status Verified: 2022-11
• Study First Submitted: 2022-11-08
• Study First Submitted QC: 2022-11-08
• Last Update Submitted: 2022-11-08
• Study First Posted: 2022-11-15
• Last Update Posted: 2022-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline	Saline applied via swab	this treatment consists of sterile saline that is applied to the nares using a swab
Povidone-iodine based gel	Povidone-iodine based gel	this treatment consists of a Povidone-Iodine based gel that is applied to the nares using a swab

Primary Outcome Measures

Name	Time	Method
Colony Forming Units	up to 24 hours following application

Trial Locations

Locations (1)

Center for Innovation and Research Organization; 🇺🇸 Philadelphia, Pennsylvania, United States