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

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).

Study Overview

• Status: Completed
• Conditions: Colonization, Asymptomatic
• Intervention / Treatment: Other: Saline applied via swab; Other: Povidone-iodine based gel

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Center for Innovation and Research Organization

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Saline; this treatment consists of sterile saline that is applied to the nares using a swab	Other: Saline applied via swab; sterile saline applied via swab
Active Comparator: Povidone-iodine based gel; this treatment consists of a Povidone-Iodine based gel that is applied to the nares using a swab	Other: Povidone-iodine based gel; gel applied via swab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Colony Forming Units	up to 24 hours following application

Collaborators and Investigators

• Sponsor: Center for Innovation and Research Organization

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2022
• Primary Completion (Actual): March 18, 2022
• Study Completion (Actual): March 31, 2022

Study Registration Dates

• First Submitted: November 8, 2022
• First Submitted That Met QC Criteria: November 8, 2022
• First Posted (Actual): November 15, 2022

Study Record Updates

• Last Update Posted (Actual): November 15, 2022
• Last Update Submitted That Met QC Criteria: November 8, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Disease Attributes; Asymptomatic Diseases; Asymptomatic Infections; Anti-Infective Agents, Local; Anti-Infective Agents; Plasma Substitutes; Blood Substitutes; Povidone-Iodine; Povidone
• Other Study ID Numbers: Povinez001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No