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

Primary Purpose

Colonization, Asymptomatic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Saline applied via swab
Povidone-iodine based gel
Sponsored by
Center for Innovation and Research Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colonization, Asymptomatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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; Subject is willing to participate in all study evaluations; Subject is in generally good health; Subject understands and is willing to sign an Informed Consent Form 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; Subject reports a history of allergies to antiseptics; Subject is currently taking certain medications which, in the opinion of the Principal Investigator, may interfere with the study; Subject has known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs

Sites / Locations

  • Center for Innovation and Research Organization

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Saline

Povidone-iodine based gel

Arm Description

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

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

Outcomes

Primary Outcome Measures

Colony Forming Units

Secondary Outcome Measures

Full Information

First Posted
November 8, 2022
Last Updated
November 8, 2022
Sponsor
Center for Innovation and Research Organization
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1. Study Identification

Unique Protocol Identification Number
NCT05617729
Brief Title
A Clinical Simulation Study of a Test Material on the Anterior Nares
Official Title
A Clinical Simulation Study of a Test Material on the Anterior Nares
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
March 7, 2022 (Actual)
Primary Completion Date
March 18, 2022 (Actual)
Study Completion Date
March 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Center for Innovation and Research Organization

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonization, Asymptomatic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
this treatment consists of sterile saline that is applied to the nares using a swab
Arm Title
Povidone-iodine based gel
Arm Type
Active Comparator
Arm Description
this treatment consists of a Povidone-Iodine based gel that is applied to the nares using a swab
Intervention Type
Other
Intervention Name(s)
Saline applied via swab
Intervention Description
sterile saline applied via swab
Intervention Type
Other
Intervention Name(s)
Povidone-iodine based gel
Intervention Description
gel applied via swab
Primary Outcome Measure Information:
Title
Colony Forming Units
Time Frame
up to 24 hours following application

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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; Subject is willing to participate in all study evaluations; Subject is in generally good health; Subject understands and is willing to sign an Informed Consent Form 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; Subject reports a history of allergies to antiseptics; Subject is currently taking certain medications which, in the opinion of the Principal Investigator, may interfere with the study; Subject has known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs
Facility Information:
Facility Name
Center for Innovation and Research Organization
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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