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Completed

NCT Number: NCT05617729

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Innovation and Research Organization

Philadelphia, Pennsylvania, 19107, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Saline applied via swab

Other

sterile saline applied via swab

Povidone-iodine based gel

Other

gel applied via swab

Primary outcomes

  1. Colony Forming Units

    Time frame: up to 24 hours following application

Sponsors and collaborators

Lead sponsor

Center for Innovation and Research Organization

Network

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 15, 2022
Registry last updated
Nov 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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