- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07698938
The Safety and Microbial Changes in the Use of Intranasal Neosporin®
July 10, 2026 updated by: Dr. Adrian Camacho-Ortiz, Hospital Universitario Dr. Jose E. Gonzalez
The Safety and Microbial Changes in the Use of Intranasal Neosporin®: A Prospective Study
Neosporin is an over-the-counter, FDA-approved triple-antibiotic ointment.
It is widely used to treat and prevent skin infections following minor burns and injuries.
Although the Neosporin® prospect indicates its use is strictly topical, it is often used intranasally by ear, nose, and throat specialists, plastic surgeons, and intensivists to prevent and treat various conditions.
Nonetheless, no literature has documented the safety of intranasal Neosporin®.
We designed a prospective study to assess the safety of this intervention in healthy participants and to investigate microbial changes before and after the intervention.
Healthy participants will apply Neosporin® intranasally for 15 days and record daily adverse events and their severity.
Nasal cultures will be drawn before and after the intervention and compared.
Study Overview
Status
Completed
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nuevo León
-
Monterrey, Nuevo León, Mexico, 64460
- Hospital Universitario "Dr. José Eleuterio González"
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Age between 18 and 65 years
- Signed informed consent
- Healthy volunteers
Exclusion Criteria:
- Chronic or recurrent nasal conditions
- Current use of other intranasal medications
- History of severe allergic reactions to antibiotics
- History of allergy to the components of Neosporin®
- Participation in another research protocol
- Being a staff member or an immediate family member of a staff member
- Pregnant women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Polymyxin B Sulfate 500,000 IU, Bacitracin zinc 40,000 IU, Neomycin Sulfate 0.35g neomycin base
0.5 gr of Polymyxin B Sulfate 500,000 IU, Bacitracin zinc 40,000 IU, Neomycin Sulfate 0.35g neomycin base will be applied intranasally in healthy participants for 15 days
|
We want to test the safety of the intranasal application of Neosporin® (Polymyxin B Sulfate 500,000 IU, Bacitracin zinc 40,000 IU, Neomycin Sulfate 0.35g neomycin base) since it has not been tested.
Sing and symptom diaries and nasal swabs for culture will be collected
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Adverse events of intranasal Neosporin® in healthy participants.
Time Frame: 16 days
|
16 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Adrian Camacho Ortiz, MD, PhD, Hospital Universitario Dr. Jose Eleuterio González
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 13, 2025
Primary Completion (Actual)
March 22, 2025
Study Completion (Actual)
March 23, 2025
Study Registration Dates
First Submitted
July 7, 2026
First Submitted That Met QC Criteria
July 7, 2026
First Posted (Actual)
July 13, 2026
Study Record Updates
Last Update Posted (Actual)
July 14, 2026
Last Update Submitted That Met QC Criteria
July 10, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IF24-00009
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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