None listed
Conditions
Brief summary
This study will evaluate the safety of a new antimicrobial (NEO101) applied to the inside of the nose twice-daily for 7 days. The reduction or eradication by the antimicrobial of nasal Staphylcoccus aureus will also be evaluated.
Interventions
Eligible subjects will receive either 0.95% NEO101, which will be administered twice daily by topical application to the inside of each nostril, for a 7-day treatment course. A 14-day safety and efficacy assessment period will follow the treatment period.
Sponsors
Neosil, Inc.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Subjects in general good health, have nasal cultures positive for S. aureus, are compliant with (defined) birth control.
Exclusion criteria
Subjects have concomitant dermatologic or medical condition(s) which may interfere with the investigator's ability to evaluate the subject's response to the study drug, have clinical evidence of active cutaneous infection, have had skin or soft tissue infection with S. aureus within 30 days prior to randomization, have documented disruption of the nasal or facial bones, have atopic dermatitis/eczema, allergic rhinitis, nasal polyps, or nasal piercings, have a history of hypersensitivity or allergic reaction to parabens, sodium sulfite or any other ingredient in the vehicle formulation.
Outcome results
None listed