CompletedPhase 2ACTRN12607000267459

A Phase 1/2, Single-Center, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of a Topical Antimicrobial (NEO101) in the Reduction or Eradication of Staphylococcus aureus Nasal Carriage among Adults


Sponsor

Neosil, Inc.

Enrollment

36 participants

Start Date

Jun 8, 2007

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Inclusion Criteria1

  • Subjects in general good health, have nasal cultures positive for S. aureus, are compliant with (defined) birth control.

Exclusion Criteria1

  • 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.

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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 effi

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.


Locations(1)

Australia

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ACTRN12607000267459