CompletedPhase 1ACTRN12606000424505
A Phase 1 Single-Center, Randomized, Placebo-Controlled, Double-Blind Pilot Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of a Candidate Topical Antimicrobial (NEO101) in the Reduction of Propionibacterium acnes among Healthy Young Adult Men
Sponsor
Neosil, Inc.
Enrollment
30 participants
Start Date
Oct 16, 2006
Study Type
Interventional
Conditions
Summary
This study will evaluate the safety of a new anti-infective gel, and will also measure how well it is tolerated when applied two times a day to the forehead for 28 days.
Eligibility
Sex: MalesMin Age: 18 YearssMax Age: 45 Yearss
Inclusion Criteria1
- Sign an informed consent;- are in general good health;-do not have active acne lesions on the forehead;- are colonized with P. acnes, as demonstrated by a screening culture with a P. acnes count of >10,000/cm2 on facial skin (forehead);- have not used any form of topical or systemic antibiotics within 28 days prior to enrollment;- compliant with adequate birth control (defined).
Exclusion Criteria1
- Have concomitant dermatologic or medical condition(s) which may interfere wtih the investigator's ability to evaluate the subject's response to the study drug;- have atopic dermatitis, active allergic rhinitis, or nasal polyps, seborrheic dermatitis or psoriasis, or any facial piercing;- have a history of hypersensitivity or allergic to parabens, sodium sulfite or any other ingredient in the vehicle formulation.
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Interventions
Eligible subjects will be randomized to receive active treatment with 0.95% NEO101 gel which will be applied to the forehead twice daily for a total of 28 days. A 2-week follow-up period will follow
Eligible subjects will be randomized to receive active treatment with 0.95% NEO101 gel which will be applied to the forehead twice daily for a total of 28 days. A 2-week follow-up period will follow the treatment period.
Locations(1)
View Full Details on ANZCTR
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ACTRN12606000424505