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 Me
- Conditions
- Propionibacterium acnes amongst healthy volunteersSkin - Dermatological conditions
- Registration Number
- ACTRN12606000424505
- Lead Sponsor
- eosil, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 30
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).
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the safety and tolerability of twice-daily (bid) topical application of NEO101 in healthy adult male subjects. [Assessed at baseline and then at each study visit (every weekday during the 28-day treatment period), and at the end of the two-week post-treatment follow-up period.]
- Secondary Outcome Measures
Name Time Method To make a preliminary evaluation of the efficacy of twice-daily (bid) topical application of NEO101 as an anti-acne preparation, by quantitative microbiologic determinations of Propionibacterium acnes levels before, during and after treatment in normal healthy adult male subjects.[This outcome will be measured at baseline and on a weekly basis during and immediately following the treatment period (through Study Day 29).]