None listed
Conditions
Brief 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.
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 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
Male
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
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 criteria
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.
Outcome results
None listed