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

Propionibacterium acnes amongst healthy volunteers

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

Plain Language Summary

Simplified for easier understanding

This early-phase study tests a new topical antimicrobial product (NEO101) to see if it safely reduces the bacteria that cause acne on facial skin. Healthy men ages 18 to 45 without active acne on the forehead can join. Participants apply the product to their forehead skin over several weeks.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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)

Australia

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ACTRN12606000424505