Clinical Trial: Study to Evaluate the Efficacy and Safety of P-3058 10% Nail Solution in the Treatment of Toenail Onychomycosis
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Multicenter, Randomized, Double-blind, Parallel, Vehicle-controlled Study to Evaluate the Efficacy and Safety of P-3058 10% Nail Solution in the Treatment of Onychomycosis
Brief Summary: The purpose of this study is to determine whether P-3058 nail solution is a safe and effective treatment for onychomycosis.
Detailed Summary:
Sponsor: Polichem S.A.
Current Primary Outcome: Complete cure of target great toenail defined as negative KOH microscopy, negative culture for dermatophytes and target nail totally clear. [ Time Frame: Week 60 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Responder rate of the target toenail, defined as negative KOH microscopy, negative culture for dermatophytes and ≤10% residual involvement of the target toenail. [ Time Frame: Week 60 ]
- Negative culture rate for dermatophytes of the target nail. [ Time Frame: Week 60 ]
- Mycological cure defined as negative KOH microscopy and negative culture for dermatophytes of the target nail. [ Time Frame: Week 60 ]
- Overall safety by recording any AE during the entire study duration and the local tolerability by means of severity scores for skin irritation. [ Time Frame: Week 60 ]
Original Secondary Outcome: Same as current
Information By: Polichem S.A.
Dates:
Date Received: September 8, 2015
Date Started: August 20, 2015
Date Completion: June 2018
Last Updated: May 17, 2017
Last Verified: May 2017
