Clinical Trial: Study to Evaluate the Efficacy and Safety of P-3058 Nail Solution in the Treatment of Onychomycosis

Study Status: Not yet recruiting
Recruit Status: Not yet 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 aim of this phase III study is to establish the efficacy and safety of P-3058 (terbinafine 10% nail solution) topically administered once weekly in patients with onychomycosis in comparison to the Vehicle in a double-blind fashion. The overall treatment period will be of 48 weeks.

Detailed Summary: The study will consist of a screening phase, a treatment phase of 48 weeks and a 12-week follow-up. Patients affected by mild to-moderate distal lateral subungual onychomycosis (DLSO) on a target great toenail will be included in the study. Clinical as well as mycology assessments will be performed throughout the whole study. Safety will be monitored by recording any adverse event and evaluating local tolerability.
Sponsor: Polichem S.A.

Current Primary Outcome: Rate of complete cure at Week 60 [ Time Frame: Baseline - Week 60 ]

Defined as composite of negative KOH microscopy and negative culture for dermatophytes and no residual clinical involvement (nail totally clear) of the target nail.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Responder rate at Week 60 [ Time Frame: Baseline - Week 60 ]
    Defined as negative Potassium Hydroxide (KOH) microscopy and negative culture for dermatophytes and ≤ 10% residual involvement of the target toenail)
  • Mycological cure rate at Week 60 [ Time Frame: Baseline - Week 60 ]
    Defined as negative Potassium Hydroxide (KOH) microscopy and negative culture for dermatophytes of the target nail.


Original Secondary Outcome: Same as current

Information By: Polichem S.A.

Dates:
Date Received: March 21, 2017
Date Started: May 2017
Date Completion: December 2019
Last Updated: March 23, 2017
Last Verified: March 2017