NCT03094468

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

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

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Polichem S.A. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Onychomycosis of Toenail

Interventions

Type	Name	Description
DRUG	P-3058 (terbinafine hydrochloride 10%)	Patients will apply the P-3058 nail solution once weekly in a double blind fashion. The overall treatment phase is of 48 weeks.
DRUG	Vehicle of P-3058	Patients will apply the Vehicle of P-3058 once weekly in a double blind fashion. The overall treatment phase is of 48 weeks.

Timeline

• Start date: 2017-05-01
• Primary completion: 2019-10-01
• Completion: 2019-12-01
• First posted: 2017-03-29
• Last updated: 2018-01-10

Locations

26 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study