Trials Sponsors Conditions Drugs Pricing

Conditions

Onychomycosis of Toenail

Keywords

terbinafine nail solutionnail fungal infectiontopical antifungal drug

Outcome Measures

Primary Outcomes (1)

Rate of complete cure at 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.
Baseline - Week 60

Secondary Outcomes (2)

Responder rate at Week 60
Baseline - Week 60
Mycological cure rate at Week 60
Baseline - Week 60

Other Outcomes (2)

Negative culture rate for dermatophytes of the target nail at Week 60
Baseline - Week 60
Onychomycosis quality of life
Baseline - Week 48, Week 60

Study Arms (2)

P-3058

EXPERIMENTAL

Drug: P-3058 (terbinafine hydrochloride 10%)

Vehicle

PLACEBO COMPARATOR

Drug: Vehicle of P-3058

Interventions

P-3058 (terbinafine hydrochloride 10%)Drug

Patients will apply the P-3058 nail solution once weekly in a double blind fashion. The overall treatment phase is of 48 weeks.

P-3058

Vehicle of P-3058Drug

Patients will apply the Vehicle of P-3058 once weekly in a double blind fashion. The overall treatment phase is of 48 weeks.

Vehicle

Eligibility Criteria

Age12 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Written informed consent before starting any study related procedures.
Patients aged 12 and older of any race.

Sponsors & Collaborators

Polichem S.A.
Industrylead
Almirall, S.A.
Industrycollaborator

Study Sites (26)

Polichem Investigation Site no 45

North Hollywood, California, 91606, United States

Polichem Investigation Site no 5

Oceanside, California, 92056, United States

Polichem Investigation Site no 39

San Diego, California, 92123, United States

Polichem Investigation Site no 2

Hialeah, Florida, 33012, United States

Polichem Investigation Site no 23

Jacksonville, Florida, 32204, United States

Polichem Investigation Site no 22

Miami, Florida, 33176, United States

Polichem Investigation Site no 52

Study Officials

Maurizio Caserini, MD
Polichem SA
STUDY DIRECTOR

Enrollment

0 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details: Double blind
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 21, 2017

First Posted

March 29, 2017

Study Start

May 2017

Estimated (date passed)

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Other Outcomes (2)

Study Arms (2)

P-3058

Vehicle

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (26)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Other Outcomes (2)

Study Arms (2)

P-3058

Vehicle

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (26)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations