NCT02549001

Brief Summary

The purpose of this study is to determine whether P-3058 nail solution is a safe and effective treatment for onychomycosis.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
953

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Aug 2015

Typical duration for phase_3

Geographic Reach
13 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 20, 2015

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 14, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 17, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2018

Completed
Last Updated

September 26, 2018

Status Verified

September 1, 2018

Enrollment Period

3.1 years

First QC Date

September 8, 2015

Last Update Submit

September 25, 2018

Conditions

Onychomycosis

Keywords

OnychomycosisNail fungus

Outcome Measures

Primary Outcomes (1)

  • Complete cure of target great toenail defined as negative KOH microscopy, negative culture for dermatophytes and target nail totally clear.

    Week 60

Secondary Outcomes (4)

  • Responder rate of the target toenail, defined as negative KOH microscopy, negative culture for dermatophytes and ≤10% residual involvement of the target toenail.

    Week 60

  • Negative culture rate for dermatophytes of the target nail.

    Week 60

  • Mycological cure defined as negative KOH microscopy and negative culture for dermatophytes of the target nail.

    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.

    Week 60

Study Arms (3)

P-3058 10%

EXPERIMENTAL

P-3058 10%

Drug: P-3058 10%

vehicle of P-3058 10%

PLACEBO COMPARATOR

vehicle of P-3058 10%

Drug: vehicle of P-3058 10%

amorolfine 5%

ACTIVE COMPARATOR

Loceryl®

Drug: amorolfine 5%

Interventions

P-3058 10%DRUG
P-3058 10%
vehicle of P-3058 10%DRUG
vehicle of P-3058 10%
amorolfine 5%DRUG
Also known as: Loceryl®
amorolfine 5%

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent
  • Patients aged 12 years and older of any race.
  • Males or females.
  • Patients with onychomycosis involving ≥ 20% to ≤ 50% of target big toenail.
  • Patients with a positive KOH examination and culture positive for dermatophyte

You may not qualify if:

  • Presence of "yellow spikes" on the target nail.
  • Presence of dermatophytoma on the target nail.
  • Presence of nail thickness exceeding 2 mm.
  • Patients with proximal subungual involvement
  • Patients with severe plantar or moccasin tinea pedis
  • Patients with nail abnormalities due to other conditions
  • Patients with life expectancy less than 2 years.
  • Chemotherapy, immunosuppressive therapy in the 12 weeks prior to Screening visit (V1).
  • Systemic corticosteroids, antimetabolites and immune-stimulants therapy in the 4 weeks prior to Screening visit (V1).
  • HIV infection or any other immunodeficiency.
  • Alcohol or substance abuse.
  • Patients with history of allergic reactions to terbinafine or its excipients.
  • Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Polichem Investigative Site

Multiple Locations, Belgium

Location

Polichem Investigative Site

Multiple Locations, Bulgaria

Location

Polichem Investigative Site

Multiple Locations, Czechia

Location

Polichem Investigative Site

Multiple Locations, Germany

Location

Polichem Investigative Site

Multiple Locations, Greece

Location

Polichem Investigative Site

Multiple Locations, Hungary

Location

Polichem Investigative Site

Various Cities in Iceland, Iceland

Location

Polichem Investigative Site

Multiple Locations, Latvia

Location

Polichem Investigative Site

Multiple Locations, Lithuania

Location

Polichem Investigative Site

Multiple Locations, Poland

Location

Polichem Investigative Site

Multiple Locations, Russia

Location

Polichem Investigative Site

Multiple Locations, Slovakia

Location

Polichem Investigative Site

Multiple Locations, Sweden

Location

MeSH Terms

Conditions

Onychomycosis

Interventions

amorolfine

Condition Hierarchy (Ancestors)

TineaDermatomycosesMycosesBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousNail DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Maurizio Caserini, MD

    Polichem S.A.

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

September 8, 2015

First Posted

September 14, 2015

Study Start

August 20, 2015

Primary Completion

September 17, 2018

Study Completion

September 17, 2018

Last Updated

September 26, 2018

Record last verified: 2018-09

Locations

IC(1)BU(1)CZ(1)DE(1)HU(1)BE(1)LA(1)SL(1)PL(1)GR(1)LI(1)RU(1)SE(1)