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

NCT03094468 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: PM1328
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 26

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.

Conditions

Onychomycosis of Toenail

Keywords

terbinafine nail solution; nail fungal infection; topical 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-3058 DRUG

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

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (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.
• Males or females.
• Outpatients.
• Clinically diagnosed mild-to-moderate distal lateral subungual onychomycosis (DLSO) of at least one great toenail (the "target nail") at the Screening visit (V1).
• Patients with onychomycosis involving ≥ 20% to ≤ 50% of the area of the target great toenail.
• Patients with a positive KOH examination.
• Patients with positive culture for dermatophyte(s).
• Evidence of target great toenail growth reported by the patient defined as at least monthly nail clipping.

You may not qualify if:

• Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period.
• Patients with history of allergic reactions to terbinafine or its excipients.
• Use of any investigational drug/device or participation in a previous clinical trial within four weeks prior to Screening visit (V1).
• Patients using nail polish or other nail cosmetic product on the concerned nails from at least 24 hours prior to Screening visit (V1) until the end of the study.
• Use of systemic antifungal drugs in the 24 weeks prior to Screening visit (V1) or non-responsive to systemic antifungal therapy for onychomycosis.
• Nail application of topical antifungal drugs or device in the 4 weeks prior to Screening visit (V1).
• Presence of any nail infections other than dermatophyte.
• Presence of onychodystrophy that could interfere with clinical assessments.
• 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 (marker of immunosuppressed patient).
• Patients with severe plantar or moccasin tinea pedis (defined by blistering, pustules or inability to ambulate).
• Patients with nail abnormalities due to conditions like psoriasis, lichen planus, immune dysfunction, collagen-vascular diseases, peripheral vascular disease.
• Patients with life expectancy less than 2 years.

Sponsors & Collaborators

• Polichem S.A.: lead
• Almirall, S.A.: collaborator

Study Sites (26)

Polichem Investigation Site no 45

North Hollywood, California, 91606, United States

Location

Polichem Investigation Site no 5

Oceanside, California, 92056, United States

Location

Polichem Investigation Site no 39

San Diego, California, 92123, United States

Location

Polichem Investigation Site no 2

Hialeah, Florida, 33012, United States

Location

Polichem Investigation Site no 23

Jacksonville, Florida, 32204, United States

Location

Polichem Investigation Site no 22

Miami, Florida, 33176, United States

Location

Polichem Investigation Site no 52

Louisville, Kentucky, 40202, United States

Location

Polichem Investigation Site no 41

Portsmouth, New Hampshire, 03801, United States

Location

Polichem Investigation site no 1

New York, New York, 10025, United States

Location

Polichem Investigation Site no 44

Cincinnati, Ohio, 45249, United States

Location

Polichem Investigation Site no 40

Norman, Oklahoma, 71071, United States

Location

Polichem Investigation Site no 14

Oklahoma City, Oklahoma, 73103, United States

Location

Polichem Investigation Site no 10

Austin, Texas, 78731, United States

Location

Polichem Investigation Site no 11

Dallas, Texas, 75234, United States

Location

Polichem Investigation Site no 43

Dallas, Texas, 75246, United States

Location

Polichem Investigation Site no 6

Fort Worth, Texas, 76107, United States

Location

Polichem Investigation Site no 12

Houston, Texas, 77055, United States

Location

Polichem Investigation Site no 4

Houston, Texas, 77081, United States

Location

Polichem Investigation Site no 42

Pflugerville, Texas, 78660, United States

Location

Polichem Investigation Site no 53

San Antonio, Texas, 78229, United States

Location

Polichem Investigation Site no 54

San Antonio, Texas, 78249, United States

Location

Polichem Investigation site no 3

Calgary, Alberta, T2G 1B1, Canada

Location

Polichem Investigation Site no 8

Edmonton, Alberta, T5K 1X3, Canada

Location

Polichem Investigation Site no 13

Mississauga, Ontario, L5H 1G9, Canada

Location

Polichem Investigation Site no 9

Richmond Hill, Ontario, L4C 9M7, Canada

Location

Polichem Investigation Site no 7

Toronto, Ontario, M9W 4L6, Canada

Location

Study Officials

• Maurizio Caserini, MD

  Polichem SA

  STUDY DIRECTOR

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

Model Details: Vehicle-controlled

Study Record Dates

• First Submitted: March 21, 2017
• First Posted: March 29, 2017
• Study Start: May 1, 2017
• Primary Completion: October 1, 2019
• Study Completion: December 1, 2019
• Last Updated: January 10, 2018

Record last verified: 2018-01

Locations

CA (5); US (21)