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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03094468
Other study ID # PM1328
Secondary ID
Status Withdrawn
Phase Phase 3
First received March 21, 2017
Last updated January 9, 2018
Start date May 2017
Est. completion date December 2019

Study information

Verified date January 2018
Source Polichem S.A.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2019
Est. primary completion date October 2019
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

- 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/parents (or legal guardian) unable to understand the procedures and purposes of the study.

- Any other condition that, in the opinion of the Investigator, would prevent the subject from effectively participating in the study, place the subject at risk or effect the assessment of efficacy and safety of the study medication.

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Canada Polichem Investigation site no 3 Calgary Alberta
Canada Polichem Investigation Site no 8 Edmonton Alberta
Canada Polichem Investigation Site no 13 Mississauga Ontario
Canada Polichem Investigation Site no 9 Richmond Hill Ontario
Canada Polichem Investigation Site no 7 Toronto Ontario
United States Polichem Investigation Site no 10 Austin Texas
United States Polichem Investigation Site no 44 Cincinnati Ohio
United States Polichem Investigation Site no 11 Dallas Texas
United States Polichem Investigation Site no 43 Dallas Texas
United States Polichem Investigation Site no 6 Fort Worth Texas
United States Polichem Investigation Site no 2 Hialeah Florida
United States Polichem Investigation Site no 12 Houston Texas
United States Polichem Investigation Site no 4 Houston Texas
United States Polichem Investigation Site no 23 Jacksonville Florida
United States Polichem Investigation Site no 52 Louisville Kentucky
United States Polichem Investigation Site no 22 Miami Florida
United States Polichem Investigation site no 1 New York New York
United States Polichem Investigation Site no 40 Norman Oklahoma
United States Polichem Investigation Site no 45 North Hollywood California
United States Polichem Investigation Site no 5 Oceanside California
United States Polichem Investigation Site no 14 Oklahoma City Oklahoma
United States Polichem Investigation Site no 42 Pflugerville Texas
United States Polichem Investigation Site no 41 Portsmouth New Hampshire
United States Polichem Investigation Site no 53 San Antonio Texas
United States Polichem Investigation Site no 54 San Antonio Texas
United States Polichem Investigation Site no 39 San Diego California

Sponsors (2)

Lead Sponsor Collaborator
Polichem S.A. Almirall, S.A.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other Negative culture rate for dermatophytes of the target nail at Week 60 Baseline - Week 60
Other Onychomycosis quality of life The questionnaire ONYCHO (Toenail from Mapi Research Trust) will be administered at Week 0, at Week 48 and at Week 60 or at the discontinuation visit. Baseline - Week 48, Week 60
Primary 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 Responder rate at Week 60 Defined as negative Potassium Hydroxide (KOH) microscopy and negative culture for dermatophytes and = 10% residual involvement of the target toenail) Baseline - Week 60
Secondary Mycological cure rate at Week 60 Defined as negative Potassium Hydroxide (KOH) microscopy and negative culture for dermatophytes of the target nail. Baseline - Week 60
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