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

Onychomycosis of Toenail Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03094468
• Other study ID #: PM1328
• Status: Withdrawn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
• 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• Status: Withdrawn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.

Related Conditions & MeSH terms

• Onychomycosis
• Onychomycosis of Toenail

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