Study to Evaluate the Efficacy and Safety of P-3058 Nail Solution in the Treatment of Onychomycosis
Primary Purpose
Onychomycosis of Toenail
Status
Withdrawn
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
P-3058 (terbinafine hydrochloride 10%)
Vehicle of P-3058
Sponsored by
About this trial
This is an interventional treatment trial for Onychomycosis of Toenail focused on measuring terbinafine nail solution, nail fungal infection, topical antifungal drug
Eligibility Criteria
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.
Sites / Locations
- Polichem Investigation Site no 45
- Polichem Investigation Site no 5
- Polichem Investigation Site no 39
- Polichem Investigation Site no 2
- Polichem Investigation Site no 23
- Polichem Investigation Site no 22
- Polichem Investigation Site no 52
- Polichem Investigation Site no 41
- Polichem Investigation site no 1
- Polichem Investigation Site no 44
- Polichem Investigation Site no 40
- Polichem Investigation Site no 14
- Polichem Investigation Site no 10
- Polichem Investigation Site no 11
- Polichem Investigation Site no 43
- Polichem Investigation Site no 6
- Polichem Investigation Site no 12
- Polichem Investigation Site no 4
- Polichem Investigation Site no 42
- Polichem Investigation Site no 53
- Polichem Investigation Site no 54
- Polichem Investigation site no 3
- Polichem Investigation Site no 8
- Polichem Investigation Site no 13
- Polichem Investigation Site no 9
- Polichem Investigation Site no 7
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
P-3058
Vehicle
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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)
Mycological cure rate at Week 60
Defined as negative Potassium Hydroxide (KOH) microscopy and negative culture for dermatophytes of the target nail.
Full Information
NCT ID
NCT03094468
First Posted
March 21, 2017
Last Updated
January 9, 2018
Sponsor
Polichem S.A.
Collaborators
Almirall, S.A.
1. Study Identification
Unique Protocol Identification Number
NCT03094468
Brief Title
Study to Evaluate the Efficacy and Safety of P-3058 Nail Solution in the Treatment of Onychomycosis
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Project development priorities changed
Study Start Date
May 2017 (Anticipated)
Primary Completion Date
October 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Polichem S.A.
Collaborators
Almirall, S.A.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis of Toenail
Keywords
terbinafine nail solution, nail fungal infection, topical antifungal drug
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Vehicle-controlled
Masking
ParticipantCare ProviderInvestigator
Masking Description
Double blind
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
P-3058
Arm Type
Experimental
Arm Title
Vehicle
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
P-3058 (terbinafine hydrochloride 10%)
Intervention Description
Patients will apply the P-3058 nail solution once weekly in a double blind fashion. The overall treatment phase is of 48 weeks.
Intervention Type
Drug
Intervention Name(s)
Vehicle of P-3058
Intervention Description
Patients will apply the Vehicle of P-3058 once weekly in a double blind fashion. The overall treatment phase is of 48 weeks.
Primary Outcome Measure Information:
Title
Rate of complete cure at Week 60
Description
Defined as composite of negative KOH microscopy and negative culture for dermatophytes and no residual clinical involvement (nail totally clear) of the target nail.
Time Frame
Baseline - Week 60
Secondary Outcome Measure Information:
Title
Responder rate at Week 60
Description
Defined as negative Potassium Hydroxide (KOH) microscopy and negative culture for dermatophytes and ≤ 10% residual involvement of the target toenail)
Time Frame
Baseline - Week 60
Title
Mycological cure rate at Week 60
Description
Defined as negative Potassium Hydroxide (KOH) microscopy and negative culture for dermatophytes of the target nail.
Time Frame
Baseline - Week 60
Other Pre-specified Outcome Measures:
Title
Negative culture rate for dermatophytes of the target nail at Week 60
Time Frame
Baseline - Week 60
Title
Onychomycosis quality of life
Description
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.
Time Frame
Baseline - Week 48, Week 60
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maurizio Caserini, MD
Organizational Affiliation
Polichem SA
Official's Role
Study Director
Facility Information:
Facility Name
Polichem Investigation Site no 45
City
North Hollywood
State/Province
California
ZIP/Postal Code
91606
Country
United States
Facility Name
Polichem Investigation Site no 5
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Polichem Investigation Site no 39
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Polichem Investigation Site no 2
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Polichem Investigation Site no 23
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Polichem Investigation Site no 22
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Polichem Investigation Site no 52
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Polichem Investigation Site no 41
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Facility Name
Polichem Investigation site no 1
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Facility Name
Polichem Investigation Site no 44
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45249
Country
United States
Facility Name
Polichem Investigation Site no 40
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
71071
Country
United States
Facility Name
Polichem Investigation Site no 14
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Polichem Investigation Site no 10
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Polichem Investigation Site no 11
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
Polichem Investigation Site no 43
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Polichem Investigation Site no 6
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76107
Country
United States
Facility Name
Polichem Investigation Site no 12
City
Houston
State/Province
Texas
ZIP/Postal Code
77055
Country
United States
Facility Name
Polichem Investigation Site no 4
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Facility Name
Polichem Investigation Site no 42
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
Polichem Investigation Site no 53
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Polichem Investigation Site no 54
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78249
Country
United States
Facility Name
Polichem Investigation site no 3
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2G 1B1
Country
Canada
Facility Name
Polichem Investigation Site no 8
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5K 1X3
Country
Canada
Facility Name
Polichem Investigation Site no 13
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5H 1G9
Country
Canada
Facility Name
Polichem Investigation Site no 9
City
Richmond Hill
State/Province
Ontario
ZIP/Postal Code
L4C 9M7
Country
Canada
Facility Name
Polichem Investigation Site no 7
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9W 4L6
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Study to Evaluate the Efficacy and Safety of P-3058 Nail Solution in the Treatment of Onychomycosis
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