Clinical trial NCT02549001: Study to Evaluate the Efficacy and Safety of P-3058 10% Nail Solution in the Treatment of Toenail 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Onychomycosis
Keywords: Onychomycosis
Nail fungus
Lead sponsor: Polichem S.A.
Sponsor class: INDUSTRY
First posted: 2015-09-14
Enrollment: 953
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Complete cure of target great toenail defined as negative KOH microscopy, negative culture for dermatophytes and target nail totally clear.
timeFrame: Week 60
Secondary outcomes:
measure: Responder rate of the target toenail, defined as negative KOH microscopy, negative culture for dermatophytes and ≤10% residual involvement of the target toenail.
timeFrame: Week 60
measure: Negative culture rate for dermatophytes of the target nail.
timeFrame: Week 60
measure: Mycological cure defined as negative KOH microscopy and negative culture for dermatophytes of the target nail.
timeFrame: Week 60
measure: Overall safety by recording any AE during the entire study duration and the local tolerability by means of severity scores for skin irritation.
timeFrame: Week 60
Other outcomes:
Locations:
city: Multiple Locations
country: Belgium
facility: Polichem Investigative Site
city: Multiple Locations
country: Bulgaria
facility: Polichem Investigative Site
city: Multiple Locations
country: Czechia
facility: Polichem Investigative Site
city: Multiple Locations
country: Germany
facility: Polichem Investigative Site
city: Multiple Locations
country: Greece
facility: Polichem Investigative Site
city: Multiple Locations
country: Hungary
facility: Polichem Investigative Site
city: Various Cities In Iceland
country: Iceland
facility: Polichem Investigative Site
city: Multiple Locations
country: Latvia
facility: Polichem Investigative Site
city: Multiple Locations
country: Lithuania
facility: Polichem Investigative Site
city: Multiple Locations
country: Poland
facility: Polichem Investigative Site
city: Multiple Locations
country: Russian Federation
facility: Polichem Investigative Site
city: Multiple Locations
country: Slovakia
facility: Polichem Investigative Site
city: Multiple Locations
country: Sweden
facility: Polichem Investigative Site
Study officials:
affiliation: Polichem S.A.
name: Maurizio Caserini, MD
role: STUDY_DIRECTOR
References: