Study to Evaluate the Efficacy and Safety of P-3058 10% Nail Solution in the Treatment of Toenail Onychomycosis

Onychomycosis 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: Completed

Administrative data

• NCT number: NCT02549001
• Other study ID #: PM1331
• Secondary ID: 2015-000561-31
• Status: Completed
• Phase: Phase 3
• Start date: August 20, 2015
• Est. completion date: September 17, 2018

Study information

• Verified date: September 2018
• Source: Polichem S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 953
• Est. completion date: September 17, 2018
• Est. primary completion date: September 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Onychomycosis

Intervention

Drug:
• P-3058 10%

• vehicle of P-3058 10%

• amorolfine 5%

Locations

Country	Name	City	State
Belgium	Polichem Investigative Site	Multiple Locations
Bulgaria	Polichem Investigative Site	Multiple Locations
Czechia	Polichem Investigative Site	Multiple Locations
Germany	Polichem Investigative Site	Multiple Locations
Greece	Polichem Investigative Site	Multiple Locations
Hungary	Polichem Investigative Site	Multiple Locations
Iceland	Polichem Investigative Site	Various Cities In Iceland
Latvia	Polichem Investigative Site	Multiple Locations
Lithuania	Polichem Investigative Site	Multiple Locations
Poland	Polichem Investigative Site	Multiple Locations
Russian Federation	Polichem Investigative Site	Multiple Locations
Slovakia	Polichem Investigative Site	Multiple Locations
Sweden	Polichem Investigative Site	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Polichem S.A.

Countries where clinical trial is conducted

Belgium,  Bulgaria,  Czechia,  Germany,  Greece,  Hungary,  Iceland,  Latvia,  Lithuania,  Poland,  Russian Federation,  Slovakia,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete cure of target great toenail defined as negative KOH microscopy, negative culture for dermatophytes and target nail totally clear.		Week 60
Secondary	Responder rate of the target toenail, defined as negative KOH microscopy, negative culture for dermatophytes and =10% residual involvement of the target toenail.		Week 60
Secondary	Negative culture rate for dermatophytes of the target nail.		Week 60
Secondary	Mycological cure defined as negative KOH microscopy and negative culture for dermatophytes of the target nail.		Week 60
Secondary	Overall safety by recording any AE during the entire study duration and the local tolerability by means of severity scores for skin irritation.		Week 60