Onychomycosis MedDRA version: 16.1 Level: PT Classification code 10030338 Term: Onychomycosis System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: terbinafine hydrochloride
Product Code: P-3058
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: TERBINAFINE HYDROCHLORIDE
CAS Number: 78628-80-5
Current Sponsor code: P-3058
Sponsors
Polichem S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written Informed Consent given by the patient and parents/Guardians and in any case before starting any study related procedures; 2. Patients of both genders, aged between 2 and 17 years at the time of the written informed consent with established clinical diagnosis of mild-to-moderate distal sub-ungual onychomycosis (DSO) without spikes/dermatophytoma and without lunula involvement or white superficial onychomycosis (WSO); 3. Patients with positive KOH examination from the target nail chosen at screening; 4. Patients with positive culture for dermatophyte from the target nail chosen at screening. Are the trial subjects under 18? yes Number of subjects for this age range: 35 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients with history of allergic reactions to terbinafine and/or to any of the other ingredients of P-3058; 2. Patients with history of cardiovascular, renal, neurologic, liver, immunologic or endocrine dysfunction if they are clinically significant; 3. Patients with onychomycosis caused by yeasts or nondermatophytes mould; 4. Patients with severe plantar or moccasin tinea pedis (defined by blistering, pustules or inability to ambulate). Patients with mildto-moderate tinea pedis using a topical antifungal treatment will be included; 5. Congenital or acquired nail dystrophy (i.e. Darier’s disease); 6. Patients with nail psoriasis; 7. Patients with nail changes due to eczema, lichen planus or alopecia areata; 8. Patients with one-hand two-foot syndrome; 9. Patients with immunodeficiency disorder or use of immune suppressive therapy 3 months prior to screening visit or need for it; 10. Use of systemic antifungal drugs in the 6 months prior to screening visit; 11. Use of topical nail antifungal drugs in the four weeks prior to screening visit; 12. Habitual finger sucking during the night in children that have fingernail onychomycosis if it cannot be prevented by parents; 13. Female subjects physiologically capable of becoming pregnant are asked to refrain from any sexual intercourse during the whole study duration or to use acceptable methods of contraception agreed with the investigator; 14. Female subjects who are pregnant, nursing mothers, those planning a pregnancy during the course of the study or who become pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: - Overall safety evaluation by recording all adverse event occurring during the study; - Acceptance of therapy by children/Parents or Guardians at the end of treatment; - Complete cure defined as composite of negative KOH microscopy and negative culture for dermatophytes and no residual clinical involvement of the target nail at all study visits; - Responder rate defined as negative KOH microscopy and negative culture for dermatophytes and =10% residual involvement of the target nail at all study visits; - Conversion to negative KOH microscopy at all study visits; - Conversion to negative culture for dermatophytes at all study visits; - Conversion to negative mycology (combination of negative KOH microscopy and negative dermatophytes culture); - Rate of patients having diseased nail =10% or 0% (Clinical Cure); - Decrease of the target nail area at all study visits; - Time to reach the efficacy outcome cure/responder rate.;Primary end point(s): Local tolerability at the application site (all treated nails) during the study period by means of the Severity Score for Skin Irritation.;Timepoint(s) of evaluation of this end point: During the study.;Main Objective: To evaluate the tolerability and safety of topical treatment with P-3058 10% o.w. in pediatric patients with onychomycosis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Overall safety evaluation by recording all adverse event occurring during the study; - Acceptance of therapy by children/Parents or Guardians at the end of treatment; - Complete cure defined as composite of negative KOH microscopy and negative culture for dermatophytes and no residual clinical involvement of the target nail at all study visits; - Responder rate defined as negative KOH microscopy and negative culture for dermatophytes and =10% residual involvement of the target nail at all study visits; - Conversion to negative KOH microscopy at all study visits; - Conversion to negative culture for dermatophytes at all study visits; - Conversion to negative mycology (combination of negative KOH microscopy and negative dermatophytes culture); - Rate of patients having diseased nail =10% or 0% (Clinical Cure); - Decrease of the target nail area at all study visits; - Time to reach the efficacy outcome cure/responder rate.;Timepoint(s) of evaluation of this end point: - during the study; - at the end of treatment; - at all study visits; - at all study visits; - at all study visits; - at all study visits; - during the study; - during the study; - at all study visits; - during the study. | — |
Countries
Belgium, Germany, Italy, Latvia, Spain
Contacts
Public ContactDirector, Clinical Development
Polichem S.A.
Outcome results
None listed