Onychomycosis
Conditions
Brief summary
Pediatric patients affected by mild-to-moderate distal subungual onychomycosis (DSO) or affected by white superficial onychomycosis (WSO), due to dermatophytes, will be treated topically with P-3058 nail solution according to the appropriate treatment schedule.
Interventions
DRUGP-3058
Sponsors
Polichem S.A.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Age between 2 to 17 years * Males and females * Clinical diagnosis of mild-to-moderate distal sub-ungual onychomycosis without spikes/dermatophytoma and without lunula involvement or white superficial onychomycosis. * Positive mycroscopy examination from the target nail at screening. * Positive culture for dermatophyte from the target nail at screening.
Exclusion criteria
* Patients with onychomycosis caused by yeasts or non-dermatophytes mould. * Patients with nail psoriasis. * Patients with nail changes due to eczema, lichen planus or alopecia areata. * Patients with one-hand two-foot syndrome. * Patients with immunodeficiency disorder or use of immune suppressive therapy 3 months prior to screening visit or need for it. * Use of systemic antifungal drugs in the 6 months prior to screening visit. * Use of topical nail antifungal drugs in the four weeks prior to screening visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local tolerability | from week 4 up to maximum week 48 of treatment | Local tolerability at all treated nails by means of the Severity Score for Skin Irritation |
Countries
Belgium, Germany, Italy, Latvia, Spain
Outcome results
None listed