Clinical Trial on Onychomycosis With P-3058 Nail Solution in Pediatric Population
- Registration Number
- NCT02547701
- Lead Sponsor
- Polichem S.A.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description P-3058 P-3058 -
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Polichem Investigative site
🇮🇹One Investigational Site, Italy
Polichem Investigative Site
🇪🇸One Investigational Site, Spain