Clinical Trial on Onychomycosis With P-3058 Nail Solution in Pediatric Population

Launched by POLICHEM S.A. · Sep 10, 2015

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

• 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.