Topical Penlac Nail Lacquer for Onychomycosis in Children

A Prospective, Double-blind, Placebo-controlled Trial of Topical Penlac Nail Lacquer for Therapy of Onychomycosis in Children

Five months of therapy is sufficient to treat onychomycosis in children. Topical therapy of onychomycosis in children with Penlac nail lacquer has comparable efficacy and a superior cost and safety profile compared to systemic therapy.

Therapeutic trials for the treatment of onychomycosis have been conducted in the adult population, but there is limited data available in the pediatric population.

Inclusion Criteria:

• Children between the ages of two and sixteen years
• Clinical diagnosis of toenail onychomycosis involving at least 20% of one nail plate
• Positive DTM reading or fungal culture for onychomycosis-either dermatophytes or non-dermatophyte mold
• Consent to participate in the study
• Women of child-bearing potential must have a negative urine pregnancy test at the baseline visit and be willing to practice effective contraception for the duration of the study.

Exclusion Criteria:

• Children with allergy to Penlac or one of its ingredients
• Structural deformity of target nail plate
• Presence of active psoriasis or severe foot eczema
• Presence of immunodeficiency disorder
• Concurrent immune suppressive therapy or immune suppressive therapy within the last 3 months
• Previous systemic antifungal therapy within the last 6 months
• Previous topical antifungal therapy within the last 14 days
• Female subjects who are pregnant, nursing mothers, those planning a pregnancy during the course of the study, or who become pregnant