Topical Penlac Nail Lacquer for Onychomycosis in Children

Rady Children's Hospital

Status and phase

Completed

Phase 4

Conditions

Onychomycosis

Treatments

Drug: Placebo

Drug: Ciclopirox

Study type

Interventional

Funder types

Other

Identifiers

NCT01419847

02082C (10856)

Details and patient eligibility

About

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.

Full description

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

Enrollment

40 patients

Sex

All

Ages

2 to 16 years old

Volunteers

No Healthy Volunteers

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