Topical Penlac Nail Lacquer for Onychomycosis in Children

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rady Children's Hospital, San Diego
• Treatments: Ciclopirox

Criteria

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