Topical Penlac Nail Lacquer for Onychomycosis in Children

Completed · Phase 4 · Has a placebo group

Conditions studied: Onychomycosis

In brief

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.

Key facts

Study ID

NCT01419847

Run by

Rady Children's Hospital, San Diego

People needed

40

Starts

2002-03-01

Expected to finish

2006-05-01

Last updated by the study team

2011-08-18

Who can join

Age: 2 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Children's Hospital-San Diego — San Diego, California, United States

Full record on ClinicalTrials.gov

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