Topical Penlac Nail Lacquer for Onychomycosis in Children

Phase 4

Completed

• Conditions: Onychomycosis
• Interventions: Drug: Placebo; Drug: Ciclopirox

• Registration Number: NCT01419847
• Lead Sponsor: Rady Children's Hospital, San Diego

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2002-03
• Primary Completion: 2005-12
• Status Verified: 2006-05
• Study Completion: 2006-05
• Study First Submitted: 2011-08-17
• Study First Submitted QC: 2011-08-17
• Last Update Submitted: 2011-08-17
• Study First Posted: 2011-08-18
• Last Update Posted: 2011-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
topical Penlac nail lacquer	Ciclopirox	3-1 randomization of active to placebo

Primary Outcome Measures

Name	Time	Method
Mycological cure or global evaluation of 2 or less Mycological Cure	Week 20

Secondary Outcome Measures

Name	Time	Method
Estimated cost of therapy

Trial Locations

Locations (1)

Children's Hospital-San Diego; 🇺🇸 San Diego, California, United States