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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01419847

Enrollment

Registered

2011-08-18

Start date

2002-03-31

Completion date

2006-05-31

Last updated

2011-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Onychomycosis

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.

Interventions

DRUGCiclopirox

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

2 Years to 16 Years

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

Design outcomes

Primary

Measure	Time frame
Mycological cure or global evaluation of 2 or less Mycological Cure	Week 20

Secondary

Measure	Time frame
Estimated cost of therapy	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026