Topical Penlac Nail Lacquer for Onychomycosis in Children

Onychomycosis Clinical Trial

Official title:

A Prospective, Double-blind, Placebo-controlled Trial of Topical Penlac Nail Lacquer for Therapy of Onychomycosis in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01419847
• Other study ID #: 02082C (10856)
• Status: Completed
• Phase: Phase 4
• First received: August 17, 2011
• Last updated: August 17, 2011
• Start date: March 2002
• Est. completion date: May 2006

Study information

• Verified date: May 2006
• Source: Rady Children's Hospital, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2006
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 16 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Onychomycosis

Intervention

Drug:
• Ciclopirox

• Placebo

Locations

Country	Name	City	State
United States	Children's Hospital-San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Rady Children's Hospital, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mycological cure or global evaluation of 2 or less Mycological Cure		Week 20	No
Secondary	Estimated cost of therapy			No