Topical Penlac Nail Lacquer for Onychomycosis in Children

Sponsor

Rady Children's Hospital, San Diego (Other)

Overall Status

Completed

CT.gov ID

NCT01419847

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Onychomycosis	Drug: Ciclopirox Drug: Placebo	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2002

Actual Primary Completion Date :

Dec 1, 2005

Actual Study Completion Date :

May 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: topical Penlac nail lacquer 3-1 randomization of active to placebo	Drug: Ciclopirox
Placebo Comparator: Placebo	Drug: Placebo

Arm

Intervention/Treatment

Active Comparator: topical Penlac nail lacquer

3-1 randomization of active to placebo

Drug: Ciclopirox

Placebo Comparator: Placebo

Drug: Placebo

Outcome Measures

Primary Outcome Measures

Mycological cure or global evaluation of 2 or less Mycological Cure [Week 20]

Secondary Outcome Measures

Estimated cost of therapy []

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 16 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital-San Diego	San Diego	California	United States	92123

Sponsors and Collaborators

Rady Children's Hospital, San Diego

Investigators

Principal Investigator: Sheila F Friedlander, MD, Rady Children's Hospital, San Diego

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01419847

Other Study ID Numbers:

02082C (10856)

First Posted:

Aug 18, 2011

Last Update Posted:

Aug 18, 2011

Last Verified:

May 1, 2006

Additional relevant MeSH terms:

Onychomycosis

Ciclopirox

Study Results

No Results Posted as of Aug 18, 2011