Topical Penlac Nail Lacquer for Onychomycosis in Children

August 17, 2011 updated by: Rady Children's Hospital, San Diego

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92123
        • Children's Hospital-San Diego

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mycological cure or global evaluation of 2 or less Mycological Cure
Time Frame: Week 20
Week 20

Secondary Outcome Measures

Outcome Measure
Estimated cost of therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rady Children's Hospital, San Diego

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

August 17, 2011

First Submitted That Met QC Criteria

August 17, 2011

First Posted (Estimate)

August 18, 2011

Study Record Updates

Last Update Posted (Estimate)

August 18, 2011

Last Update Submitted That Met QC Criteria

August 17, 2011

Last Verified

May 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02082C (10856)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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