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Topical Penlac Nail Lacquer for Onychomycosis in Children

Primary Purpose

Onychomycosis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ciclopirox
Placebo
Sponsored by
Rady Children's Hospital, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Onychomycosis

Eligibility Criteria

2 Years - 16 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Children's Hospital-San Diego

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

topical Penlac nail lacquer

Placebo

Arm Description

3-1 randomization of active to placebo

Outcomes

Primary Outcome Measures

Mycological cure or global evaluation of 2 or less Mycological Cure

Secondary Outcome Measures

Estimated cost of therapy

Full Information

First Posted
August 17, 2011
Last Updated
August 17, 2011
Sponsor
Rady Children's Hospital, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT01419847
Brief Title
Topical Penlac Nail Lacquer for Onychomycosis in Children
Official Title
A Prospective, Double-blind, Placebo-controlled Trial of Topical Penlac Nail Lacquer for Therapy of Onychomycosis in Children
Study Type
Interventional

2. Study Status

Record Verification Date
May 2006
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
May 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Rady Children's Hospital, San Diego

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
topical Penlac nail lacquer
Arm Type
Active Comparator
Arm Description
3-1 randomization of active to placebo
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ciclopirox
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Mycological cure or global evaluation of 2 or less Mycological Cure
Time Frame
Week 20
Secondary Outcome Measure Information:
Title
Estimated cost of therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheila F Friedlander, MD
Organizational Affiliation
Rady Children's Hospital, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital-San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23278851
Citation
Friedlander SF, Chan YC, Chan YH, Eichenfield LF. Onychomycosis does not always require systemic treatment for cure: a trial using topical therapy. Pediatr Dermatol. 2013 May-Jun;30(3):316-22. doi: 10.1111/pde.12064. Epub 2012 Dec 28.
Results Reference
derived

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Topical Penlac Nail Lacquer for Onychomycosis in Children

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