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Topical Penlac Nail Lacquer for Onychomycosis in Children

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ClinicalTrials.gov Identifier: NCT01419847
Recruitment Status : Completed
First Posted : August 18, 2011
Last Update Posted : August 18, 2011
Sponsor:
Information provided by:
Rady Children's Hospital, San Diego

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : March 2002
Actual Primary Completion Date : December 2005
Actual Study Completion Date : May 2006

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Arms and Interventions
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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
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Primary Outcome Measures :
  1. Mycological cure or global evaluation of 2 or less Mycological Cure [ Time Frame: Week 20 ]

Secondary Outcome Measures :
  1. Estimated cost of therapy

Eligibility Criteria
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Ages Eligible for Study:   2 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01419847


Locations
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United States, California
Children's Hospital-San Diego
San Diego, California, United States, 92123
Sponsors and Collaborators
Rady Children's Hospital, San Diego
Investigators
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Principal Investigator: Sheila F Friedlander, MD Rady Children's Hospital, San Diego
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sheila F. Frieldander, MD; PI, Rady Children's Hopsital, San Diego
ClinicalTrials.gov Identifier: NCT01419847    
Other Study ID Numbers: 02082C (10856)
First Posted: August 18, 2011    Key Record Dates
Last Update Posted: August 18, 2011
Last Verified: May 2006
Additional relevant MeSH terms:
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Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
 Nail Diseases
Skin Diseases
Ciclopirox
Antifungal Agents
Anti-Infective Agents