Topical Penlac Nail Lacquer for Onychomycosis in Children

This study has been completed.
Sponsor:
Information provided by:
Rady Children's Hospital, San Diego
ClinicalTrials.gov Identifier:
NCT01419847
First received: August 17, 2011
Last updated: NA
Last verified: May 2006
History: No changes posted
  Purpose

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 Intervention Phase
Onychomycosis
Drug: Ciclopirox
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Double-blind, Placebo-controlled Trial of Topical Penlac Nail Lacquer for Therapy of Onychomycosis in Children

Resource links provided by NLM:


Further study details as provided by Rady Children's Hospital, San Diego:

Primary Outcome Measures:
  • Mycological cure or global evaluation of 2 or less Mycological Cure [ Time Frame: Week 20 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Estimated cost of therapy [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: March 2002
Study Completion Date: May 2006
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: topical Penlac nail lacquer
3-1 randomization of active to placebo
Drug: Ciclopirox
Placebo Comparator: Placebo Drug: Placebo

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.

  Eligibility

Ages Eligible for Study:   2 Years to 16 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01419847

Locations
United States, California
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
  More Information

No publications provided by Rady Children's Hospital, San Diego

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sheila F. Frieldander, MD; PI, Rady Children's Hopsital, San Diego
ClinicalTrials.gov Identifier: NCT01419847     History of Changes
Other Study ID Numbers: 02082C (10856)
Study First Received: August 17, 2011
Last Updated: August 17, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Nail Diseases
Skin Diseases
Ciclopirox
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014