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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

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 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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



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


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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)
First Posted: August 18, 2011    Key Record Dates
Last Update Posted: August 18, 2011
Last Verified: May 2006

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