Topical Penlac Nail Lacquer for Onychomycosis in Children
A Prospective, Double-blind, Placebo-controlled Trial of Topical Penlac Nail Lacquer for Therapy of Onychomycosis in Children
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Mar 2002
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 17, 2011
CompletedFirst Posted
Study publicly available on registry
August 18, 2011
CompletedAugust 18, 2011
May 1, 2006
3.8 years
August 17, 2011
August 17, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Mycological cure or global evaluation of 2 or less Mycological Cure
Week 20
Secondary Outcomes (1)
Estimated cost of therapy
Study Arms (2)
topical Penlac nail lacquer
ACTIVE COMPARATOR3-1 randomization of active to placebo
Placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital-San Diego
San Diego, California, 92123, United States
Related Publications (1)
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.
PMID: 23278851DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sheila F Friedlander, MD
Rady Children's Hospital, San Diego
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 17, 2011
First Posted
August 18, 2011
Study Start
March 1, 2002
Primary Completion
December 1, 2005
Study Completion
May 1, 2006
Last Updated
August 18, 2011
Record last verified: 2006-05