Status:
COMPLETED
Topical Penlac Nail Lacquer for Onychomycosis in Children
Lead Sponsor:
Rady Children's Hospital, San Diego
Conditions:
Onychomycosis
Eligibility:
All Genders
2-16 years
Phase:
PHASE4
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 pr...
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 Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2006
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01419847
Start Date
March 1 2002
End Date
May 1 2006
Last Update
August 18 2011
Active Locations (1)
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1
Children's Hospital-San Diego
San Diego, California, United States, 92123