Onychomycosis/Onycholysis and Tinea Pedis Clinical Trial
Official title:
A Double-Blind, Randomized, Parallel Design Study To Assess the Safety and Pharmacokinetics of Terbinafine Hydrogen Cloride (HCl) Nail Lacquer Applied for 28 Days in Patients With Onychomycosis
In this study, the safety and pharmacokinetics of 10 % terbinafine hydrogen chloride (HCl) nail lacquer wre investigated by comparison with vehicle control and 1% terbinafine cream
This was a double-blind, randomized, parallel-design, placebo-controlled Phase 1 study
comparing 10% Terbinafine HCl Nail Lacquer vs. Placebo Nail Lacquer (i.e., vehicle control).
For comparative purposes, the study also included a contemporaneous assessment of 1%
Lamisil® Cream (1% terbinafine HCl) and Lamisil® Tablets (terbinafine HCl labeled as 250 mg
of terbinafine).
Forty (40) onychomycosis (Groups 1 and 2) and 16 tinea pedis (Group 3) patients were
enrolled at 3 study centers. In Group 1, 10% Terbinafine HCl Nail Lacquer, and, in Group 2,
its vehicle (0% terbinafine HCl), were applied topically by brushing on a dose volume of
approximately 10 μL per nail twice daily for 28 days to each toenail and to 5 mm of adjacent
skin. The patients visited the study center on Days 3, 7, 14, 21, and 28 for assessments of
clinical signs and to obtain blood samples. In addition, a 24-hour urine sample was
collected and assessed on Day 28 and Day 35. Fifty six (56) patients (20 in Group 1, 20 in
Group 2, and 16 in Group 3) received a single oral dose of a 250 mg Lamisil® Tablet after a
7-day washout period.
For comparative purposes, the study also evaluated the local and systemic safety, and plasma
levels of terbinafine, and its 3 major metabolites (i.e., desmethyl terbinafine,
carboxybutyl terbinafine, and desmethyl carboxybutyl terbinafine) following administration
of 1% Lamisil® Cream in comparison with 10% Terbinafine HCl Nail Lacquer. In Group 3,
approximately 0.5 g of 1% Lamisil® Cream was applied twice a day for 7 days to the area of
the foot affected with tinea pedis. The patients visited the study center on Day 3 and on
Day 7 for assessments of clinical signs and collection of blood samples. A 24-hour urine
sample was collected and assessed on Day 7 and Day 14.
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Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment