Safety and Pharmacokinetics of Terbinafine Hydrogen Chloride (HCl) Nail Lacquer in Patients With Onychomycosis
Condition: Onychomycosis/Onycholysis and Tinea Pedis
MeSH terms: Onychomycosis; Tinea Pedis; Onycholysis
Study type: Interventional
Phase: Phase 1

Summary: 
      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
    

Detailed description: 
      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.
    

Intervention name(s): Placebo; Terbinafine Hydrochloride; Terbinafine Hydrochloride; Terbinafine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 0% Terbinafine HCl Nail Lacquer for onychomycosis, twice daily for 28 days.; 10% Terbinafine HCl Nail Lacquer for onychomycosis, twice daily for 28 days.; 1% Terbinafine Hydrochloride Cream, twice a day for 7 days.; Terbinafine tablet, 250mg, single dose in groups 1,2 and 3 at end of study.
Other intervention name(s): Lamisil® Cream, 1%; Lamisil, 250mg tablet
Intervention MeSH terms: Terbinafine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Onychomycosis, Toenail fungal infection, Terbinafine HCl, Pharmacokinetics