Safety and Pharmacokinetics of Terbinafine Hydrogen Chloride (HCl) Nail Lacquer in Patients With Onychomycosis
|Onychomycosis/Onycholysis and Tinea Pedis||Drug: Placebo Drug: Terbinafine Hydrochloride Drug: Terbinafine||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- The primary safety objective was to determine the safety of 10% Terbinafine HCl Nail Lacquer by assessing local and systemic adverse experiences, changes in vital signs, clinical laboratory test results, physical examinations, and electrocardiogram (ECG) [ Time Frame: 28 Days ]
- To determine plasma levels of terbinafine and its metabolites after administration of 10% Terbinafine HCl Nail Lacquer to toenails, 1% Lamisil® Cream to the infected (i.e., tinea pedis) area of the foot and a single Lamisil® Tablet (250 mg) on Day 35. [ Time Frame: 3, 7, 14, 21 and 28 days and Day 35 ]
|Study Start Date:||February 2005|
|Study Completion Date:||December 2005|
|Primary Completion Date:||June 2005 (Final data collection date for primary outcome measure)|
Experimental: Group 1
0% Terbinafine HCl Nail Lacquer for 28 days.
0% Terbinafine HCl Nail Lacquer for onychomycosis, twice daily for 28 days.
Experimental: Group 2
10% Terbinafine HCl Nail Lacquer.
Drug: Terbinafine Hydrochloride
10% Terbinafine HCl Nail Lacquer for onychomycosis, twice daily for 28 days.
Active Comparator: Group 3
1% Lamisil® Cream
Drug: Terbinafine Hydrochloride
1% Terbinafine Hydrochloride Cream, twice a day for 7 days.
Other Name: Lamisil® Cream, 1%
Active Comparator: Group 4
Dose of 250 mg Lamisil® Tablets (Groups 1,2,3) at end of study.
Terbinafine tablet, 250mg, single dose in groups 1,2 and 3 at end of study.
Other Name: Lamisil, 250mg tablet
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00691184
|United States, New Jersey|
|TKL Research Inc.|
|Paramus, New Jersey, United States, 07652|
|Study Director:||Ming Q Lu, MD., Ph.D.||NexMed (U.S.A.), Inc.|