Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
NexMed, Inc. |
---|---|
Information provided by: | NexMed, Inc. |
ClinicalTrials.gov Identifier: | NCT00691184 |
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
Condition | Intervention | Phase |
---|---|---|
Onychomycosis/Onycholysis and Tinea Pedis |
Drug: Placebo Drug: Terbinafine Hydrochloride Drug: Terbinafine Hydrochloride Drug: Terbinafine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Pharmacokinetics Study |
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 |
Enrollment: | 56 |
Study Start Date: | February 2005 |
Study Completion Date: | December 2005 |
Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Group 1: Experimental
0% Terbinafine HCl Nail Lacquer for 28 days.
|
Drug: Placebo
0% Terbinafine HCl Nail Lacquer for onychomycosis, twice daily for 28 days.
|
Group 2: Experimental
10% Terbinafine HCl Nail Lacquer.
|
Drug: Terbinafine Hydrochloride
10% Terbinafine HCl Nail Lacquer for onychomycosis, twice daily for 28 days.
|
Group 3: Active Comparator
1% Lamisil® Cream
|
Drug: Terbinafine Hydrochloride
1% Terbinafine Hydrochloride Cream, twice a day for 7 days.
|
Group 4: Active Comparator
Dose of 250 mg Lamisil® Tablets (Groups 1,2,3) at end of study.
|
Drug: Terbinafine
Terbinafine tablet, 250mg, single dose in groups 1,2 and 3 at end of study.
|
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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients were required to meet all of the following criteria in order to be eligible for entry in the study:
Exclusion Criteria:
Any of the following excluded a patient from participating in the study:
Other protocol-defined inclusion/exclusion criteria may apply.
Study ID Numbers: | NM-060-1001 |
Study First Received: | June 3, 2008 |
Last Updated: | June 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00691184 |
Health Authority: | United States: Food and Drug Administration |
Onychomycosis, Toenail fungal infection, Terbinafine HCl, Pharmacokinetics |
Pruritus Skin Diseases Clotrimazole Miconazole Tioconazole Foot Diseases Onycholysis Mycoses |
Tinea Pedis Signs and Symptoms Skin Diseases, Infectious Onychomycosis Tinea Dermatomycoses Terbinafine |
Anti-Infective Agents Skin Manifestations Nail Diseases Foot Dermatoses Molecular Mechanisms of Pharmacological Action |
Therapeutic Uses Antifungal Agents Enzyme Inhibitors Infection Pharmacologic Actions |