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

NCT00691184 Phase 1 COMPLETED

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

Details

Lead sponsor	NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)
Phase	Phase 1
Status	COMPLETED
Enrolment	56
Start date	2005-02
Completion	2005-12

Conditions

• Onychomycosis/Onycholysis and Tinea Pedis

Interventions

• Placebo
• Terbinafine Hydrochloride
• Terbinafine Hydrochloride
• Terbinafine

Primary outcomes

• 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) — 28 Days

Countries

United States