NCT01044381

Open-Label Pharmacokinetics (PK)/Safety Study of Luliconazole Solution, 10% in Distal Subungual Onychomycosis

A Phase 1/2a, Open-Label Study Evaluating the Pharmacokinetics, Safety and Tolerability of Luliconazole Solution, 10% in Subjects With Moderate to Severe Distal Subungual Onychomycosis

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Topica Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To determine the safety, tolerability, systemic exposure and pharmacokinetics of luliconazole after repeat daily topical application of Luliconazole Solution, 10% in a maximal use setting in adults with distal subungual onychomycosis of the toenails.

Conditions

• Onychomycosis

Interventions

Type	Name	Description
DRUG	Luliconazole Solution, 10%	28 days of daily application

Timeline

• Start date: 2010-12-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2010-01-07
• Last updated: 2014-11-26

Locations

1 site across 1 country: United States