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

NCT01044381 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2014-11-26

No results posted yet for this study

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

DRUG

Luliconazole Solution, 10%

28 days of daily application

Sponsors & Collaborators

  • Topica Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Terry M Jones, M.D. · J&S Studies

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01044381 on ClinicalTrials.gov