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

November 13, 2014 updated by: Topica Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • College Station, Texas, United States, 77840
        • J&S Studies

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-65 years
  • Distal Subungual Onychomycosis(DSO)on both great toenails with >=50%involvement of at least 1 great toenail
  • At least 4 additional toenails with DSO
  • Positive KOH and culture
  • Normal renal and hepatic function

Exclusion Criteria:

  • Subjects with hypersensitivity to imidazole compounds or any other ingredient
  • Subjects unwilling to refrain from use of nail cosmetics until end of study
  • Subjects with symptomatic tinea pedis
  • Subjects with any history of cardiac disease of cardiac rhythm abnormalities
  • Female subjects who are pregnant, nursing, or planning a pregnancy
  • Subjects who have not undergone the specified washout period(s) for the following or requiring the concurrent use of: topical antifungal within 4 weeks; topical anti-inflammatory, corticosteroids, topical immunomodulators within 2 weeks; systemic corticosteroids within 2 weeks; systemic immunomodulators within 4 weeks.
  • Subjects receiving systemic antifungals for treatment of onychomycosis or any systemic antifungal with known activity against dermatophytes within the previous 12 weeks or 5 half-lives of the drug, whichever is longer
  • Subjects receiving any other treatment/therapy for the onychomycosis not previously mentioned (e.g., laser treatment) within 4 weeks
  • Subjects with a history of significant internal disease or with a life threatening condition within the last 6 months
  • Subjects with anatomic abnormalities of the toe(s) and or toenails
  • Subject who have donated or lost a large volume of blood (~500 mL or more, during the previous 6 weeks
  • Subjects with a recent history of or currently known to abuse drugs or alcohol
  • Subjects currently participating in another investigational medication or device study or have participated in a clinical trial within 30 days or five half-lives of the test medication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Luliconazole Solution, 10%
Drug: Luliconazole Solution, 10%
28 days of daily application

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PK parameters (AUC, Cmax, Tmax, t1/2) will be measured at days 1 (Baseline), 9, 15 and 29. Safety assessments include monitoring of adverse events, local site tolerability, ECG monitoring, and changes in laboratory values and vital signs.
Time Frame: March 2011
March 2011

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluation of linear toenail growth.
Time Frame: March 2011
March 2011

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Topica Pharmaceuticals

Investigators

  • Principal Investigator: Terry M Jones, M.D., J&S Studies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

January 4, 2010

First Submitted That Met QC Criteria

January 5, 2010

First Posted (Estimate)

January 7, 2010

Study Record Updates

Last Update Posted (Estimate)

November 26, 2014

Last Update Submitted That Met QC Criteria

November 13, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TP-0901-S

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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