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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Topica Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01044381
First received: January 4, 2010
Last updated: October 28, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Onychomycosis
Drug: Luliconazole Solution, 10%
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Topica Pharmaceuticals:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of linear toenail growth. [ Time Frame: March 2011 ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: December 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Luliconazole Solution, 10% Drug: Luliconazole Solution, 10%
28 days of daily application

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01044381

Locations
United States, Texas
J&S Studies
College Station, Texas, United States, 77840
Sponsors and Collaborators
Topica Pharmaceuticals
Investigators
Principal Investigator: Terry M Jones, M.D. J&S Studies
  More Information

No publications provided

Responsible Party: Topica Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01044381     History of Changes
Other Study ID Numbers: TP-0901-S
Study First Received: January 4, 2010
Last Updated: October 28, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Topica Pharmaceuticals:
Toenail
Fungal Infections
DSO

Additional relevant MeSH terms:
Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Nail Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 16, 2014