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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01044381
Recruitment Status : Completed
First Posted : January 7, 2010
Last Update Posted : November 26, 2014
Information provided by (Responsible Party):
Topica Pharmaceuticals

Brief 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.

Condition or disease Intervention/treatment Phase
Onychomycosis Drug: Luliconazole Solution, 10% Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2010
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Evaluation of linear toenail growth. [ Time Frame: March 2011 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01044381

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

Responsible Party: Topica Pharmaceuticals Identifier: NCT01044381     History of Changes
Other Study ID Numbers: TP-0901-S
First Posted: January 7, 2010    Key Record Dates
Last Update Posted: November 26, 2014
Last Verified: November 2014

Keywords provided by Topica Pharmaceuticals:
Fungal Infections

Additional relevant MeSH terms:
Skin Diseases, Infectious
Nail Diseases
Skin Diseases
Pharmaceutical Solutions