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

Phase 1

Completed

• Conditions: Onychomycosis
• Interventions: Drug: Luliconazole Solution, 10%

• Registration Number: NCT01044381
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-01-04
• Study First Submitted QC: 2010-01-05
• Study First Posted: 2010-01-07
• Study Start: 2010-12
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Disposition First Submitted: 2011-06-13
• Disposition First Submitted QC: 2011-07-19
• Disposition First Posted: 2011-07-22
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-13
• Last Update Posted: 2014-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Luliconazole Solution, 10%	Luliconazole Solution, 10%	-

Primary Outcome Measures

Name	Time	Method
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.	March 2011

Secondary Outcome Measures

Name	Time	Method
Evaluation of linear toenail growth.	March 2011

Trial Locations

Locations (1)

J&S Studies; 🇺🇸 College Station, Texas, United States