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

Topica Pharmaceuticals

Status and phase

Completed

Phase 2

Phase 1

Conditions

Onychomycosis

Treatments

Drug: Luliconazole Solution, 10%

Study type

Interventional

Funder types

Industry

Identifiers

NCT01044381

TP-0901-S

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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