Clinical trial NCT01044381: Open-Label Pharmacokinetics (PK)/Safety Study of Luliconazole Solution, 10% in Distal Subungual Onychomycosis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Onychomycosis
Keywords: Toenail
Fungal Infections
DSO
Lead sponsor: Topica Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2010-01-07
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: March 2011
Secondary outcomes:
measure: Evaluation of linear toenail growth.
timeFrame: March 2011
Other outcomes:
Locations:
city: College Station
country: United States
facility: J&S Studies
state: Texas
Study officials:
affiliation: J&S Studies
name: Terry M Jones, M.D.
role: PRINCIPAL_INVESTIGATOR
References: