Open-Label Pharmacokinetics (PK)/Safety Study of Lulicona... | NCT01044381

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

NCT01044381

Sponsor

Topica Pharmaceuticals

Status

Completed

Last Update Posted

Nov 26, 2014Estimated

Enrollment

24Actual

Phase

Phase 1Phase 2

Conditions

Onychomycosis

Interventions

Luliconazole Solution, 10%

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2010

Primary Completion Date

May 2011Actual

Completion Date

May 2011Actual

First Submitted Date

Jan 4, 2010

First Submission Date that Met QC Criteria

Jan 5, 2010

First Posted Date

Jan 7, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Jun 13, 2011

Certification/Extension First Submitted that Passed QC Review

Jul 19, 2011

Certification/Extension First Posted Date

Jul 22, 2011Estimated

Last Update Submitted Date

Nov 13, 2014

Last Update Posted Date

Nov 26, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Label	Type	Description	Intervention Names
Luliconazole Solution, 10%	Experimental		Drug: Luliconazole Solution, 10%

Name	Type	Description	Arm Group Labels	Other Names
Luliconazole Solution, 10%	Drug	28 days of daily application	Luliconazole Solution, 10%

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
Evaluation of linear toenail growth.		March 2011

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D014009	Onychomycosis
D009181	Mycoses

ID	Term
D014005	Tinea
D003881	Dermatomycoses
D001423	Bacterial Infections and Mycoses
D007239	Infections