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

NCT ID: NCT01044381

Last Updated: 2014-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-05-31

Brief Summary

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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

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Conditions

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Onychomycosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Luliconazole Solution, 10%

Group Type EXPERIMENTAL

Luliconazole Solution, 10%

Intervention Type DRUG

28 days of daily application

Interventions

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Luliconazole Solution, 10%

28 days of daily application

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Topica Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Terry M Jones, M.D.

Role: PRINCIPAL_INVESTIGATOR

J&S Studies

Locations

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J&S Studies

College Station, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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TP-0901-S

Identifier Type: -

Identifier Source: org_study_id