Open-Label Pharmacokinetics (PK)/Safety Study of Luliconazole Solution, 10% in Distal Subungual Onychomycosis
Primary Purpose
Onychomycosis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Luliconazole Solution, 10%
Sponsored by
About this trial
This is an interventional treatment trial for Onychomycosis focused on measuring Toenail, Fungal Infections, DSO
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
Sites / Locations
- J&S Studies
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Luliconazole Solution, 10%
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Evaluation of linear toenail growth.
Full Information
NCT ID
NCT01044381
First Posted
January 4, 2010
Last Updated
November 13, 2014
Sponsor
Topica Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01044381
Brief Title
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
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Topica Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis
Keywords
Toenail, Fungal Infections, DSO
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Luliconazole Solution, 10%
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Luliconazole Solution, 10%
Intervention Description
28 days of daily application
Primary Outcome Measure Information:
Title
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.
Time Frame
March 2011
Secondary Outcome Measure Information:
Title
Evaluation of linear toenail growth.
Time Frame
March 2011
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terry M Jones, M.D.
Organizational Affiliation
J&S Studies
Official's Role
Principal Investigator
Facility Information:
Facility Name
J&S Studies
City
College Station
State/Province
Texas
ZIP/Postal Code
77840
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Open-Label Pharmacokinetics (PK)/Safety Study of Luliconazole Solution, 10% in Distal Subungual Onychomycosis
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