Trials Sponsors Conditions Drugs Pricing

Conditions

Onychomycosis of Toenail

Keywords

Onychomycosis

Outcome Measures

Primary Outcomes (8)

PK parameters for the systemic absorption of luliconazole - AUC0-24h
The pharmacokinetics parameter AUC0-24h (the area under the concentration versus time curve measured to the 24 hour time point) will be measured for systemic absorption of luliconazole
36 days
PK parameters for the systemic absorption of luliconazole - AUC0-∞
The pharmacokinetics parameter AUC0-∞ (the area under the concentration versus time curve measured to the end of the sampling period) will be measured for systemic absorption of luliconazole.
36 days
PK parameters for the systemic absorption of luliconazole - Cmax
The pharmacokinetics parameter Cmax (the maximum observed concentration over the 0-24 hour interval) will be measured for systemic absorption of luliconazole.
36 days
PK parameters for the systemic absorption of luliconazole - Tmax
The pharmacokinetics parameter Tmax (the time to maximum observed concentration over the 0-24 hour interval) will be measured for systemic absorption of luliconazole.
36 days
PK parameters for the systemic absorption of luliconazole - t1/2

Study Arms (1)

SKX-16 (Luliconazole 10% Solution)

EXPERIMENTAL

Drug: SKX-16 (Luliconazole 10% Solution)

Interventions

SKX-16 (Luliconazole 10% Solution)Drug

SKX-16 (Luliconazole 10% Solution) will be applied to each toenail and periungual areas once daily for 29 days such that there is sufficient quantity of solution to treat all toenails. All ten toes will be treated regardless of whether affected. The applications will occur in the clinic and be applied by study personnel. The nails will remain exposed until the applied solution dries.

SKX-16 (Luliconazole 10% Solution)

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Subjects demonstrate ability and willingness to sign a written informed consent.
Subjects of either gender, any race and between the ages of 18 and 65 inclusive.

Sponsors & Collaborators

SATO Pharmaceutical Co., Ltd.
Industrylead

Study Sites (1)

J&S Studies, Inc.

College Station, Texas, 77845, United States

MeSH Terms

Conditions

Onychomycosis

Interventions

luliconazoleSolutions

Condition Hierarchy (Ancestors)

TineaDermatomycosesMycosesBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousNail DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Officials

Brent Clary, CCRC
Clinical Research Coordinator J&S Studies, Inc.
STUDY CHAIR

Enrollment

19 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 25, 2021

First Posted

November 8, 2021

Study Start

September 22, 2021

Actual (reported)

You may not qualify if:

Subjects with a history of intolerance or hypersensitivity to imidazole compounds or the inactive components of the solution.
Subjects with an abnormal ECG morphology and/or a QTcF interval \> 450 ms for males and \>470 ms for females.
Subjects with any history of cardiac disease or cardiac rhythm abnormalities.
Subjects with symptomatic tinea pedis at baseline.
Subjects unwilling to refrain from the use of nail cosmetics including nail lacquers from the Screening visit until the end of the study.
Female subjects who are pregnant and/or nursing or planning a pregnancy during the course of the trial.
Concomitant use of any drugs that are CYP3A and CYP2C19 substrates with QT interval prolongation potential.
Subjects who have not undergone the specified washout period(s) prior to Baseline visit (Day 1) for the following topical preparations, or subjects requiring the concurrent use of any of the following topical medications: Topical antifungal applied to the feet, drugs that contain luliconazole, anti-inflammatories, corticosteroids or topical immunomodulators.
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 who have not undergone the specified washout period(s) prior to Baseline (Day 1) for the following systemic medications, or subjects requiring the concurrent use of any of the following systemic medications: Corticosteroids (including intramuscular injections), systemic immunomodulators and drugs that are CYP3A and CYP2C19 substrates
Subjects receiving any other treatment/therapy for their onychomycosis not previously mentioned (e.g., laser treatment) who have not undergone a washout period of 4 weeks.
Subjects with a history of significant internal disease (including diabetes that is uncontrolled), history or signs of peripheral circulatory insufficiency and/or diabetic neuropathy, recurrent cellulitis or with a life-threatening condition (e.g., autoimmune deficiency syndrome, cancer, unstable angina, or myocardial infarction) as assessed by the Investigator within the last 6 months.
Subjects with anatomic abnormalities of the toe(s) and/or toenails, e.g., genetic nail disorders, trauma to the toenail(s).
Subjects with a recent history of or currently known to abuse drugs or alcohol.
Subjects who have donated or lost a large volume of blood (\~500 mL or more), during the 6-week period preceding Baseline visit (Day 1).
+1 more criteria

Safety and Tolerability Study of SKX-16 in Subjects With Moderate to Severe Distal Subungual Onychomycosis

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (8)

Study Arms (1)

SKX-16 (Luliconazole 10% Solution)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (8)

Study Arms (1)

SKX-16 (Luliconazole 10% Solution)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations