Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05110638
Other study ID # SKX16A01
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date September 13, 2021
Est. completion date February 22, 2023

Study information

Verified date June 2022
Source SATO Pharmaceutical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is being conducted to determine the pharmacokinetics, systemic exposure, safety and tolerability after daily topical application of SKX-16 (Luliconazole 10% Solution) for duration of 29 days in a maximal use setting in adults with moderate to severe distal subungual onychomycosis of the toenails.


Description:

Subjects in this open-label study will receive once daily, topical applications of SKX-16 (Luliconazole 10% Solution) in the clinic for 29 days. Subjects will be followed for seven days after the last application (Day 29). Subjects will be admitted into the study after written informed consent has been obtained and all inclusion/exclusion criteria have been met.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 20
Est. completion date February 22, 2023
Est. primary completion date December 10, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: 1. Subjects demonstrate ability and willingness to sign a written informed consent. 2. Subjects of either gender, any race and between the ages of 18 and 65 inclusive. 3. Subjects must have ten toes. 4. Subjects with a clinical diagnosis of distal subungual onychomycosis involving both great toenails and = 50% of at least one of the great toenails, as determined by visual inspection after the nail is trimmed. 5. In addition to both great toenails, subjects must have at least four additional toenails with clinical diagnosis of distal subungual onychomycosis. 6. Subjects must have a mycological diagnosis of distal subungual onychomycosis: fungal hyphae on KOH wet mount and positive fungal culture for dermatophyte (microbial infection with fungus belonging to the genus Trichophyton, Microsporum, Epidermophyton) from at least one great toenail. 7. Subjects must have normal renal function as measured by serum creatinine < ULN. 8. Subjects must have normal hepatic function as measured by aspartate aminotransferase (AST/SGOT), alanine aminotransferase (ALT/SGPT), and total bilirubin < ULN. 9. Females of child-bearing potential (FOCBP) must have a negative urine pregnancy test and must agree to use a highly effective form of contraception or abstinence and be willing to remain on that same method of birth control throughout the study. 10. Subjects must be free of any disease that in the Investigator's opinion might interfere with the study evaluations or jeopardize the subject's safety. 11. Subject must be able to communicate, be able to understand the study procedures, and be willing to comply with the study requirements. Exclusion Criteria: 1. Subjects with a history of intolerance or hypersensitivity to imidazole compounds or the inactive components of the solution. 2. Subjects with an abnormal ECG morphology and/or a QTcF interval > 450 ms for males and >470 ms for females. 3. Subjects with any history of cardiac disease or cardiac rhythm abnormalities. 4. Subjects with symptomatic tinea pedis at baseline. 5. Subjects unwilling to refrain from the use of nail cosmetics including nail lacquers from the Screening visit until the end of the study. 6. Female subjects who are pregnant and/or nursing or planning a pregnancy during the course of the trial. 7. Concomitant use of any drugs that are CYP3A and CYP2C19 substrates with QT interval prolongation potential. 8. 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. 9. 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. 10. 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 11. 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. 12. 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. 13. Subjects with anatomic abnormalities of the toe(s) and/or toenails, e.g., genetic nail disorders, trauma to the toenail(s). 14. Subjects with a recent history of or currently known to abuse drugs or alcohol. 15. 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). 16. Subjects who are currently participating in another investigational medication or device study or have participated in a clinical trial within 30 days or 5 half-lives of the test medication (whichever is longer) prior to Baseline visit (Day 1) of this study.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
SKX-16 (Luliconazole 10% Solution)
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.

Locations

Country Name City State
United States J&S Studies, Inc. College Station Texas

Sponsors (1)

Lead Sponsor Collaborator
SATO Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary PK parameters for the systemic absorption of luliconazole - AUC0-8 The pharmacokinetics parameter AUC0-8 (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
Primary 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
Primary 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
Primary PK parameters for the systemic absorption of luliconazole - t1/2 The pharmacokinetics parameter t1/2 (the time to maximum observed concentration over the 0-24 hour interval) will be measured for systemic absorption of luliconazole. 36 days
Primary PK parameters for the systemic absorption of luliconazole - kel The pharmacokinetics parameter kel (elimination rate constant) will be measured for systemic absorption of luliconazole. 36 days
Primary Safety Assessment - Local Application Site Tolerability Assessment (LASTA) Evaluation of burning/stinging, pruritus, erythema, and erosion assessed through to Day 29/ET on a scale of 0 to 3 where 0 indicates none and 3 indicates severe. 36 days
Primary Safety Assessment - Adverse Events Subjects will be asked about AEs at each visit; descriptions of AEs will include at minimum: date of onset, date ended, location (whether or not AE is in the treatment area), severity, seriousness, relationship to study drug, and outcome. 36 days
See also
  Status Clinical Trial Phase
Completed NCT03110029 - Evaluating the Efficacy and Compatibility of Efinaconazole 10% Solution (Jublia) for the Treatment of Toenail Onychomycosis in Patients Wearing Toenail Polish Compared to Those Without Polish Phase 4
Completed NCT05260450 - Laser Treatment of Toenail Onychomycosis With a 1064 nm Nd:YAG-laser N/A
Completed NCT03382717 - Efficacy and Safety of a Medical Device for the Treatment of Toenail Onychomycosis N/A
Not yet recruiting NCT06417983 - Topical Application of Essential Oils to Treat Onchomycosis
Withdrawn NCT03094468 - Study to Evaluate the Efficacy and Safety of P-3058 Nail Solution in the Treatment of Onychomycosis Phase 3
Recruiting NCT05674747 - Pilot Study of Swift Microwave Device for Onychomycosis Phase 1/Phase 2
Recruiting NCT06006455 - Effect of the Erchonia® LunulaLaserâ„¢ for the Treatment of Toenail Onychomycosis N/A
Not yet recruiting NCT03098342 - Comparison of Efficacy and Safety Between Methylene Blue-mediated Photodynamic Therapy and 5% Amorolfine Nail Lacquer for Toenail Onychomycosis Treatment N/A
Completed NCT03216200 - Early Feasibility Study to Evaluate the Efficacy of the RenewalNailâ„¢ Plasma Treatment System in Patients With Onychomycosis (Fungal Nail) N/A
Recruiting NCT04042857 - Safety and Efficacy of Next Science Gel on Toenail Fungus N/A
Active, not recruiting NCT05135910 - To Evaluate Hallux Terbinafine Subungual Gel (HSG) in the Treatment of Onychomycosis Phase 2
Active, not recruiting NCT05139888 - Light Therapy for Onychomycosis Study N/A
Completed NCT04961684 - Clinical Evaluation of Efficacy and Safety of a Medical Device for the Treatment of Toenail Onychomycosis N/A
Completed NCT03141840 - Clinical Trial of Topical ABL01 Treatment of Onychomycosis N/A
Recruiting NCT04084782 - An Internet Mediated Research Study to Assess the Quality of Life of Consumers With Self-reported Fungal Nail Infection (Onychomycosis) During Treatment With Scholl Fungal Nail.
Withdrawn NCT03066336 - A Study to See if Low Level Laser Light Can Help to Treat Toenail Fungus N/A