Onychomycosis of ToenailPhase 1NCT05110638
Safety and Tolerability Study of SKX-16 in Subjects With Moderate to Severe Distal Subungual Onychomycosis
A Phase 1 study testing SKX-16 (Luliconazole 10% Solution) in people with Onychomycosis of Toenail, run by SATO Pharmaceutical Co., Ltd. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Onychomycosis of Toenail
- What is being tested?
- SKX-16 (Luliconazole 10% Solution)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2021to 6 Jun 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Subjects must have ten toes.
- 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.
- In addition to both great toenails, subjects must have at least four additional toenails with clinical diagnosis of distal subungual onychomycosis.
- 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.
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- Subjects must have normal renal function as measured by serum creatinine < ULN.
- Subjects must have normal hepatic function as measured by aspartate aminotransferase (AST/SGOT), alanine aminotransferase (ALT/SGPT), and total bilirubin < ULN.
- 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.
- 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.
- Subject must be able to communicate, be able to understand the study procedures, and be willing to comply with the study requirements.
Who cannot join
- 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.
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- 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).
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label Study Evaluating the Pharmacokinetics, Absorption, Safety and Tolerability With Maximal Use of SKX-16 (Luliconazole 10% Solution) in Subjects With Moderate to Severe Distal Subungual Onychomycosis
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.
Read the detailed 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.
- Conditions
- Onychomycosis of Toenail
- Being tested
- SKX-16 (Luliconazole 10% Solution)
- Keywords
- Onychomycosis
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| SKX-16 (Luliconazole 10% Solution) | Experimental | Not described Receives: Drug: SKX-16 (Luliconazole 10% Solution) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 36 days
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.
Measured: 36 days
PK parameters for the systemic absorption of luliconazole - kel
The pharmacokinetics parameter kel (elimination rate constant) will be measured for systemic absorption of luliconazole.
Measured: 36 days
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.
Measured: 36 days
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.
Measured: 36 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start22 Sep 2021
- Primary completion30 May 2022
- Study completion6 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Onychomycosis of ToenailStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- SATO Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brent Clary, CCRC, Study chair, Clinical Research Coordinator J&S Studies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05110638
- Sponsor's protocol ID
- SKX16A01
- Status last verified
- Aug 2026
- First submitted
- 25 Jul 2021
- Last updated
- 21 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study Evaluating the Pharmacokinetics, Absorption, Safety and Tolerability With Maximal Use of SKX-16 (Luliconazole 10% Solution) in Subjects With Moderate to Severe Distal Subungual Onychomycosis
- ClinicalTrials.gov ID
- NCT05110638
- Acronym / sponsor ID
- SKX16A01
- Conditions
- Onychomycosis of Toenail
- Keywords
- Onychomycosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- SATO Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Sep 2021 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 6 Jun 2022 (actual)
- First posted
- 8 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SKX-16 (Luliconazole 10% Solution) | Experimental | Drug: SKX-16 (Luliconazole 10% Solution) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
- Subjects must have ten toes.
- 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.
- In addition to both great toenails, subjects must have at least four additional toenails with clinical diagnosis of distal subungual onychomycosis.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | SKX-16 (Luliconazole 10% Solution) |
Primary outcome
PK parameters for the systemic absorption of luliconazole - AUC0-24h
Time frame: 36 days
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
PK parameters for the systemic absorption of luliconazole - AUC0-∞
Time frame: 36 days
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.
PK parameters for the systemic absorption of luliconazole - Cmax
Time frame: 36 days
The pharmacokinetics parameter Cmax (the maximum observed concentration over the 0-24 hour interval) will be measured for systemic absorption of luliconazole.
PK parameters for the systemic absorption of luliconazole - Tmax
Time frame: 36 days
The pharmacokinetics parameter Tmax (the time to maximum observed concentration over the 0-24 hour interval) will be measured for systemic absorption of luliconazole.
PK parameters for the systemic absorption of luliconazole - t1/2
Time frame: 36 days
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.
PK parameters for the systemic absorption of luliconazole - kel
Time frame: 36 days
The pharmacokinetics parameter kel (elimination rate constant) will be measured for systemic absorption of luliconazole.
Safety Assessment - Local Application Site Tolerability Assessment (LASTA)
Time frame: 36 days
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.
Safety Assessment - Adverse Events
Time frame: 36 days
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brent Clary, CCRC study chair
Clinical Research Coordinator J&S Studies, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SKX-16 (Luliconazole 10% Solution) in people with Onychomycosis of Toenail, run by SATO Pharmaceutical Co., Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PK parameters for the systemic absorption of luliconazole - AUC0-24h (time frame: 36 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.