Safety and Efficacy Study of SKX-16 in Participants With Mild to Moderate Distal Subungual Onychomycosis

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Phase 2

Age range

18 years - 70 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

204 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

This is a parallel group, double blind, vehicle-controlled study in which SKX-16 or vehicle (2:1 randomization) is applied once a day for 52 weeks to all affected toenails to participants with mild to moderate distal subungual onychomycosis (DSO) of the toenails involving between 20 to 50% of at least one great toenail at Screening.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

• Participant is willing to participate and is capable of giving informed consent. Note: Consent must be obtained prior to any study-related procedures.
• Male or female participant of any race aged 18 to 70 years, inclusive, at the time of consent.
• Participants with a clinical diagnosis of DSO, involving 20%-50% of at least one of the great toenails at screening.
• Participants must have no more than 5 toes with suspected presence of onychomycosis (ie, no more than a total of 5 infected toenails, including ≤3 non-great toenails and up to 2 great toenails) at screening.
• Participant's target great toenail must have no involvement of the lunula (matrix) and have ≥ 4 mm of clear (unaffected) nail distal from the proximal nail fold at screening.
• Clinical judgment supports that the historical growth rate of the target great toenail will permit monthly toenail clipping during the study.
• Participant must be willing and able to comply with all study procedures and must be available for the duration of the study.

Exclusion Criteria:

• Participant is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
• Participant has a history or presence of a skin condition on the feet that, in the opinion of the investigator, would interfere with the study assessments.
• Participant is known to have immune deficiency or is immunocompromised.
• Participant has continuous onychomycosis of the toenail(s) for ≥ 5 consecutive years immediately prior to Screening visit without any intervening period of complete resolution (information obtained from medical chart or participant's physician, or directly from the participant).
• Participant has fingernails with suspected presence of onychomycosis.
• Participant has disease involvement confined exclusively to the lateral edge of the target great toenail.
• Participant has "spike" of onychomycosis extending to eponychium of the target great toenail.
• Participant had a major surgery within 8 weeks prior to Day 1 or has a major surgery planned during the study.
• Participant has any clinically significant medical condition or physical/laboratory/vital signs abnormality that would, in the opinion of the investigator, put the participant at undue risk or interfere with interpretation of study results.
• Participant has a known history of chronic infectious disease (eg, hepatitis B, hepatitis C, or human immunodeficiency virus \[HIV\]).
• Participant has a known history of diabetes and an HbA1C ≥ 8% at screening.
• Participant has reported to have previously failed a standard course of oral antifungal treatment for onychomycosis.
• Participant received prior laser treatment, photodynamic therapy, or chemical or surgical treatment for onychomycosis within the last 12 months prior to Day 1.
• Participant has used any prescription or OTC topical antifungal therapy for the toenails within 4 weeks prior to Day 1.
• Participant has used systemic antifungal therapies within 6 months prior to Day 1.
• Participant has used any topical medicated treatment applied to the feet within 2 weeks prior to Day 1, including but not limited to, anti-inflammatory medications, topical corticosteroids, or topical immunomodulators.
• Participant is currently receiving an investigational product or device for any indication, or has received one within 4 weeks prior to Day 1 (excluding investigational products in trials pertaining to Exclusion Criterion #32).
• Participant is unwilling to refrain from the use of other prescription or OTC onychomycosis treatments, nail cosmetics on their toenails (including nail lacquers), or pedicures from the screening visit until the end of the study.
• Participant has a known or suspected hypersensitivity or allergy to luliconazole or imidazole compounds or the excipients of the formulation.
• Participant has a known history of clinically significant drug or alcohol abuse in the last year prior to Day 1.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

Quadruple masked

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (6)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

6 locations

Study team and timeline

Lead sponsor

SATO Pharmaceutical Co., Ltd.

Study start

Nov 24, 2026 Estimated

Primary completion

Sep 23, 2028 Estimated

Study completion

Oct 21, 2028 Estimated

First posted

Nov 10, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts