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

5. november 2026 opdateret af: SATO Pharmaceutical Co., Ltd.

A Phase 2, Multicenter, Randomized, Double-Blind Study Evaluating the Safety and Efficacy of SKX-16 (Luliconazole 10% Solution) in Participants With Mild to Moderate Distal Subungual Onychomycosis of the Toenails

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

204

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Mehria Afzal Patient Recruitment and Site Engagement Specialist
  • Telefonnummer: 326 866-575-3111
  • E-mail: mafzal@inderocro.com

Studiesteder

  • Forenede Stater
    • California
      • Los Angeles, California, Forenede Stater, 900045
        • SKX16B01 Clinical Study - Site 105
        • Kontakt:
          • Mehria Afzal Pts Recruitment and Site Engagement Specialist, Indero (CRO)
          • Telefonnummer: 866-575-3111
          • E-mail: mafzal@inderocro.com
      • San Francisco, California, Forenede Stater, 94115
        • SKX16B01 Clinical Study - Site 101
        • Kontakt:
          • Mehria Afzal Pts Recruitment and Site Engagement Specialist, Indero (CRO)
          • Telefonnummer: 866-575-3111
          • E-mail: mafzal@inderocro.com
    • Florida
      • Miami, Florida, Forenede Stater, 11760
        • SKX16B01 Clinical Study - Site 104
        • Kontakt:
          • Mehria Afzal Pts Recruitment and Site Engagement Specialist, Indero (CRO)
          • Telefonnummer: 866-575-3111
          • E-mail: mafzal@inderocro.com
      • Miami, Florida, Forenede Stater, 33126
        • SKX16B01 Clinical Study - Site 109
        • Kontakt:
          • Mehria Afzal Pts Recruitment and Site Engagement Specialist, Indero (CRO)
          • Telefonnummer: 866-575-3111
          • E-mail: mafzal@inderocro.com
    • Texas
      • College Station, Texas, Forenede Stater, 77845
        • SKX16B01 Clinical Study - Site 111
        • Kontakt:
          • Mehria Afzal Pts Recruitment and Site Engagement Specialist, Indero (CRO)
          • Telefonnummer: 866-575-3111
          • E-mail: mafzal@inderocro.com
      • Houston, Texas, Forenede Stater, 77027
        • SKX16B01 Clinical Study - Site 119
        • Kontakt:
          • Mehria Afzal Pts Recruitment and Site Engagement Specialist, Indero (CRO)
          • Telefonnummer: 866-575-3111
          • E-mail: mafzal@inderocro.com

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Active Arm

SKX-16 (Luliconazole 10% Solution)
Medicin: SKX-16 (Luliconazole 10% Solution)

Applied topically once daily for 52 weeks to all affected toenails identified by the investigator, followed by a Week 56 follow-up visit.
Placebo komparator: Vehicle Arm

Vehicle solution that does not contain active ingredients.
Medicin: Vehicle solution

Applied topically once daily for 52 weeks to all affected toenails identified by the investigator, followed by a Week 56 follow-up visit, under the same conditions as the active arm.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Complete Cure at Week 56
Tidsramme: 56 weeks

Proportion of participants who achieve Complete Cure of the target toenail at Week 56, as defined by clinical cure (completely clear target great toenail as assessed by the investigator) and mycological cure (negative KOH microscopy and negative culture)
56 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mycological Cure at Week 56
Tidsramme: 56 weeks

Proportion of participants with mycological cure (negative KOH microscopy and negative culture) of the target toenail at Week 56
56 weeks
Clinical Cure at Week 56
Tidsramme: 56 weeks

Proportion of participants with clinical cure (completely clear target great toenail as assessed by the investigator) at Week 56
56 weeks
≤5% Affected Nail Area + Mycological Cure at Week 56
Tidsramme: 56 weeks

Proportion of participants with ≤ 5% of affected target toenail area and mycological cure of the target toenail at Week 56
56 weeks
<10% Affected Nail Area + Mycological Cure at Week 56
Tidsramme: 56 weeks

Proportion of participants with < 10% of affected target toenail area and mycological cure of the target toenail at Week 56
56 weeks
Percent Change in Affected Nail Area
Tidsramme: Baseline and Week 56

Percent change from baseline in percentage of affected target toenail area at Week 56
Baseline and Week 56
Clear Nail Growth at Week 56
Tidsramme: 56 weeks

Clear nail growth of the target toenail at Week 56
56 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

SATO Pharmaceutical Co., Ltd.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

24. november 2026

Primær færdiggørelse (Anslået)

23. september 2028

Studieafslutning (Anslået)

21. oktober 2028

Datoer for studieregistrering

Først indsendt

15. oktober 2026

Først indsendt, der opfyldte QC-kriterier

5. november 2026

Først opslået (Faktiske)

10. november 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SKX16B01

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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