Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

5. november 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

204

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

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

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 70 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Active Arm

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

SATO Pharmaceutical Co., Ltd.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

24. november 2026

Primær fullføring (Antatt)

23. september 2028

Studiet fullført (Antatt)

21. oktober 2028

Datoer for studieregistrering

Først innsendt

15. oktober 2026

Først innsendt som oppfylte QC-kriteriene

5. november 2026

Først lagt ut (Faktiske)

10. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • SKX16B01

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere