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

5 novembre 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

204

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Mehria Afzal Patient Recruitment and Site Engagement Specialist
  • Numero di telefono: 326 866-575-3111
  • Email: mafzal@inderocro.com

Luoghi di studio

  • Stati Uniti
    • California
      • Los Angeles, California, Stati Uniti, 900045
        • SKX16B01 Clinical Study - Site 105
        • Contatto:
          • Mehria Afzal Pts Recruitment and Site Engagement Specialist, Indero (CRO)
          • Numero di telefono: 866-575-3111
          • Email: mafzal@inderocro.com
      • San Francisco, California, Stati Uniti, 94115
        • SKX16B01 Clinical Study - Site 101
        • Contatto:
          • Mehria Afzal Pts Recruitment and Site Engagement Specialist, Indero (CRO)
          • Numero di telefono: 866-575-3111
          • Email: mafzal@inderocro.com
    • Florida
      • Miami, Florida, Stati Uniti, 11760
        • SKX16B01 Clinical Study - Site 104
        • Contatto:
          • Mehria Afzal Pts Recruitment and Site Engagement Specialist, Indero (CRO)
          • Numero di telefono: 866-575-3111
          • Email: mafzal@inderocro.com
      • Miami, Florida, Stati Uniti, 33126
        • SKX16B01 Clinical Study - Site 109
        • Contatto:
          • Mehria Afzal Pts Recruitment and Site Engagement Specialist, Indero (CRO)
          • Numero di telefono: 866-575-3111
          • Email: mafzal@inderocro.com
    • Texas
      • College Station, Texas, Stati Uniti, 77845
        • SKX16B01 Clinical Study - Site 111
        • Contatto:
          • Mehria Afzal Pts Recruitment and Site Engagement Specialist, Indero (CRO)
          • Numero di telefono: 866-575-3111
          • Email: mafzal@inderocro.com
      • Houston, Texas, Stati Uniti, 77027
        • SKX16B01 Clinical Study - Site 119
        • Contatto:
          • Mehria Afzal Pts Recruitment and Site Engagement Specialist, Indero (CRO)
          • Numero di telefono: 866-575-3111
          • Email: mafzal@inderocro.com

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 70 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Active Arm

SKX-16 (Luliconazole 10% Solution)
Droga: 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.
Comparatore placebo: Vehicle Arm

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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Complete Cure at Week 56
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mycological Cure at Week 56
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 56 weeks

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

SATO Pharmaceutical Co., Ltd.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

24 novembre 2026

Completamento primario (Stimato)

23 settembre 2028

Completamento dello studio (Stimato)

21 ottobre 2028

Date di iscrizione allo studio

Primo inviato

15 ottobre 2026

Primo inviato che soddisfa i criteri di controllo qualità

5 novembre 2026

Primo Inserito (Effettivo)

10 novembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • SKX16B01

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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