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

5 november 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

204

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

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

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 70 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Active Arm

SKX-16 (Luliconazole 10% Solution)
Geneesmiddel: 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-vergelijker: Vehicle Arm

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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Complete Cure at Week 56
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Mycological Cure at Week 56
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 56 weeks

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

SATO Pharmaceutical Co., Ltd.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

24 november 2026

Primaire voltooiing (Geschat)

23 september 2028

Studie voltooiing (Geschat)

21 oktober 2028

Studieregistratiedata

Eerst ingediend

15 oktober 2026

Eerst ingediend dat voldeed aan de QC-criteria

5 november 2026

Eerst geplaatst (Werkelijk)

10 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

10 november 2026

Laatste update ingediend die voldeed aan QC-criteria

5 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • SKX16B01

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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