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

5 november 2026 uppdaterad 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

204

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

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

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 70 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Active Arm

SKX-16 (Luliconazole 10% Solution)
Läkemedel: 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-jämförare: Vehicle Arm

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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Complete Cure at Week 56
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Mycological Cure at Week 56
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 56 weeks

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

SATO Pharmaceutical Co., Ltd.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

24 november 2026

Primärt slutförande (Beräknad)

23 september 2028

Avslutad studie (Beräknad)

21 oktober 2028

Studieregistreringsdatum

Först inskickad

15 oktober 2026

Först inskickad som uppfyllde QC-kriterierna

5 november 2026

Första postat (Faktisk)

10 november 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

10 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

5 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • SKX16B01

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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