Safety and Efficacy Study of SKX-16 in Participants With Mild to Moderate Distal Subungual Onychomycosis
5 novembre 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
204
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Mehria Afzal Patient Recruitment and Site Engagement Specialist
- Numéro de téléphone: 326 866-575-3111
- E-mail: mafzal@inderocro.com
Lieux d'étude
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California
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Los Angeles, California, États-Unis, 900045
- SKX16B01 Clinical Study - Site 105
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Contact:
- Mehria Afzal Pts Recruitment and Site Engagement Specialist, Indero (CRO)
- Numéro de téléphone: 866-575-3111
- E-mail: mafzal@inderocro.com
-
San Francisco, California, États-Unis, 94115
- SKX16B01 Clinical Study - Site 101
-
Contact:
- Mehria Afzal Pts Recruitment and Site Engagement Specialist, Indero (CRO)
- Numéro de téléphone: 866-575-3111
- E-mail: mafzal@inderocro.com
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-
Florida
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Miami, Florida, États-Unis, 11760
- SKX16B01 Clinical Study - Site 104
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Contact:
- Mehria Afzal Pts Recruitment and Site Engagement Specialist, Indero (CRO)
- Numéro de téléphone: 866-575-3111
- E-mail: mafzal@inderocro.com
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Miami, Florida, États-Unis, 33126
- SKX16B01 Clinical Study - Site 109
-
Contact:
- Mehria Afzal Pts Recruitment and Site Engagement Specialist, Indero (CRO)
- Numéro de téléphone: 866-575-3111
- E-mail: mafzal@inderocro.com
-
-
Texas
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College Station, Texas, États-Unis, 77845
- SKX16B01 Clinical Study - Site 111
-
Contact:
- Mehria Afzal Pts Recruitment and Site Engagement Specialist, Indero (CRO)
- Numéro de téléphone: 866-575-3111
- E-mail: mafzal@inderocro.com
-
Houston, Texas, États-Unis, 77027
- SKX16B01 Clinical Study - Site 119
-
Contact:
- Mehria Afzal Pts Recruitment and Site Engagement Specialist, Indero (CRO)
- Numéro de téléphone: 866-575-3111
- E-mail: mafzal@inderocro.com
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 70 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Active Arm
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. |
|
Comparateur placebo: Vehicle Arm
Vehicle solution that does not contain active ingredients. |
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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Complete Cure at Week 56
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Mycological Cure at Week 56
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 56 weeks
|
Clear nail growth of the target toenail at Week 56 |
56 weeks
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
24 novembre 2026
Achèvement primaire (Estimé)
23 septembre 2028
Achèvement de l'étude (Estimé)
21 octobre 2028
Dates d'inscription aux études
Première soumission
15 octobre 2026
Première soumission répondant aux critères de contrôle qualité
5 novembre 2026
Première publication (Réel)
10 novembre 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
10 novembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
5 novembre 2026
Dernière vérification
1 novembre 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- SKX16B01
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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