Safety and Efficacy Study of SKX-16 in Participants With Mild to Moderate Distal Subungual Onychomycosis
5 de noviembre de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
204
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Mehria Afzal Patient Recruitment and Site Engagement Specialist
- Número de teléfono: 326 866-575-3111
- Correo electrónico: mafzal@inderocro.com
Ubicaciones de estudio
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California
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Los Angeles, California, Estados Unidos, 900045
- SKX16B01 Clinical Study - Site 105
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Contacto:
- Mehria Afzal Pts Recruitment and Site Engagement Specialist, Indero (CRO)
- Número de teléfono: 866-575-3111
- Correo electrónico: mafzal@inderocro.com
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San Francisco, California, Estados Unidos, 94115
- SKX16B01 Clinical Study - Site 101
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Contacto:
- Mehria Afzal Pts Recruitment and Site Engagement Specialist, Indero (CRO)
- Número de teléfono: 866-575-3111
- Correo electrónico: mafzal@inderocro.com
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Florida
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Miami, Florida, Estados Unidos, 11760
- SKX16B01 Clinical Study - Site 104
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Contacto:
- Mehria Afzal Pts Recruitment and Site Engagement Specialist, Indero (CRO)
- Número de teléfono: 866-575-3111
- Correo electrónico: mafzal@inderocro.com
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Miami, Florida, Estados Unidos, 33126
- SKX16B01 Clinical Study - Site 109
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Contacto:
- Mehria Afzal Pts Recruitment and Site Engagement Specialist, Indero (CRO)
- Número de teléfono: 866-575-3111
- Correo electrónico: mafzal@inderocro.com
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Texas
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College Station, Texas, Estados Unidos, 77845
- SKX16B01 Clinical Study - Site 111
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Contacto:
- Mehria Afzal Pts Recruitment and Site Engagement Specialist, Indero (CRO)
- Número de teléfono: 866-575-3111
- Correo electrónico: mafzal@inderocro.com
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Houston, Texas, Estados Unidos, 77027
- SKX16B01 Clinical Study - Site 119
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Contacto:
- Mehria Afzal Pts Recruitment and Site Engagement Specialist, Indero (CRO)
- Número de teléfono: 866-575-3111
- Correo electrónico: mafzal@inderocro.com
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 70 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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. |
|
Comparador de placebos: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Complete Cure at Week 56
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Mycological Cure at Week 56
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 56 weeks
|
Proportion of participants with < 10% of affected target toenail area and mycological cure of the target toenail at Week 56 |
56 weeks
|
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Percent Change in Affected Nail Area
Periodo de tiempo: Baseline and Week 56
|
Percent change from baseline in percentage of affected target toenail area at Week 56 |
Baseline and Week 56
|
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Clear Nail Growth at Week 56
Periodo de tiempo: 56 weeks
|
Clear nail growth of the target toenail at Week 56 |
56 weeks
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
24 de noviembre de 2026
Finalización primaria (Estimado)
23 de septiembre de 2028
Finalización del estudio (Estimado)
21 de octubre de 2028
Fechas de registro del estudio
Enviado por primera vez
15 de octubre de 2026
Primero enviado que cumplió con los criterios de control de calidad
5 de noviembre de 2026
Publicado por primera vez (Actual)
10 de noviembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
10 de noviembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
5 de noviembre de 2026
Última verificación
1 de noviembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SKX16B01
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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