Aún no reclutaNCT07929844Registro de ClinicalTrials.gov

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

Onychomycosis of Toenails

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LO ESENCIAL

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio: De intervención
Fase: Fase 2
Rango de edad: 18 años - 70 años
Sexo admitido: Todos los sexos
Voluntarios sanos: No aceptados
Participantes: 204 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

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.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

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.

Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación: Asignación al azar
Enmascaramiento: Enmascaramiento cuádruple

Active Arm

SKX-16 (Luliconazole 10% Solution)

Drug: SKX-16 (Luliconazole 10% Solution)

Vehicle Arm

Vehicle solution that does not contain active ingredients.

Drug: Vehicle solution

SKX-16 (Luliconazole 10% Solution) DRUG

Applied topically once daily for 52 weeks to all affected toenails identified by the investigator, followed by a Week 56 follow-up visit.

Vehicle solution DRUG

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.

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Complete Cure at Week 56

Plazo: 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)

Medidas secundarias

Mycological Cure at Week 56

Plazo: 56 weeks

Proportion of participants with mycological cure (negative KOH microscopy and negative culture) of the target toenail at Week 56

Clinical Cure at Week 56

Plazo: 56 weeks

Proportion of participants with clinical cure (completely clear target great toenail as assessed by the investigator) at Week 56

≤5% Affected Nail Area + Mycological Cure at Week 56

Plazo: 56 weeks

Proportion of participants with ≤ 5% of affected target toenail area and mycological cure of the target toenail at Week 56

<10% Affected Nail Area + Mycological Cure at Week 56

Plazo: 56 weeks

Proportion of participants with \< 10% of affected target toenail area and mycological cure of the target toenail at Week 56

Percent Change in Affected Nail Area

Plazo: Baseline and Week 56

Percent change from baseline in percentage of affected target toenail area at Week 56

Clear Nail Growth at Week 56

Plazo: 56 weeks

Clear nail growth of the target toenail at Week 56

El registro no indica resultados publicados.

Revisa las tablas completas y sus limitaciones en el registro oficial.

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Centros de investigación (6)

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Buscar un centro en este estudio

6 centros

SKX16B01 Clinical Study - Site 105Los Angeles, California, United StatesEstado desconocido