Safety and Efficacy Study of SKX-16 in Participants With Mild to Moderate Distal Subungual Onychomycosis
5 de novembro de 2026 atualizado 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.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
204
Estágio
- Fase 2
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Mehria Afzal Patient Recruitment and Site Engagement Specialist
- Número de telefone: 326 866-575-3111
- E-mail: mafzal@inderocro.com
Locais de estudo
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California
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Los Angeles, California, Estados Unidos, 900045
- SKX16B01 Clinical Study - Site 105
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Contato:
- Mehria Afzal Pts Recruitment and Site Engagement Specialist, Indero (CRO)
- Número de telefone: 866-575-3111
- E-mail: mafzal@inderocro.com
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San Francisco, California, Estados Unidos, 94115
- SKX16B01 Clinical Study - Site 101
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Contato:
- Mehria Afzal Pts Recruitment and Site Engagement Specialist, Indero (CRO)
- Número de telefone: 866-575-3111
- E-mail: 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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Contato:
- Mehria Afzal Pts Recruitment and Site Engagement Specialist, Indero (CRO)
- Número de telefone: 866-575-3111
- E-mail: mafzal@inderocro.com
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Miami, Florida, Estados Unidos, 33126
- SKX16B01 Clinical Study - Site 109
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Contato:
- Mehria Afzal Pts Recruitment and Site Engagement Specialist, Indero (CRO)
- Número de telefone: 866-575-3111
- E-mail: 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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Contato:
- Mehria Afzal Pts Recruitment and Site Engagement Specialist, Indero (CRO)
- Número de telefone: 866-575-3111
- E-mail: mafzal@inderocro.com
-
Houston, Texas, Estados Unidos, 77027
- SKX16B01 Clinical Study - Site 119
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Contato:
- Mehria Afzal Pts Recruitment and Site Engagement Specialist, Indero (CRO)
- Número de telefone: 866-575-3111
- E-mail: mafzal@inderocro.com
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 70 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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 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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Complete Cure at Week 56
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Mycological Cure at Week 56
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 56 weeks
|
Clear nail growth of the target toenail at Week 56 |
56 weeks
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
24 de novembro de 2026
Conclusão Primária (Estimado)
23 de setembro de 2028
Conclusão do estudo (Estimado)
21 de outubro de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
15 de outubro de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
5 de novembro de 2026
Primeira postagem (Real)
10 de novembro de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
10 de novembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
5 de novembro de 2026
Última verificação
1 de novembro de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- SKX16B01
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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