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Идёт набор NCT04042857

Safety and Efficacy of Next Science Gel on Toenail Fungus

Без фазы С лечением Onychomycosis of Toenail

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Next Science Treatment Gel.
Кому может быть актуально
Состояния в реестре: Onychomycosis of Toenail. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Safety and Efficacy of Next Science Wound Gel in the Treatment of Mild to Moderate Distal Subungual Onychomycosis (DSO): An Open-Label Pilot Study

Обзор

This is a 52 week, 20-patient open-label pilot study on the safety and efficacy of Next Science Wound gel in the treatment of mild to moderate Distal Subungual Onychomycosis.

Подробное описание

Patients will apply Next Science Wound Gel daily to each study treatment hallux nail for 48 weeks once approved for participation. Analysis will be attained via potassium hydroxide examination (KOH test), nail culture, PCR analysis, and photographic imaging. Subjects may have both hallux nails sampled at screening for culture and KOH testing if both hallux nails appear to meet the criteria for study inclusion. Only subjects with both a positive culture and KOH examination will start study treatment. Subjects may have repeat KOH and culture testing both performed if the first screening test results in at least one of the tests being negative. At investigator's discretion, other affected toenails besides the study target hallux nail may be treated but will not be included for analysis. Patients will come for in-clinic visits at screening, baseline/randomization visit/week 0, week 4, week 8, week 12, week 24, week 36, week 48, and week 52.

If subjects achieve complete cure (as defined by mycological cure and 0% nail involvement) prior to Week 48, patients will be encouraged to continue in the trial with active treatment for the full protocol.

Вмешательства

  • Устройство Next Science Treatment Gel
    Next Science Treatment Gel will be applied after nail surface nail-filing and/or debridement.

Первичные конечные точки

  • Mycological Cure at 48 Weeks [Срок оценки: Baseline to 48 Weeks]
  • Clinical Efficacy at 48 Weeks [Срок оценки: Baseline to 48 Weeks]
Вторичные конечные точки (11)
  • Complete Cure at Week 48 [Срок оценки: Baseline to 48 Weeks]
  • Complete Cure at Week 52 [Срок оценки: Baseline to 52 Weeks]
  • Almost Complete Cure at Week 48 [Срок оценки: Baseline to 48 Weeks]
  • Almost Complete Cure at Week 52 [Срок оценки: Baseline to Week 52]
  • Time to Complete Cure [Срок оценки: Baseline to 52 Weeks]
  • Time to Almost Complete Cure [Срок оценки: Baseline to 52 Weeks]
  • Percent Change in Area of Nail Involvement [Срок оценки: Baseline to 52 Weeks]
  • Growth of Clear Nail [Срок оценки: Baseline to 52 Weeks]
  • Mycological Cure Rate [Срок оценки: Baseline to 52 Weeks]
  • Dermatopyhyte Identification and Characterization [Срок оценки: Baseline to 52 Weeks]
  • Overall Fungal Species [Срок оценки: Baseline to 52 Weeks]

Критерии участия

Критерии включения

  • Ages 18 years old and above
  • Established and active diagnosis of distal subungual onychomycosis of at least one hallux nail affecting 20-75% of the hallux nail
  • Positive culture for dermatophytes and positive potassium hydroxide examination
  • Provide signed and dated informed consent
  • Willing to comply with all study procedures and available for the duration of the study

Критерии исключения

  • Known allergic reaction to the study products
  • Unable to provide signed and dated informed consent form
  • Unable or unwilling to comply with all study procedures and/or unavailable for duration of the study
  • Thickness of mycotic nail is greater than 3mm
  • Less than 2mm of clear nail at the proximal aspect
  • History of rheumatoid arthritis
  • Subject with any other disease or condition other than DSO that would affect nail appearance or interfere with image analysis
  • Unwilling or unable to limit use of nail polish for duration of study
  • Known history of PVD, immune system concerns, or ongoing chemotherapy
  • Severe moccasin tinea pedis
  • Prior systemic antifungal drugs 6 months before study start date
  • Prior topical therapy for toenail fungus 2 months before study start date
  • Any diseases or circumstances in which the patient should not participate in the study in the opinion of the investigator

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Doctors Research Network — South Miami

Идентификаторы

NCT: NCT04042857 · CSP-010

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗