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Идёт набор NCT06689852

CLINICAL INVESTIGATION FOR THE EVALUATION OF EFFICACY AND SAFETY OF TWO PRODUCTS FOR THE TREATMENT OF ONYCHOMYCOSIS

Без фазы С лечением Onychomycosis

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: Enriched, Loceryl 5%.
Кому может быть актуально
Состояния в реестре: Onychomycosis. Базовые параметры: 18 лет — 70 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
Франция
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

MULTICENTRIC, RANDOMIZED, EVALUATOR BLINDED CLINICAL INVESTIGATION FOR THE EVALUATION OF EFFICACY AND SAFETY OF TWO PRODUCTS FOR THE TREATMENT OF ONYCHOMYCOSIS

Обзор

The efficacy and safety of ENRICHED (X92001591) will be evaluated in a multicentric, randomized, evaluator blinded clinical investigation in 88 patients.

Подробное описание

Subjects will be treated with either the test medical device (ENRICHED X92001591) or the reference product (Loceryl, 5% amorolfine) for a period of 9 months. The primary objective of the investigation will be increase of % of healthy nail surface versus baseline, as evaluated by a blinded investigator. Subjects will be followed up for a period of 9 months, with visits at D0 (baseline), D90 (month 3), D180 (month 6) and D270 (month 9).

Вмешательства

  • Устройство Enriched
    To be used twice a day
  • Препарат Loceryl 5%
    To be used once a week

Первичные конечные точки

  • Blinded evaluation of the percentage of healthy nail surface [Срок оценки: 270 days]
Вторичные конечные точки (7)
  • Percentage of healthy surface (performance) [Срок оценки: 90 days, 180 days]
  • Mirobiological efficacy ; KOH staining (Performance) [Срок оценки: 270 days]
  • Clinical efficacy: Visual appearance of nail (including onycholysis, nail dystrophy, nail discoloration and nail thickening) (Performance) [Срок оценки: 90 days, 180 days, 270 days]
  • Clinical efficacy: onychomycosis evolution (Performance) [Срок оценки: 90 days, 180 days, 270 days]
  • Impact on quality of life (Performance) [Срок оценки: 180 days, 270 days]
  • Subjective evaluation questionnaire for the patient (Performance) [Срок оценки: 14 days, 90 days, 180 days, 270 days]
  • Evaluation of tolerance [Срок оценки: 90 days, 180 days, 270 days]

Критерии участия

Критерии включения

  • 1\. Patient having given freely her/his informed, written consent. 2. Patient having a good general health. 3. Age: between 18 and 70 years; 4. Patient with superficial onychomycosis on at least one great toenail or fingernail (for at least 10% in each arm) or light to moderate disto-lateral onychomycosis (without matrix involvement and involvement \<2/3 of the tablets).

5\. Patient with positive KOH staining. 6. Patient cooperative and aware of the products modalities of use and the necessity and duration of the controls so that perfect adhesion to the protocol can be expected.

7\. Patient being psychologically able to understand information and to give their/his/her consent.

8\. Patient having stopped any systemic antifungal treatment since at least 6 months before screening and/or any topical antifungal treatment since at least 3 months before screening.

9\. Patient who agree to refrain from receiving pedicure/manicure, artificial nails and/or cosmetic nail varnish or other medication on the nail being treated for the entire study duration.

10\. Female of childbearing potential should use a contraceptive regimen recognized as effective since at least 12 weeks before screening visit, during all the study and at least 1 month after study end.

Критерии исключения

\- 1. Pregnant, breastfeeding woman or woman planning a pregnancy during the study; 2. Patient considered by the investigator likely to be non-compliant with the protocol. 3. Patient enrolled in another clinical trial or which exclusion period is not over. 4. Patient with a condition or receiving a medication which, in the investigator's judgment, put the patient at undue risk; 5. Patient suffering from a severe or progressive disease (to investigator's discretion) such as uncontrolled diabetes, peripheral circulatory disease, HIV, psoriasis, lichen planus, immunosuppressive pathology… 6. Patient having a known allergy or hypersensitivity to one of the constituents of the tested products.

7\. Patient with cutaneous pathology on studied zone (other than onychomycosis like angioma, dermatitis…).

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Франция · 1 центр
  • Eurofins Dermscan Pharmascan — Villeurbanne

Идентификаторы

NCT: NCT06689852 · 23E1728

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗