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URGO MICKAEL Filmogel, Topical Treatment of Onychomycosis (MICKAEL)

14 сентября 2026 г. обновлено: CEN Biotech

PERFORMANCE AND SAFETY OF THE MEDICAL DEVICE "URGO ONGLES ABIMES PAR MYCOSES ET TRAUMATISMES" IN THE TREATMENT OF MILD TO MODERATE DISTAL ONYCHOMYCOSIS: AN OPEN STUDY (MICKAEL)

The objective of this clinical study is to evaluate the performance of URGO MICKAEL Filmogel as a topical treatment for mild to moderate onychomycosis

Обзор исследования

Статус

Рекрутинг

Условия

Вмешательство/лечение

Подробное описание

Patients with a positive dermatophyte/fungal culture from a toenail sample are eligible for inclusion in the study. Patients apply the device under investigation daily to the affected toenails.

Patients are followed for up to 6 months, or until a negative fungal culture is obtained and the clinical appearance of the treated nails indicates resolution and significant improvement of the onychomycosis.

Four visits will be organized at the investigation site under the supervision of the principal investigator:

  • Baseline / Inclusion visit (V0)
  • 3 follow-up visits (V1, V2 and final V3) carried out 1, 3 and 6 months after the initiation of the treatment.

Тип исследования

Интервенционный

Регистрация (Оцененный)

54

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

Места учебы

  • Франция
      • Dijon, Франция
        • Рекрутинг
        • Cen Experimental
        • Контакт:

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Нет

Описание

Inclusion Criteria:

  1. With 1 or 2 big toenail(s) damaged, which the clinical appearance of at least one great toenail is suggestive of onychomycosis.
  2. Big toenails with distal mild to moderate subungual onychomycosis (OSI Score < 16, no proximal or lunula involvement, and ≤50% nail involvement).
  3. Able to understand and comply with protocol requirements and instructions, including applying the device.
  4. Affiliated to a French Health insurance scheme.
  5. Having signed an informed consent.

8. With 1 or 2 big toenail(s) damaged by onychomycosis confirmed by positive culture for dermatophytes / fungi on at least one big toenail.

Exclusion Criteria:

  1. Having a known allergy or hypersensitivity or contraindication to one of the constituents of UOA.
  2. The toenail(s) to be included in the study present(s) severe onychomycosis (which should be treated by systemic drug), or is/are unstructured, has/have severe microcracking or severe onycholysis, or the nail(s) or nail(s) contour has/have severe lesions.
  3. Having used any systemic antifungal treatment in the last 6 months before Baseline/pre-inclusion visit V0.
  4. Having used any topical antifungal treatment in the last 3 months before Baseline/pre-inclusion visit V0.
  5. With cutaneous pathology on studied zone (onychogryphosis, congenital ungual deformation, toe deformation or of the foot, hallux valgus, hallux rigidus, hallux extensus, toe claws or other pathologies than onychomycosis like angioma, dermatitis…).
  6. With a condition or receiving medication which, according to the investigator's judgment, could jeopardize the safety of the subject.
  7. Suffering from serious or progressive diseases (to investigator's discretion) such as uncontrolled diabetes, peripheral circulatory disease, lichen planus, immunosuppressive pathology, chronic venous insufficiency, Peripheral Arterial Obstructive Disease, delay, or lack of ungual growth etc.
  8. May not respect the constraints imposed by the protocol.
  9. Enrolled in another clinical trial or being in a period of exclusion from a previous clinical trial.
  10. Woman of childbearing age (except menopausal, hysterectomised, sterilized) not using effective contraception (oral contraceptives, intra-uterine device, contraceptive implant, or condoms).
  11. Person belonging to a population referred to in articles 64 (incapacitated subjects), 65 (minors), 66 (pregnant or breastfeeding women), 67 (persons performing mandatory military service, persons deprived of liberty, persons who, due to a judicial decision) and 68 (patients in emergency) of the MDR.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Н/Д
  • Интервенционная модель: Одногрупповое задание
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: URGO MICKAEL Filmogel
Local treatment of big toenails with positive culture
Устройство: URGO MICKAEL Filmogel
The device is used daily on 1 or 2 big toenails for up to 6 months The investigator may decide to discontinue treatment at after 1 or 3 months if the studied toenail(s) meet all the following criteria: 1. Negative dermatophyte/fungal culture. 2. Healthy appearance of the studied toenail(s), defined by a score of 0 ("none") for all the following items: onycholysis, nail dystrophy, nail discoloration, and nail thickening.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Mycological cure rate evaluated at 6 months
Временное ограничение: 180 days

Mycological cure is defined by a negative culture for dermatophytes/fungi from the big toenail under study.

A direct microscopic examination is performed after dissolving and staining the toenail sample using MYCETCOLOR® (Mycol60). The potassium hydroxide (KOH) test indicates the presence or absence of fungal elements. However, it does not provide information on the viability or etiology of any fungal elements detected.

Therefore, the samples are also placed on a suitable culture medium and incubated at a controlled temperature for several days to several weeks. Fungal growth is monitored, and any colonies that appear are identified microscopically to determine the specific fungal species involved.
180 days

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Mycological cure rate evaluated at 1 month
Временное ограничение: 30 days

A direct microscopic examination is performed after dissolving and staining the toenail sample using MYCETCOLOR® (Mycol60). The potassium hydroxide (KOH) test indicates the presence or absence of fungal elements. However, it does not provide information on the viability or etiology of any fungal elements detected.

Therefore, the samples are also placed on a suitable culture medium and incubated at a controlled temperature for several days to several weeks. Fungal growth is monitored, and any colonies that appear are identified microscopically to determine the specific fungal species involved.
30 days
Mycological cure rate evaluated at 3 months
Временное ограничение: 90 days

Mycological cure is defined by a negative culture for dermatophytes/fungi from the big toenail under study.

A direct microscopic examination is performed after dissolving and staining the toenail sample using MYCETCOLOR® (Mycol60). The potassium hydroxide (KOH) test indicates the presence or absence of fungal elements. However, it does not provide information on the viability or etiology of any fungal elements detected.

Therefore, the samples are also placed on a suitable culture medium and incubated at a controlled temperature for several days to several weeks. Fungal growth is monitored, and any colonies that appear are identified microscopically to determine the specific fungal species involved.
90 days
Change from baseline in onychomycosis severity at 1 month
Временное ограничение: 30 days

The severity of onychomycosis, assessed by a trained investigator, and using the global score of Onychomycosis Severity Index or OSI.

It provides a numerical score ranging from 0 (normal nail) to 35 (total dystrophy with full matrix involvement), based on three components:

  • Nail Involvement Area (1-5 points): percentage of the nail plate affected by onychomycosis estimated visually (0, [1-10], [11-25], [26-50], [51-75], [76-100]) and translated into a score;
  • Disease proximity to matrix from distal edge (<1/4, [1/4 to 1/2], [1/2 to 3/4], >3/4). The area score is then multiplied based on the location of the infection (x1 if the involvement is distal and/or lateral only; x2 if the involvement extends proximally and/or reaches the nail matrix);
  • Additional Points for Nail Features: +10 points if presence of hyperkeratosis ≥2 mm or dermatophytoma (i.e., longitudinal streak or patch).
30 days
Change from baseline in onychomycosis severity at 3 months
Временное ограничение: 90 days

The severity of onychomycosis, assessed by a trained investigator, and using the global score of Onychomycosis Severity Index or OSI.

It provides a numerical score ranging from 0 (normal nail) to 35 (total dystrophy with full matrix involvement), based on three components:

  • Nail Involvement Area (1-5 points): percentage of the nail plate affected by onychomycosis estimated visually (0, [1-10], [11-25], [26-50], [51-75], [76-100]) and translated into a score;
  • Disease proximity to matrix from distal edge (<1/4, [1/4 to 1/2], [1/2 to 3/4], >3/4). The area score is then multiplied based on the location of the infection (x1 if the involvement is distal and/or lateral only; x2 if the involvement extends proximally and/or reaches the nail matrix);
  • Additional Points for Nail Features: +10 points if presence of hyperkeratosis ≥2 mm or dermatophytoma (i.e., longitudinal streak or patch).
90 days
Change from baseline in onychomycosis severity at 6 months
Временное ограничение: 180 days

The severity of onychomycosis, assessed by a trained investigator, and using the global score of Onychomycosis Severity Index or OSI.

It provides a numerical score ranging from 0 (normal nail) to 35 (total dystrophy with full matrix involvement), based on three components:

  • Nail Involvement Area (1-5 points): percentage of the nail plate affected by onychomycosis estimated visually (0, [1-10], [11-25], [26-50], [51-75], [76-100]) and translated into a score;
  • Disease proximity to matrix from distal edge (<1/4, [1/4 to 1/2], [1/2 to 3/4], >3/4). The area score is then multiplied based on the location of the infection (x1 if the involvement is distal and/or lateral only; x2 if the involvement extends proximally and/or reaches the nail matrix);
  • Additional Points for Nail Features: +10 points if presence of hyperkeratosis ≥2 mm or dermatophytoma (i.e., longitudinal streak or patch).
180 days
Change from baseline in toenail condition at 1 month
Временное ограничение: 30 days
Onycholysis, nail dystrophy, nail discoloration, and nail thickening assessed using the following scores: 0 = none, 1 = very slight, 2 = slight, 3 = moderate, and 4 = severe.
30 days
Change from baseline in toenail condition at 3 months
Временное ограничение: 90 days
Onycholysis, nail dystrophy, nail discoloration, and nail thickening assessed using the following scores: 0 = none, 1 = very slight, 2 = slight, 3 = moderate, and 4 = severe.
90 days
Change from baseline in toenail condition at 6 months
Временное ограничение: 180 days
Onycholysis, nail dystrophy, nail discoloration, and nail thickening assessed using the following scores: 0 = none, 1 = very slight, 2 = slight, 3 = moderate, and 4 = severe.
180 days
Clear toenail area in toenail with negative culture at 6 months
Временное ограничение: 180 days
Percentage of clear toenail area in toenail with negative culture.
180 days
Investigator's opinion on treatment efficacy at 1 month
Временное ограничение: 30 days
Opinion is addressed using the Investigator's Global Impression of change with 7 modalities from "very much worse" to "very much improved", to respond to: What is your opinion regarding the improvement of the treated toenail?
30 days
Investigator's opinion on treatment efficacy at 3 months
Временное ограничение: 90 days
Opinion is addressed using the Investigator's Global Impression of change with 7 modalities from "very much worse" to "very much improved", to respond to: What is your opinion regarding the improvement of the treated toenail?
90 days
Investigator's opinion on treatment efficacy at 6 months
Временное ограничение: 180 days
Opinion is addressed using the Investigator's Global Impression of change with 7 modalities from "very much worse" to "very much improved", to respond to: What is your opinion regarding the improvement of the treated toenail?
180 days
Investigator's opinion on toenail appearance at 1 month
Временное ограничение: 30 days
Opinion is addressed using the Investigator's Global Impression of change with 7 modalities from "very much worse" to "very much improved", to respond to: What is your opinion regarding the appearance of the treated toenail?
30 days
Investigator's opinion on toenail appearance at 3 months
Временное ограничение: 90 days
Opinion is addressed using the Investigator's Global Impression of change with 7 modalities from "very much worse" to "very much improved", to respond to: What is your opinion regarding the appearance of the treated toenail?
90 days
Investigator's opinion on toenail appearance at 6 months
Временное ограничение: 180 days
Opinion is addressed using the Investigator's Global Impression of change with 7 modalities from "very much worse" to "very much improved", to respond to: What is your opinion regarding the appearance of the treated toenail?
180 days
Patient's satisfaction with the treatment effectiveness at 1 month
Временное ограничение: 30 days
Opinion is addressed using questions with 5 modalities from "Not at all satisfied" to "Very satisfied", to respond to: What is your opinion regarding the appearance of the treated toenail?
30 days
Patient's satisfaction with the treatment effectiveness at 3 months
Временное ограничение: 90 days
Opinion is addressed using questions with 5 modalities from "Not at all satisfied" to "Very satisfied", to respond to: What is your opinion regarding the appearance of the treated toenail?
90 days
Patient's satisfaction with the treatment effectiveness at 6 months
Временное ограничение: 180 days
Opinion is addressed using questions with 5 modalities from "Not at all satisfied" to "Very satisfied", to respond to: What is your opinion regarding the appearance of the treated toenail?
180 days

Другие показатели результатов

Мера результата
Мера Описание
Временное ограничение
Occurrence of device deficiencies at 6 months
Временное ограничение: 180 days
Percentage of patients reporting device deficiencies defined as any inadequacy in the identity, quality, durability, reliability, inadequacy of information provided by the manufacturer, including labeling.
180 days
Occurrence of adverse events at 6 months
Временное ограничение: 180 days
Adverse events are coded using the MedDRA dictionary. Adverse events are classified according to their seriousness, their relationship to the device, and for adverse device effects, whether they are expected or unexpected.
180 days
Improvement in quality of life at 6 months
Временное ограничение: 180 days

Quality of life is assessed using a questionnaire composed of the following three scales:

Nail Distress Scale: Subjects indicate how often they experience nail-related distress during the past week using a 5-point scale (4 = strongly disagree; 3 = disagree; 2 = neither agree nor disagree; 1 = agree; 0 = strongly agree).

Nail Symptoms Scale: Subjects indicate how concerned they have been about their nail condition during the past week using a 5-point scale (4 = not at all; 3 = a little; 2 = somewhat; 1 = very; 0 = extremely).

Physical Scale: Subjects indicate how their nail condition interferes with their activities during the past week using a 5-point scale (4 = never; 3 = rarely; 2 = sometimes; 1 = often; 0 = always).

The raw scores each scale are added together to produce a total raw score which is converted to a score ranging from 0 (worst) to 100 (best), with higher scores indicating better outcomes.
180 days

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

CEN Biotech

Соавторы

URGO RECHERCHE INNOVATION & DEVELOPPEMENT

Следователи

  • Главный следователь: Carole Perrin, MD, CEN

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

28 января 2026 г.

Первичное завершение (Оцененный)

31 декабря 2026 г.

Завершение исследования (Оцененный)

30 июня 2027 г.

Даты регистрации исследования

Первый отправленный

14 сентября 2026 г.

Впервые представлено, что соответствует критериям контроля качества

14 сентября 2026 г.

Первый опубликованный (Действительный)

18 сентября 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

18 сентября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

14 сентября 2026 г.

Последняя проверка

1 сентября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • C1763
  • IDRCB no. 2025-A02049-40 (Другой идентификатор: ANSM)

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Описание плана IPD

The informed consent obtained from participants does not include provisions for sharing individual participant data with external researchers

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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