URGO MICKAEL Filmogel, Topical Treatment of Onychomycosis (MICKAEL)
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)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Amandine Fry
- Número de teléfono: +33380680508
- Correo electrónico: amandine.fry@groupecen.com
Ubicaciones de estudio
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Dijon, Francia
- Reclutamiento
- Cen Experimental
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Contacto:
- Carole PERRIN, MD
- Número de teléfono: +33380680505
- Correo electrónico: carole.perrin@groupecen.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- With 1 or 2 big toenail(s) damaged, which the clinical appearance of at least one great toenail is suggestive of onychomycosis.
- Big toenails with distal mild to moderate subungual onychomycosis (OSI Score < 16, no proximal or lunula involvement, and ≤50% nail involvement).
- Able to understand and comply with protocol requirements and instructions, including applying the device.
- Affiliated to a French Health insurance scheme.
- 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:
- Having a known allergy or hypersensitivity or contraindication to one of the constituents of UOA.
- 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.
- Having used any systemic antifungal treatment in the last 6 months before Baseline/pre-inclusion visit V0.
- Having used any topical antifungal treatment in the last 3 months before Baseline/pre-inclusion visit V0.
- 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…).
- With a condition or receiving medication which, according to the investigator's judgment, could jeopardize the safety of the subject.
- 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.
- May not respect the constraints imposed by the protocol.
- Enrolled in another clinical trial or being in a period of exclusion from a previous clinical trial.
- Woman of childbearing age (except menopausal, hysterectomised, sterilized) not using effective contraception (oral contraceptives, intra-uterine device, contraceptive implant, or condoms).
- 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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: URGO MICKAEL Filmogel
Local treatment of big toenails with positive culture
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Mycological cure rate evaluated at 6 months
Periodo de tiempo: 180 days
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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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Mycological cure rate evaluated at 1 month
Periodo de tiempo: 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
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Mycological cure rate evaluated at 3 months
Periodo de tiempo: 90 days
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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
|
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Change from baseline in onychomycosis severity at 1 month
Periodo de tiempo: 30 days
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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:
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30 days
|
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Change from baseline in onychomycosis severity at 3 months
Periodo de tiempo: 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:
|
90 days
|
|
Change from baseline in onychomycosis severity at 6 months
Periodo de tiempo: 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:
|
180 days
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Change from baseline in toenail condition at 1 month
Periodo de tiempo: 30 days
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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.
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30 days
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Change from baseline in toenail condition at 3 months
Periodo de tiempo: 90 days
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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
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Change from baseline in toenail condition at 6 months
Periodo de tiempo: 180 days
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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.
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180 days
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Clear toenail area in toenail with negative culture at 6 months
Periodo de tiempo: 180 days
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Percentage of clear toenail area in toenail with negative culture.
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180 days
|
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Investigator's opinion on treatment efficacy at 1 month
Periodo de tiempo: 30 days
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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?
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30 days
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Investigator's opinion on treatment efficacy at 3 months
Periodo de tiempo: 90 days
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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
|
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Investigator's opinion on treatment efficacy at 6 months
Periodo de tiempo: 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
|
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Investigator's opinion on toenail appearance at 1 month
Periodo de tiempo: 30 days
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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?
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30 days
|
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Investigator's opinion on toenail appearance at 3 months
Periodo de tiempo: 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?
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90 days
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Investigator's opinion on toenail appearance at 6 months
Periodo de tiempo: 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
|
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Patient's satisfaction with the treatment effectiveness at 1 month
Periodo de tiempo: 30 days
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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?
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30 days
|
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Patient's satisfaction with the treatment effectiveness at 3 months
Periodo de tiempo: 90 days
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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
|
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Patient's satisfaction with the treatment effectiveness at 6 months
Periodo de tiempo: 180 days
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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
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Occurrence of device deficiencies at 6 months
Periodo de tiempo: 180 days
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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.
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180 days
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Occurrence of adverse events at 6 months
Periodo de tiempo: 180 days
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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.
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180 days
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Improvement in quality of life at 6 months
Periodo de tiempo: 180 days
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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
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Carole Perrin, MD, CEN
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- C1763
- IDRCB no. 2025-A02049-40 (Otro identificador: ANSM)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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