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URGO MICKAEL Filmogel, Topical Treatment of Onychomycosis (MICKAEL)

14 settembre 2026 aggiornato da: 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

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

54

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: URGO MICKAEL Filmogel
Local treatment of big toenails with positive culture
Dispositivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mycological cure rate evaluated at 6 months
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mycological cure rate evaluated at 1 month
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 180 days
Percentage of clear toenail area in toenail with negative culture.
180 days
Investigator's opinion on treatment efficacy at 1 month
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Occurrence of device deficiencies at 6 months
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

CEN Biotech

Collaboratori

URGO RECHERCHE INNOVATION & DEVELOPPEMENT

Investigatori

  • Investigatore principale: Carole Perrin, MD, CEN

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

28 gennaio 2026

Completamento primario (Stimato)

31 dicembre 2026

Completamento dello studio (Stimato)

30 giugno 2027

Date di iscrizione allo studio

Primo inviato

14 settembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

14 settembre 2026

Primo Inserito (Effettivo)

18 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

18 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

14 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • C1763
  • IDRCB no. 2025-A02049-40 (Altro identificatore: ANSM)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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