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URGO MICKAEL Filmogel, Topical Treatment of Onychomycosis (MICKAEL)

14 september 2026 bijgewerkt door: 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

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

54

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: URGO MICKAEL Filmogel
Local treatment of big toenails with positive culture
Apparaat: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Mycological cure rate evaluated at 6 months
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Mycological cure rate evaluated at 1 month
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 180 days
Percentage of clear toenail area in toenail with negative culture.
180 days
Investigator's opinion on treatment efficacy at 1 month
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Occurrence of device deficiencies at 6 months
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

CEN Biotech

Medewerkers

URGO RECHERCHE INNOVATION & DEVELOPPEMENT

Onderzoekers

  • Hoofdonderzoeker: Carole Perrin, MD, CEN

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

28 januari 2026

Primaire voltooiing (Geschat)

31 december 2026

Studie voltooiing (Geschat)

30 juni 2027

Studieregistratiedata

Eerst ingediend

14 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

14 september 2026

Eerst geplaatst (Werkelijk)

18 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

18 september 2026

Laatste update ingediend die voldeed aan QC-criteria

14 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • C1763
  • IDRCB no. 2025-A02049-40 (Andere identificatie: ANSM)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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