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)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Amandine Fry
- Telefonnummer: +33380680508
- E-mail: amandine.fry@groupecen.com
Studiesteder
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Dijon, Frankrig
- Rekruttering
- Cen Experimental
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Kontakt:
- Carole PERRIN, MD
- Telefonnummer: +33380680505
- E-mail: carole.perrin@groupecen.com
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Mycological cure rate evaluated at 6 months
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Mycological cure rate evaluated at 1 month
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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:
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30 days
|
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Change from baseline in onychomycosis severity at 3 months
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
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Change from baseline in toenail condition at 6 months
Tidsramme: 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
|
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Clear toenail area in toenail with negative culture at 6 months
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
|
Investigator's opinion on treatment efficacy at 6 months
Tidsramme: 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
Tidsramme: 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?
|
30 days
|
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Investigator's opinion on toenail appearance at 3 months
Tidsramme: 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
|
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Investigator's opinion on toenail appearance at 6 months
Tidsramme: 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
Tidsramme: 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?
|
30 days
|
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Patient's satisfaction with the treatment effectiveness at 3 months
Tidsramme: 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
Tidsramme: 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
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Occurrence of device deficiencies at 6 months
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Carole Perrin, MD, CEN
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- C1763
- IDRCB no. 2025-A02049-40 (Anden identifikator: ANSM)
Plan for individuelle deltagerdata (IPD)
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IPD-planbeskrivelse
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