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)

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

Study Overview

• Status: Recruiting
• Conditions: Onychomycosis of Toenail
• Intervention / Treatment: Device: URGO MICKAEL Filmogel

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amandine Fry; Phone Number: +33380680508; Email: amandine.fry@groupecen.com

Study Locations

• France
  • Dijon, France
    • Recruiting
    • Cen Experimental
    • Contact: Carole PERRIN, MD; Phone Number: +33380680505; Email: carole.perrin@groupecen.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: URGO MICKAEL Filmogel; Local treatment of big toenails with positive culture

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mycological cure rate evaluated at 6 months	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mycological cure rate evaluated at 1 month	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	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	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	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	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	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	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	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	Percentage of clear toenail area in toenail with negative culture.	180 days
Investigator's opinion on treatment efficacy at 1 month	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	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	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	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	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	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	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	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	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of device deficiencies at 6 months	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	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	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

Collaborators and Investigators

• Sponsor: CEN Biotech
• Collaborators: URGO RECHERCHE INNOVATION & DEVELOPPEMENT
• Investigators: Principal Investigator: Carole Perrin, MD, CEN

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: September 14, 2026
• First Submitted That Met QC Criteria: September 14, 2026
• First Posted (Actual): September 18, 2026

Study Record Updates

• Last Update Posted (Actual): September 18, 2026
• Last Update Submitted That Met QC Criteria: September 14, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Onychomycosis; URGO MICKAEL Filmogel; damaged toenail
• Additional Relevant MeSH Terms: Infections; Skin Diseases; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Nail Diseases; Mycoses; Dermatomycoses; Tinea; Skin and Connective Tissue Diseases; Onychomycosis
• Other Study ID Numbers: C1763; IDRCB no. 2025-A02049-40 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The informed consent obtained from participants does not include provisions for sharing individual participant data with external researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No