Onychomycosis of ToenailMICKAELNCT07828184
URGO MICKAEL Filmogel, Topical Treatment of Onychomycosis
A study testing URGO MICKAEL Filmogel in people with Onychomycosis of Toenail, run by CEN Biotech at 1 site in France.
Trial summary
The objective of this clinical study is to evaluate the performance of URGO MICKAEL Filmogel as a topical treatment for mild to moderate onychomycosis Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Onychomycosis of Toenail
- What is being tested?
- URGO MICKAEL Filmogel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jan 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Cen Experimental
Dijon
Carole PERRIN, MD, +33380680505, carole.perrin@groupecen.com
About this study
Official title: Performance and Safety of the Medical Device "URGO Ongles abimés 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
Read the 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.
- Conditions
- Onychomycosis of Toenail
- Being tested
- URGO MICKAEL Filmogel
- Keywords
- Onychomycosis, URGO MICKAEL Filmogel, damaged toenail
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
URGO MICKAEL FilmogelDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| URGO MICKAEL Filmogel | Experimental | Local treatment of big toenails with positive culture Receives: Device: URGO MICKAEL Filmogel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 180 days
Secondary outcomes (18)
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 180 days
Clear toenail area in toenail with negative culture at 6 months
Percentage of clear toenail area in toenail with negative culture.
Measured: 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?
Measured: 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?
Measured: 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?
Measured: 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?
Measured: 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?
Measured: 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?
Measured: 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?
Measured: 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?
Measured: 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?
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start28 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Onychomycosis of ToenailStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CEN Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- URGO RECHERCHE INNOVATION & DEVELOPPEMENT
- Responsible party
- Sponsor
- Investigators
- Carole Perrin, MD, Principal investigator, CEN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07828184
- Sponsor's protocol ID
- C1763
- Other IDs
- IDRCB no. 2025-A02049-40
- Acronym
- MICKAEL
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The informed consent obtained from participants does not include provisions for sharing individual participant data with external researchers
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance and Safety of the Medical Device "URGO Ongles abimés Par Mycoses et Traumatismes" in the Treatment of Mild to Moderate Distal Onychomycosis: An Open Study (MICKAEL)
- ClinicalTrials.gov ID
- NCT07828184
- Acronym / sponsor ID
- MICKAEL / C1763
- Conditions
- Onychomycosis of Toenail
- Keywords
- Onychomycosis, URGO MICKAEL Filmogel, damaged toenail
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- CEN BiotechIndustry (pharma, biotech, devices)
- Collaborators
- URGO RECHERCHE INNOVATION & DEVELOPPEMENT
- Study start
- 28 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 18 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this clinical study is to evaluate the performance of URGO MICKAEL Filmogel as a topical treatment for mild to moderate onychomycosis
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| URGO MICKAEL Filmogel | Experimental | Device: URGO MICKAEL FilmogelLocal treatment of big toenails with positive culture |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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…).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| URGO MICKAEL FilmogelThe 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. | Device | URGO MICKAEL Filmogel |
Primary outcome
Mycological cure rate evaluated at 6 months
Time frame: 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.
18 secondary outcomes
Mycological cure rate evaluated at 1 month
Time frame: 30 days
Mycological cure rate evaluated at 3 months
Time frame: 90 days
Change from baseline in onychomycosis severity at 1 month
Time frame: 30 days
Change from baseline in onychomycosis severity at 3 months
Time frame: 90 days
Change from baseline in onychomycosis severity at 6 months
Time frame: 180 days
Change from baseline in toenail condition at 1 month
Time frame: 30 days
Change from baseline in toenail condition at 3 months
Time frame: 90 days
Change from baseline in toenail condition at 6 months
Time frame: 180 days
Clear toenail area in toenail with negative culture at 6 months
Time frame: 180 days
Investigator's opinion on treatment efficacy at 1 month
Time frame: 30 days
Investigator's opinion on treatment efficacy at 3 months
Time frame: 90 days
Investigator's opinion on treatment efficacy at 6 months
Time frame: 180 days
Investigator's opinion on toenail appearance at 1 month
Time frame: 30 days
Investigator's opinion on toenail appearance at 3 months
Time frame: 90 days
Investigator's opinion on toenail appearance at 6 months
Time frame: 180 days
Patient's satisfaction with the treatment effectiveness at 1 month
Time frame: 30 days
Patient's satisfaction with the treatment effectiveness at 3 months
Time frame: 90 days
Patient's satisfaction with the treatment effectiveness at 6 months
Time frame: 180 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No. The informed consent obtained from participants does not include provisions for sharing individual participant data with external researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carole Perrin, MD principal investigator
CEN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing URGO MICKAEL Filmogel in people with Onychomycosis of Toenail, run by CEN Biotech at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amandine Fry (+33380680508, amandine.fry@groupecen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mycological cure rate evaluated at 6 months (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.