Topical Filmogel for toenail fungus
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)
Run by CEN Biotech · NCT07828184 · Data updated 2026-11-12
The study tests URGO MICKAEL Filmogel as a daily topical treatment for mild to moderate toenail fungus in adults.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 54 (estimated) |
| Sponsor | CEN Biotech Industry-sponsored |
| Locations | 1 site (Dijon) |
| Status | Recruiting |
| Started | January 28, 2026 |
| Main results expected | December 31, 2026 |
| Study ends | June 30, 2027 |
| Registry record updated | September 22, 2026 |
| Trial ID | NCT07828184 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with 1–2 damaged big toenails showing mild to moderate subungual onychomycosis and a positive fungal culture.
✕Probably not a fit
Participants with severe onychomycosis requiring systemic treatment or those with contraindications to the product may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study evaluates a topical filmogel applied daily to affected toenails in people with confirmed dermatophyte or fungal infection. Participants are followed for up to six months, or until two conditions are met: a negative fungal culture and clear clinical improvement. Four visits are scheduled: baseline, and at 1, 3, and 6 months. The goal is to see if the product can resolve infection and improve nail appearance without systemic therapy.
Why it matters
Potential benefit: If successful, participants may experience clearance of the infection and improved nail health without oral medications.
How similar studies have gone: Previous topical antifungal approaches have shown variable success; this study tests a specific filmogel formulation.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Cen Experimental
Dijon, France Recruiting
Study contacts
- Principal investigator: Carole Perrin, MD — Cen
- Study coordinator: Amandine Fry
- Email: amandine.fry@groupecen.com
- Phone: +33380680508
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Treatment of toenail fungus with Next Science Gel
This study is testing if a new gel can safely and effectively treat toenail fungus in people with mild to moderate cases.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.