Can a daily nail film clear stubborn toenail fungus?
NCT ID NCT07828184
First seen Sep 18, 2026 · Last updated Sep 18, 2026
Summary
Researchers are testing a topical filmogel device called URGO MICKAEL on mild to moderate toenail fungus. About 54 adults with one or two damaged big toenails apply the device daily for up to six months. The study measures whether fungal cultures from the treated nail turn negative, checking at one month and again at six months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a topical filmogel device applied daily to the big toenail
- What this could lead to
- If it works, people with mild to moderate toenail fungus could have a simple daily topical option that avoids pills and their side effects.
- What could go wrong
- This is a small, open-label study with no comparison group, so results may not hold up in larger controlled trials. Toenail fungus is slow to treat, and six months of daily application may not clear it.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 54 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cen Experimental
RECRUITINGDijon, France
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