Copernicus Podmiot Leczniczy Sp. z o.o.
Gdansk, Poland
Recruiting
Study on the Safety and Effectiveness of Terbinafine Solution for Treating Mild to Moderate Nail Fungus in Children Aged 6-17 Years
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What is this trial about?
A plain-language summary of the goals, design and what participants do
This clinical trial is focused on studying a condition known as distal subungual onychomycosis, which is a type of fungal infection affecting the toenails. The trial will use a treatment called MOB015B, a topical solution applied directly to the skin. The purpose of the study is to evaluate how well this treatment works, as well as its safety and tolerability, in children aged 6 to 17 years who have mild to moderate cases of this nail infection.
Participants in the study will apply the MOB015B solution to the affected toenail over a period of time. The study will monitor the progress of the treatment to see if it leads to a reduction in the infection and ultimately a cure. The trial will also assess the safety of the treatment to ensure it is well-tolerated by the participants. The study aims to achieve treatment success, which is defined as a significant reduction in the infection and a cure of the affected toenail.
The trial will take place over several months, with regular check-ins to monitor the condition of the toenail and the overall health of the participants. The study will conclude with an evaluation of the treatment's effectiveness and safety, providing valuable information on the use of MOB015B for treating distal subungual onychomycosis in children. Participants will be closely observed to ensure their well-being throughout the study period.
The research process
The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
6 criteria
- Children who are between 6 and 17 years old, including both boys and girls.
- Have a condition called distal subungual onychomycosis on at least one big toenail. This means a fungal infection under the nail, affecting 20% to 50% of the nail, with at least 3 mm of healthy nail near the base.
- Have a positive test result for a type of fungus called dermatophyte and a positive KOH microscopy test, which checks for fungus in the nail sample.
- Have signed a written agreement to participate, known as informed assent or consent.
- Show that the big toenail can grow, such as by cutting toenails at least once a month.
- Be able to follow the study rules and procedures, as judged by the study doctor.
Who cannot join the trial?
8 criteria
- Children younger than 2 years old cannot participate.
- Individuals who are not diagnosed with Distal Subungual Onychomycosis cannot participate. This is a type of nail infection caused by a fungus.
- Participants who are unable to follow the study procedures or instructions cannot participate.
- Individuals with other medical conditions that might interfere with the study cannot participate.
- Participants who are currently using other treatments for nail infections cannot participate.
- Individuals who have allergies to the study medication or its ingredients cannot participate.
- Pregnant or breastfeeding individuals cannot participate.
- Participants who have taken part in another clinical trial recently cannot participate.
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Verified sites
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Verified Verified Gentofte Hospital
Hellerup, DenmarkVerified IRCCS Azienda Ospedaliero Universitaria - Policlinico di Sant'Orsola
Bologna, Italy
Trial locations
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Investigated drugs
MOB015B is a topical solution being tested for its ability to treat mild to moderate distal subungual onychomycosis, a type of fungal nail infection, in children aged 6 to 17 years. The study aims to determine how well this solution works in curing the infection, both in terms of eliminating the fungus and improving the appearance of the affected nails.
What is already known about the treatment
MOB015B – This medication is administered topically as a solution and is currently being studied in clinical trials for its safety, tolerability, and effectiveness in treating mild to moderate distal subungual onychomycosis, a fungal infection of the nails, in children aged 6-17 years. The medication is still under investigation, and its status in medical literature is primarily within the context of these ongoing studies. The main therapeutic indication is to treat nail fungus, aiming for mycological, clinical, and complete cure. At the molecular level, it works by inhibiting the growth of fungi, disrupting their cell membranes. It is classified pharmacologically as an antifungal agent.
Investigated diseases
Distal Subungual Onychomycosis – This is a common fungal infection that affects the toenails, particularly the area under the nail plate. It is characterized by the nail becoming discolored, thickened, and brittle, often with a yellow or white appearance. The infection typically starts at the tip of the nail and gradually spreads towards the cuticle. As the condition progresses, the nail may become distorted in shape and may separate from the nail bed. It is often caused by dermatophyte fungi, which thrive in warm, moist environments. The condition can be persistent and may affect one or more toenails.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IITrial ID2024-513214-34-00Estimated enrolment32 patientsSponsorMoberg Pharma AB (publ)
sourced from the EU Clinical Trials Register and site verification
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