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 study about?

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.

1 joining the study

The study involves participants aged 6 to 17 years with a specific type of nail infection called distal subungual onychomycosis. This condition affects the toenails, particularly the great toenail, with 20% to 50% of the nail involved.

Participants must have a positive test for a type of fungus called dermatophyte and a positive KOH microscopy test from the affected toenail.

2 treatment phase

Participants will use a topical solution called MOB015B, which contains the active ingredient terbinafine. This solution is applied directly to the affected toenail.

The solution is a cutaneous solution, meaning it is intended for use on the skin or nails.

3 application instructions

The solution should be applied as directed by the study protocol. The frequency and specific instructions for application will be provided by the study team.

4 monitoring and assessment

Participants will be monitored throughout the study to evaluate the tolerability, safety, and effectiveness of the treatment.

The primary goal is to achieve treatment success, defined as 0-10% clinical disease involvement of the target toenail and mycological cure, by Week 48.

5 completion of the study

The study is expected to conclude by September 2026. Participants will have regular assessments to track progress and any changes in the condition of the toenail.

Who Can Join the Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Gyncentrum Sp. z o.o.	Katowice	Poland

Other Sites

Site Name	City	Country
Copernicus Podmiot Leczniczy Sp. z o.o.	Gdansk	Poland
Gentofte Hospital	Hellerup	Denmark
IRCCS Azienda Ospedaliero Universitaria – Policlinico di Sant’Orsola	Bologna	Italy
Nyfl Ssnxyuqc Oidffdu Dutsybjugurkvvu Dcmacb	Bialystok	Poland
Pcbwgnrzd Iumikzwi Mxkaaxwh Mnwfabltufeo Svyit Wermvynmcvsw I Aetocnemrbbwm	Warsaw	Poland

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	02.10.2023
Iceland	Not yet recruiting	02.10.2023
Italy	Recruiting	02.10.2023
Poland	Recruiting	02.10.2023

Trial locations

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.

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 ID:

2024-513214-34-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety and Effectiveness of Terbinafine Solution for Treating Mild to Moderate Nail Fungus in Children Aged 6-17 Years

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?