Ongoing Clinical Trials for Onychomycosis
There are currently 2 clinical trials investigating new treatments for fungal nail infections. These studies are testing topical medications applied directly to affected nails, with trials taking place in Spain, Denmark, Iceland, Italy, and Poland. The research focuses on evaluating both the effectiveness and safety of antifungal solutions for patients of different age groups.
Clinical trial locations
- Denmark
- Iceland
- Italy
- Poland
- Spain
Study on the Effect of Ciclopirox in Treating Nail Fungal Infection in Patients
This trial is investigating DexULac, a medicated nail lacquer containing the active ingredient ciclopirox, for treating fungal nail infections. The study takes place in Spain and focuses on understanding how the treatment affects both the severity of the infection and the quality of life of those living with this condition.
Who can participate: The study is looking for adults between 18 and 75 years of age who have been diagnosed with mild to moderate nail fungal infection within the last 6 months. The infection should affect between 10% and 40% of the nail and must be caused by dermatophyte fungi. Women of childbearing age must have a negative pregnancy test and agree to use effective birth control from 14 days before treatment starts until 4 weeks after the last dose.
Who cannot participate: The trial excludes individuals who do not have a confirmed diagnosis of fungal nail infection, those younger than 18 or older than 65 years of age, and people from vulnerable populations who cannot give proper consent or are in dependent relationships.
What the trial involves: Participants will apply the DexULac nail lacquer once daily to their affected nails for 48 weeks. Throughout the study, regular assessments will be conducted at 12, 24, 36, 48, and 52 weeks to monitor progress. The study team will use the Onychomycosis Severity Index to measure changes in nail condition and photographic images to track improvements. Additionally, participants will complete questionnaires to assess how the infection and treatment affect their daily life and self-esteem. Safety will be monitored by recording any side effects or adverse reactions throughout the treatment period.
Investigational drug: DexULac is a topical antifungal medication applied directly to the affected nails. It works by targeting the fungal cells and disrupting their growth, helping to clear the infection and improve nail appearance over time.
Study on the Safety and Effectiveness of Terbinafine Solution for Treating Mild to Moderate Nail Fungus in Children Aged 6-17 Years
This international trial is testing MOB015B, a topical solution containing terbinafine, specifically for children and adolescents with fungal toenail infections. The study is being conducted across Denmark, Iceland, Italy, and Poland, and aims to evaluate how well the treatment works in younger patients, as well as its safety profile.
Who can participate: The study is recruiting children and adolescents between 6 and 17 years old who have distal subungual onychomycosis affecting at least one big toenail. The infection must involve between 20% and 50% of the nail, with at least 3 mm of healthy nail remaining near the base. Participants must have positive laboratory tests confirming the presence of dermatophyte fungi. The child’s toenail must show evidence of growth, such as needing to be cut at least once a month. Both the child and their parent or guardian must provide written consent to participate.
Who cannot participate: Children younger than 2 years old are excluded from the study. Those without a confirmed diagnosis of distal subungual onychomycosis, individuals unable to follow study procedures, those with other medical conditions that might interfere with the study, and participants currently using other nail infection treatments cannot join. The trial also excludes anyone with allergies to the study medication, pregnant or breastfeeding individuals, and those who have recently participated in another clinical trial.
What the trial involves: Participants will apply the MOB015B solution directly to the affected toenail as directed by the study protocol. The treatment will continue for several months, with regular monitoring visits to assess progress. The study team will evaluate whether the treatment successfully reduces the infection and helps the nail return to a healthy appearance. Success is defined as having 0-10% clinical disease involvement of the treated toenail and elimination of the fungus by week 48. Safety and tolerability will be closely monitored throughout the study, which is expected to conclude by September 2026.
Investigational drug: MOB015B is a topical antifungal solution that works at the molecular level by disrupting fungal cell membranes and inhibiting fungal growth. It is applied directly to the affected nail and is being studied specifically for its effectiveness and safety in treating nail fungus in children and adolescents.
Summary
The two ongoing clinical trials for fungal nail infections reflect different approaches to treating this condition. One study focuses on adult patients in Spain using ciclopirox-based treatment, while the other takes a broader international approach across multiple European countries, specifically targeting the pediatric population with a terbinafine-based solution. Both studies emphasize topical treatment applications, which may offer convenience and potentially fewer systemic side effects compared to oral medications. The inclusion of quality of life assessments in the adult trial highlights the recognition that nail fungal infections can significantly impact daily activities and emotional well-being. The pediatric trial’s multi-country approach may help gather more diverse data and potentially speed up recruitment for this important age group that has fewer treatment options studied specifically for them.
