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Study on the Effect of Ciclopirox in Treating Nail Fungal Infection in Patients

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on studying the effects of a treatment for onychomycosis, which is a fungal infection of the nails. The treatment being tested is called DexULac, a medicated nail lacquer containing the active substance ciclopirox. The purpose of the study is to observe how this treatment affects the severity of the nail infection and the quality of life of those affected.

Participants in the study will apply the DexULac nail lacquer to the affected nails over a period of 48 weeks. Throughout the study, the progress of the nail infection will be monitored at various intervals to see how the condition changes over time. Additionally, the study will assess how the treatment impacts the participants' quality of life, as living with nail infections can sometimes affect daily activities and self-esteem.

The study will also evaluate the safety of the treatment by keeping track of any side effects or adverse reactions that may occur during the 48-week treatment period. The goal is to determine not only the effectiveness of DexULac in treating onychomycosis but also to ensure that it is safe for use by patients. Participants will be regularly checked to ensure their well-being and to gather data on the treatment's impact on their nail health and overall quality of life.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, informed consent is required. This means understanding the study details and agreeing to participate.
Eligibility is confirmed for adults aged 18 to 75 with mild to moderate nail fungal infection, affecting 10% to 40% of the nail.
Step 2
Initial assessment
An initial assessment is conducted to evaluate the severity of the nail condition using the Onychomycosis Severity Index (OSI).
A Dermatology Life Quality Index (DLQI) questionnaire is completed to assess the impact on quality of life.
Step 3
Treatment phase
The treatment involves applying DexULac, a medicated nail lacquer containing ciclopirox, topically to the affected nails.
The lacquer is applied once daily for a period of 48 weeks.
Step 4
Follow-up visits
Follow-up visits occur at 12, 24, 36, 48, and 52 weeks to monitor progress.
During these visits, the severity of the nail condition is reassessed using the OSI, and the DLQI questionnaire is repeated.
Step 5
Evaluation of clinical success
Clinical success is evaluated by a decrease in the affected nail area to less than 10% of the total nail area.
Photographic images are used to assess changes in the nail condition.
Step 6
Safety monitoring
The safety of the treatment is monitored by recording any adverse events or reactions throughout the 48-week treatment period.
The severity and cause of each event are evaluated.
Step 7
Final assessment
A final assessment is conducted within 4 weeks after the last treatment visit to evaluate the overall outcome.
A PCR test is performed to check for the presence of fungi causing the infection.

Who can join the trial?

5 criteria

Provide informed consent before starting any procedure related to the study. This means you agree to participate after understanding the study details.
Be an adult man or woman aged between 18 and 75 years at the time of joining the study.
Have been diagnosed with mild to moderate distal onychomycosis due to dermatophyte fungi. This means a fungal infection affecting the nails, with nail involvement between 10% and 40% at the time of joining the study.
Have been diagnosed with onychomycosis in the last 6 months.
Women who can have children must have a negative urine pregnancy test and agree to use effective birth control from 14 days before the first dose until 4 weeks after the last dose of the study medication. This applies to women from the start of menstruation to postmenopause, unless they have had surgery to remove the uterus, fallopian tubes, and ovaries.

Who cannot join the trial?

3 criteria

Patients who are not diagnosed with onychomycosis cannot participate. Onychomycosis is a fungal infection of the nails.
Patients who are younger than 18 years old or older than 65 years old cannot participate.
Patients who are part of vulnerable populations, such as those who cannot give consent or are in a dependent relationship, cannot participate.

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Verified
Clínica DYN Sant Andreu
Barcelona, Spain

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Investigated drugs

DexULac® is a treatment used in this clinical trial to help people with onychomycosis, which is a fungal infection of the nails. The goal of using DexULac® is to see how it affects the severity of the infection and the quality of life of the patients over a period of 48 weeks. This medication is applied to the affected nails and works by targeting the fungus causing the infection, helping to improve the condition of the nails and reduce symptoms associated with the infection.

CICLOPIROX

What is already known about the treatment

DexULac® – DexULac® is administered topically, meaning it is applied directly to the affected area, specifically the nails, to treat onychomycosis, a fungal infection of the nails. Currently, it is being studied in a Phase IV clinical trial to assess its effectiveness in improving the severity of onychomycosis and enhancing the quality of life for patients over a 48-week period. The medication works by targeting the fungal cells, disrupting their growth and reproduction at the molecular level, which helps clear the infection. DexULac® is classified as an antifungal agent, designed to combat fungal infections effectively.

Investigated diseases

Onychomycosis – Onychomycosis is a fungal infection that affects the nails, commonly the toenails. It begins with a small white or yellow spot under the tip of the nail and can progress to cause the nail to discolor, thicken, and crumble at the edges. As the infection advances, the nail may become distorted in shape and develop a foul odor. The affected nail can become painful and may separate from the nail bed. The condition can spread to other nails and surrounding skin if not managed. It is more common in older adults and those with certain health conditions, such as diabetes or a weakened immune system.