Recruiting

Study on the Effectiveness of Interferon Alfa, Interleukin-1, and Interleukin-2 in Treating Non-Genital Warts in Patients

Registered 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 is focused on studying the treatment of warts, which are small, non-cancerous growths on the skin caused by a virus. The study will evaluate the effectiveness of two treatments, 2LVERU JUNIOR and 2LVERU, in comparison to a placebo. These treatments contain a combination of substances, including interferon alfa, interleukin-1, interleukin-2, ribonucleic acid, and specific nucleic acids known as SNA-HLA II and SNA-VERU. These substances are designed to help the body fight off the virus that causes warts.

The purpose of the study is to compare how well these treatments work in making warts disappear by the end of the treatment period, which lasts for six months. Participants in the study will be randomly assigned to receive either the 2LVERU treatments or a placebo. The study is conducted in a double-blind manner, meaning neither the participants nor the researchers know who is receiving the actual treatment or the placebo, to ensure unbiased results.

Throughout the study, participants will have regular check-ups to monitor the disappearance of warts and any potential side effects. The study will also assess the level of pain experienced and the use of pain relief medication. The main goal is to see if the warts disappear completely or partially, and to check if they come back after the treatment ends. Safety will be closely monitored by tracking any adverse events that may occur during the study.

The research process

The trial runs in 6 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, the patient is required to sign an informed consent form. This form confirms understanding and agreement to participate in the study.
Step 2
Initial assessment
An initial assessment is conducted to confirm eligibility. This includes verifying the presence of common, plantar, or flat warts and ensuring the patient is aged 3 years or older.
Step 3
Treatment administration
The patient receives either 2LVERU or 2LVERU JUNIOR granules or a placebo. The granules are administered through oromucosal use, which means they are taken by mouth and absorbed through the mucous membranes.
The treatment is administered over a period of 6 months.
Step 4
Follow-up visits
Regular follow-up visits are scheduled to monitor the progress of the treatment. These visits occur at 4 months and 6 months after the start of the treatment.
During these visits, the disappearance of warts is evaluated, and any side effects or adverse events are recorded.
Step 5
End of treatment evaluation
At the end of the 6-month treatment period, a final evaluation is conducted to assess the disappearance of warts.
The primary goal is to determine if the warts have disappeared completely.
Step 6
Post-treatment follow-up
A follow-up visit is scheduled 3 months after the end of the treatment to check for any recurrence of warts.
Pain levels and the use of pain relief medication are also evaluated during this period.

Who can join the trial?

5 criteria

Patients must be **3 years old or older**.
Patients can be **male or female**.
Patients must have **common warts** (also known as Verruca vulgaris), **plantar warts** (also known as Verruca plantaris), or **flat warts** (also known as Verruca plana).
Patients, or their parents if needed, must be able to **understand and follow the study requirements**.
Patients, or their parents if needed, must **sign the Informed Consent Form**, which is a document that explains the study and confirms their agreement to participate.

Who cannot join the trial?

1 criterion

Individuals with a **non-genital warts infection** cannot participate. This means if you have warts that are not located in the genital area, you are not eligible for the study.

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Investigated drugs

2LVERU® JUNIOR
is a treatment being studied for its effectiveness in removing warts. It is designed specifically for younger patients and aims to help clear warts over a period of six months. The study is comparing how well this treatment works compared to not using any active treatment.
2LVERU®
is another treatment being tested in the study for its ability to eliminate warts. This version is intended for a broader range of patients and is also evaluated over a six-month period. The goal is to see if it can effectively reduce or remove warts compared to not using any active treatment.

What is already known about the treatment

2LVERU® – This medication is administered topically, applied directly to the skin where warts are present. It is currently being studied in clinical trials to assess its effectiveness in treating non-genital warts. The main therapeutic indication is the removal of warts, aiming to reduce or eliminate them over a treatment period. The mechanism of action involves targeting the wart tissue to promote its breakdown and removal. It is classified pharmacologically as a topical treatment for skin conditions.

Investigated diseases

Non-genital warts infection – Non-genital warts are small, rough growths on the skin caused by certain types of the human papillomavirus (HPV). They are commonly found on the hands, fingers, and feet, and are more prevalent in children and young adults. These warts are contagious and can spread through direct contact with the wart or indirectly through surfaces. Over time, they may grow in size or number, but they often remain harmless and painless. In some cases, they may cause discomfort or irritation, especially if located in areas subject to pressure or friction. The body's immune system can eventually clear the virus, leading to the disappearance of the warts.