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

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What is this study about?

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.

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Private practice of Dr FINK Wolfram	Wavre	Belgium
Private practice of Dr Benoit Moons	Namur	Belgium
Pwaaoxi pjyzghlt of Da Sgpaevveg Mmieam	Fontaine l'Eveque	Belgium
Plqkloe prexijjn oj Dv Ctsvkgspzzetdn Skisu	Brussels	Belgium
Prpwqvc piuxdliy ou Dz Vnseni Fhubs	Gent	Belgium
Pdbffad poqxpizo on Do Blfbhxqy Nnncyjck	Saint Symphorien	Belgium
Pmtllba pxotvtda ou Ds Mmrdrvsw Kksmmhj	Seneffe	Belgium
Pobwkwz pwiqskld oy Dq Tywhha Lwcwgoga	Tubize	Belgium
Pydajnc pisyorif od Df Pmpvd Ijwcfxmh	Lantin	Belgium
Cdhythzo Sitlq Loh Brsqq	Namur	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	17.02.2020

Trial locations

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.

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.

Trial ID:

2024-514476-40-00

NCT ID:

NCT03977753

Trial Phase:

Human Pharmacology (Phase I) – Other

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?