Randomized, Placebo-controlled, Double Blind Study to Evaluate the Efficacy of 2LVERU®JUNIOR and 2LVERU® on the Treatment of Warts

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-17

Study Completion Date

2027-03-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Human papillomavirus (HPV) infection is very common, as most people will experience infection during their lifetime. The most common manifestation of HPV infection is common warts. Common warts may appear at any age.

Conventional treatments can be used to treat warts and they are based on two mechanisms: stimulation of cellular immunity against HPVs or destruction of the lesion. These treatments are based on the location of the wart and the degree of the symptoms.

No specific antiviral therapy is available to cure warts and today, there is no treatment that allows the definitive eradication of the virus.

The 2LVERU® has been available for more than 20 years, and has received a marketing authorization in Belgium by the Federal Agency for Medicines and Health Products (FAMHP). It is used as an immune regulator in the treatment of common warts (verruca vulgaris), flat warts (verruca plana) or plantar warts (verruca plantaris) caused by Human Papillomavirus. Since 2LVERU® has been made available, clinical observational data collected on treated patients have shown the beneficial effect on the disappearance of warts.

The purpose of this placebo-controlled, randomized, double-blind trial is the comparison of the efficacy of the treatment on the disappearance of warts at the end of treatment (6-month visit) between the 2LVERU® JUNIOR and 2LVERU® versus the placebo group.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Efficacy of Intra-lesional Bleomycin Versus Intra-lesional Purified Protein Derivative in Treatment of Palmoplantar Warts

NCT03477448

Warts

UNKNOWN PHASE4

Topical 2% Povidone-Iodine Gel in Verruca Vulgaris

NCT04253912

Warts

UNKNOWN PHASE2

A Placebo-Controlled Study Using VP-102 in the Treatment of External Genital Warts

NCT03981822

Condylomata Acuminata Papillomavirus Infections Skin Diseases, Viral +5 more

COMPLETED PHASE2

A Phase 2 Efficacy Study of CLS003 ICVT in Subjects With Cutaneous Warts.

NCT02333643

Cutaneous Warts

COMPLETED PHASE2

A Study to Assess the Efficacy of Omnivirol-Salicylic Acid Combination Therapy for Cutaneous Warts With Emphasis on Persistent Warts

NCT05862441

Cutaneous Warts

COMPLETED PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study duration will be maximum 45 months with 36 months of inclusion and 9 months of follow-up.

Patients aged 3 years and older who present common warts (Verruca vulgaris), and/or plantar warts (Verruca plantaris), and/or flat warts (Verruca plana) during a visit with their dermatologist/general practitioner.

The total number of patients to include will be 162.

Primary objective:

Comparison of the efficacy of the treatment on the disappearance of warts at the end of treatment (6-month visit) between the 2LVERU® JUNIOR and 2LVERU® versus the placebo group.

Secondary objectives

* Comparison of the efficacy of the treatment on the disappearance of warts at 4 months between groups.
* Comparison of the efficacy of the treatment on the level of disappearance (4 levels) of warts at 4 months and 6 months (end of the treatment) between groups
* Comparison of the efficacy of the treatment on the recurrence of warts 3 months after the end of treatment between groups
* Compare the pain related to warts during the study between groups
* Safety issues.

Treatment phase:

* Group n°1 = 2LVERU® JUNIOR / 2LVERU® (6 months of treatment)
* Group n°2 = Placebo (6 months of treatment)

Post-treatment Follow-up phase: 3 months

Treatment will be considered successful if the following three criteria are met for all treated warts as described at the baseline visit:

* Normal skin colour at the wart site
* Normal skin texture at the wart site
* Normal touch at the wart site Treatment will be considered a failure, at the end of the treatment, if at least one of the above three criteria is not met for all treated warts as described at the baseline visit.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Common Wart Flat Wart Plantar Wart

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Double-blind study

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

2LVERU®/2LVERU® JUNIOR

Group N°1: 2LVERU® or 2LVERU® JUNIOR treatment (6 months of treatment)

Group Type EXPERIMENTAL

2LVERU® or 2LVERU® JUNIOR

Intervention Type DRUG

The treatment schema consists in taking the content of one capsule a day, 15-30 minutes before breakfast, on an empty stomach, sequentially, according to capsules' numerical order: 1 through 10. When capsule number 10 is taken, capsule 1 of the next blister should be taken on the next day to continue the treatment.

The duration of treatment will be 6 months of continuous intake of the content of 1 capsule/day.

Placebo

Group N°2: Placebo treatment (6 months of treatment)

Group Type PLACEBO_COMPARATOR

Placebo

* Patients who have received any curative warts treatment in the previous 2 months prior to the study,
* Patients who have received any homeopathic treatment in the previous 2 months prior to the study,
* Patients under immunosuppressive treatment,
* Patients having received immunotherapy or micro-immunotherapy during the last 6 months,
* Patients with known lactose intolerance,
* Pregnant or breastfeeding women,
* Patients who participated in a clinical study in the previous 2-months period,
* Patients (and/or parents of patients if necessary) who are not sufficiently motivated to engage on the total study follow-up period, or likely to travel or to move before the end of the study,
* Patients with severe immunodeficiency disease requiring long term treatment (\*) or patients under chemotherapy or radiotherapy,
* Patients under listed homeopathic or phytotherapy treatment (see protocol),
* Patients addicted to or using recreational drugs,
* Patient under guardianship and/or curators, (\*) important renal or respiratory insufficiency, transplanted or grafted patients, HIV/AIDS, terminal cancer.

Minimum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No