Clinical trial NCT03977753: Randomized, Placebo-controlled, Double Blind Study to Evaluate the Efficacy of 2LVERU®JUNIOR and 2LVERU® on the Treatment of Warts
Official title: Study to Evaluate the Efficacy of 2LVERU® JUNIOR and 2LVERU® on the Treatment of Warts.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Common Wart
Flat Wart
Plantar Wart
Lead sponsor: Labo'Life
Sponsor class: INDUSTRY
First posted: 2019-06-06
Enrollment: 162
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients, male or female, aged 3 years and older,
* Patients with common warts (Verruca vulgaris), and/or plantar warts (Verruca plantaris), and/or flat warts (Verruca plana),
* Patients (and/or parents if necessary) having the faculties to understand and respect the constraints of the study,
* Signature of the Informed Consent Form by the patient (and/or parents if necessary).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Disappearance of warts at the end of treatment (6-month visit)
timeFrame: 6 months
Secondary outcomes:
measure: Disappearance of warts at 4 months.
timeFrame: 4 months
measure: Disappearance level (total disappearance, partial disappearance (50%), no modification, increase of number of warts) at 4 months
timeFrame: 4 months
measure: Warts recurrence at 9 months
timeFrame: 9 months
measure: Pain evaluation during the study by visual analogic scale and consumption of antalgic medication.
timeFrame: 6 months
measure: Safety: occurence of adverse events (AEs) and severe adverse events (SAEs), considered as related or not to the study drug.
timeFrame: 6 months
measure: Disappearance level (total disappearance, partial disappearance (50%), no modification, increase of number of warts) at 6 months
timeFrame: 6 months
Other outcomes:
Locations:
city: Arlon
country: Belgium
facility: Private Practice
city: Bouge
country: Belgium
facility: Clinique Saint-Luc (Bouge)
city: Brussel
country: Belgium
facility: Private Practice
city: Ecaussinnes-d'enghien
country: Belgium
facility: Private Practice
city: Fontaine l'Êveque
country: Belgium
facility: Private Practice
city: Gent
country: Belgium
facility: Private Practice
city: Gozée
country: Belgium
facility: Private Practice
city: Hamme-Mille
country: Belgium
facility: Private Practice
city: Juprelle
country: Belgium
facility: Private Practice
city: Mons
country: Belgium
facility: Private Practice
city: Namur
country: Belgium
facility: Private Practice
city: Namur
country: Belgium
facility: Private Practice
city: Oisquercq
country: Belgium
facility: Private Practice
city: Plancenoit
country: Belgium
facility: Private Practice
city: Quiévrain
country: Belgium
facility: Private Practice
city: Saint-Symphorien
country: Belgium
facility: Private Practice
city: Seneffe
country: Belgium
facility: Private Practice
city: Wavre
country: Belgium
facility: Private Practice
Study officials:
References: