Randomized, Placebo-controlled, Double Blind Study to Evaluate the Efficacy of 2LVERU®JUNIOR and 2LVERU® on the Treatment of Warts
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age3+
SponsorLabo'Life
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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,
Trial design
Design model
Parallel
Treatments tested in this trial
2LVERU® or 2LVERU® JUNIOR
DrugThe 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
DrugThe 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.
Treatment groups
162 Participants
are divided into 2 treatment groupsGroup A: 2LVERU®/2LVERU® JUNIORExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Disappearance of warts at the end of treatment (6-month visit)
A wart will be considered as disappeared if the colour and texture of the skin has returned to normal and can no longer be felt to the touch.
Time frame
6 monthsSecondary outcomes
1
Disappearance of warts at 4 months.
Time frame
4 months2
Disappearance level (total disappearance, partial disappearance (50%), no modification, increase of number of warts) at 4 months
Time frame
4 months3
Warts recurrence at 9 months
Time frame
9 months4
Pain evaluation during the study by visual analogic scale and consumption of antalgic medication.
Minimum value: 0 (better outcome) Maximum Value: 10 (worse outcome)
Time frame
6 months Source ClinicalTrials.gov