Randomized, Placebo-controlled, Double Blind Study to Evaluate the Efficacy of 2LVERU®JUNIOR and 2LVERU® on the Treatment of Warts (EVAsION)
Primary Purpose
Common Wart, Flat Wart, Plantar Wart
Status
Recruiting
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
2LVERU® or 2LVERU® JUNIOR
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Common Wart
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.
Sites / Locations
- Private Practice
- Clinique Saint-Luc (Bouge)Recruiting
- Private Practice
- Private Practice
- Private Practice
- Private PracticeRecruiting
- Private Practice
- Private PracticeRecruiting
- Private Practice
- Private Practice
- Private PracticeRecruiting
- Private Practice
- Private Practice
- Private Practice
- Private Practice
- Private PracticeRecruiting
- Private PracticeRecruiting
- Private PracticeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
2LVERU®/2LVERU® JUNIOR
Placebo
Arm Description
Group N°1: 2LVERU® or 2LVERU® JUNIOR treatment (6 months of treatment)
Group N°2: Placebo treatment (6 months of treatment)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Disappearance of warts at 4 months.
Disappearance level (total disappearance, partial disappearance (50%), no modification, increase of number of warts) at 4 months
Warts recurrence at 9 months
Pain evaluation during the study by visual analogic scale and consumption of antalgic medication.
Minimum value: 0 (better outcome) Maximum Value: 10 (worse outcome)
Safety: occurence of adverse events (AEs) and severe adverse events (SAEs), considered as related or not to the study drug.
Disappearance level (total disappearance, partial disappearance (50%), no modification, increase of number of warts) at 6 months
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03977753
Brief Title
Randomized, Placebo-controlled, Double Blind Study to Evaluate the Efficacy of 2LVERU®JUNIOR and 2LVERU® on the Treatment of Warts
Acronym
EVAsION
Official Title
Study to Evaluate the Efficacy of 2LVERU® JUNIOR and 2LVERU® on the Treatment of Warts.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 17, 2020 (Actual)
Primary Completion Date
December 16, 2023 (Anticipated)
Study Completion Date
March 16, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Labo'Life
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Wart, Flat Wart, Plantar Wart
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Double-blind study
Allocation
Randomized
Enrollment
162 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
2LVERU®/2LVERU® JUNIOR
Arm Type
Experimental
Arm Description
Group N°1: 2LVERU® or 2LVERU® JUNIOR treatment (6 months of treatment)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Group N°2: Placebo treatment (6 months of treatment)
Intervention Type
Drug
Intervention Name(s)
2LVERU® or 2LVERU® JUNIOR
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Disappearance of warts at the end of treatment (6-month visit)
Description
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 months
Secondary Outcome Measure Information:
Title
Disappearance of warts at 4 months.
Time Frame
4 months
Title
Disappearance level (total disappearance, partial disappearance (50%), no modification, increase of number of warts) at 4 months
Time Frame
4 months
Title
Warts recurrence at 9 months
Time Frame
9 months
Title
Pain evaluation during the study by visual analogic scale and consumption of antalgic medication.
Description
Minimum value: 0 (better outcome) Maximum Value: 10 (worse outcome)
Time Frame
6 months
Title
Safety: occurence of adverse events (AEs) and severe adverse events (SAEs), considered as related or not to the study drug.
Time Frame
6 months
Title
Disappearance level (total disappearance, partial disappearance (50%), no modification, increase of number of warts) at 6 months
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charlotte Bolle
Phone
(0)497 49 13 74
Ext
+32
Email
charlotte.bolle@labolife.com
First Name & Middle Initial & Last Name or Official Title & Degree
Laura FERTE
Phone
(0)499 71 79 64
Ext
+32
Email
laura.ferte@labolife.com
Facility Information:
Facility Name
Private Practice
City
Arlon
ZIP/Postal Code
6700
Country
Belgium
Individual Site Status
Withdrawn
Facility Name
Clinique Saint-Luc (Bouge)
City
Bouge
ZIP/Postal Code
5004
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Audrey SCHILS, Dr
First Name & Middle Initial & Last Name & Degree
Audrey SCHILS, Dr
Facility Name
Private Practice
City
Brussel
ZIP/Postal Code
1020
Country
Belgium
Individual Site Status
Terminated
Facility Name
Private Practice
City
Ecaussinnes-d'enghien
ZIP/Postal Code
7190
Country
Belgium
Individual Site Status
Terminated
Facility Name
Private Practice
City
Fontaine l'Êveque
ZIP/Postal Code
6140
Country
Belgium
Individual Site Status
Suspended
Facility Name
Private Practice
City
Gent
ZIP/Postal Code
9942
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Filip Dr Verrue
First Name & Middle Initial & Last Name & Degree
Filip Dr Verrue
Facility Name
Private Practice
City
Gozée
ZIP/Postal Code
6534
Country
Belgium
Individual Site Status
Terminated
Facility Name
Private Practice
City
Hamme-Mille
ZIP/Postal Code
1320
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susanne Dr Hausdorfer
First Name & Middle Initial & Last Name & Degree
Susanne Dr Hausdorfer
Facility Name
Private Practice
City
Juprelle
ZIP/Postal Code
4450
Country
Belgium
Individual Site Status
Withdrawn
Facility Name
Private Practice
City
Mons
ZIP/Postal Code
7000
Country
Belgium
Individual Site Status
Withdrawn
Facility Name
Private Practice
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernadette BLOUARD, Dr
First Name & Middle Initial & Last Name & Degree
Bernadette BLOUARD, Dr
Facility Name
Private Practice
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Individual Site Status
Withdrawn
Facility Name
Private Practice
City
Oisquercq
ZIP/Postal Code
1480
Country
Belgium
Individual Site Status
Terminated
Facility Name
Private Practice
City
Plancenoit
ZIP/Postal Code
1380
Country
Belgium
Individual Site Status
Withdrawn
Facility Name
Private Practice
City
Quiévrain
ZIP/Postal Code
7380
Country
Belgium
Individual Site Status
Withdrawn
Facility Name
Private Practice
City
Saint-Symphorien
ZIP/Postal Code
7030
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathalie BEAUCHOT, Dr
First Name & Middle Initial & Last Name & Degree
Nathalie BEAUCHOT, Dr
Facility Name
Private Practice
City
Seneffe
ZIP/Postal Code
7180
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristel MESTDAGH, Dr
First Name & Middle Initial & Last Name & Degree
Kristel MESTDAGH, Dr
Facility Name
Private Practice
City
Wavre
ZIP/Postal Code
1300
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wolfram FINK, Dr
First Name & Middle Initial & Last Name & Degree
Wolfram Fink, Dr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Randomized, Placebo-controlled, Double Blind Study to Evaluate the Efficacy of 2LVERU®JUNIOR and 2LVERU® on the Treatment of Warts
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