Plantar Wart Clinical Trial
— EVAsIONOfficial title:
Study to Evaluate the Efficacy of 2LVERU® JUNIOR and 2LVERU® on the Treatment of Warts.
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.
Status | Recruiting |
Enrollment | 162 |
Est. completion date | March 16, 2024 |
Est. primary completion date | December 16, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Belgium | Private Practice | Arlon | |
Belgium | Clinique Saint-Luc (Bouge) | Bouge | |
Belgium | Private Practice | Brussel | |
Belgium | Private Practice | Ecaussinnes-d'enghien | |
Belgium | Private Practice | Fontaine l'Êveque | |
Belgium | Private Practice | Gent | |
Belgium | Private Practice | Gozée | |
Belgium | Private Practice | Hamme-Mille | |
Belgium | Private Practice | Juprelle | |
Belgium | Private Practice | Mons | |
Belgium | Private Practice | Namur | |
Belgium | Private Practice | Namur | |
Belgium | Private Practice | Oisquercq | |
Belgium | Private Practice | Plancenoit | |
Belgium | Private Practice | Quiévrain | |
Belgium | Private Practice | Saint-Symphorien | |
Belgium | Private Practice | Seneffe | |
Belgium | Private Practice | Wavre |
Lead Sponsor | Collaborator |
---|---|
Labo'Life |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 6 months | |
Secondary | Disappearance of warts at 4 months. | 4 months | ||
Secondary | Disappearance level (total disappearance, partial disappearance (50%), no modification, increase of number of warts) at 4 months | 4 months | ||
Secondary | Warts recurrence at 9 months | 9 months | ||
Secondary | Pain evaluation during the study by visual analogic scale and consumption of antalgic medication. | Minimum value: 0 (better outcome) Maximum Value: 10 (worse outcome) | 6 months | |
Secondary | Safety: occurence of adverse events (AEs) and severe adverse events (SAEs), considered as related or not to the study drug. | 6 months | ||
Secondary | Disappearance level (total disappearance, partial disappearance (50%), no modification, increase of number of warts) at 6 months | 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05324904 -
Intralesional Vitamin D3 Versus Intralesional Acyclovir in Treatment of Plantar Warts
|
N/A | |
Completed |
NCT00328991 -
Clinical Trial Evaluating Efficacy of Duct Tape for Treatment of Warts
|
N/A | |
Completed |
NCT05592041 -
Studying of Natural Constituents' Treatment of Plantar Warts
|
Early Phase 1 | |
Completed |
NCT05115669 -
Safety & Effectiveness of Wortie Freeze Plus in Common and Plantar Warts
|
N/A | |
Recruiting |
NCT06261684 -
Intralesional Acyclovir Versus Cryotherapy in the Treatment of Plantar Warts. A Randomized Controlled Trial.
|
Phase 2/Phase 3 | |
Not yet recruiting |
NCT05057663 -
Intralesional Treatment of Plantar Wart
|
N/A | |
Recruiting |
NCT02151630 -
Pyruvic Acid Versus Salicylic Acid Preparation in Treatment of Plantar Warts
|
Phase 2/Phase 3 | |
Withdrawn |
NCT04823845 -
Plantar Wart Treatment Using Adapalene Gel
|
Early Phase 1 | |
Completed |
NCT05588999 -
Comparative Study Between Treatment With Cryotherapy Alone Versus Cryotherapy Plus Salicylic Acid Dressing for Planter Warts
|
Phase 1 | |
Completed |
NCT01536834 -
Safety & Performance Study of Verruca Treatment Device
|
N/A | |
Recruiting |
NCT05488860 -
Piezoelectric Drived Microneedling in Treating Refractory Skin Diseases
|
N/A | |
Recruiting |
NCT05520658 -
Evaluation of the Efficacy of Intralesional Injection of Combined Digoxin and Furosemide Versus 5 - Fluorouracil in Treatment of Plantar Warts
|
N/A | |
Not yet recruiting |
NCT04654091 -
Cryotherapy VS. Nitric-zinc Complex in the Treatment of Plantar Warts.
|
N/A | |
Not yet recruiting |
NCT05599971 -
Intralesional Injection of Combined Digoxin and Furosemide Versus 5-Flurouracil in Plantar Warts
|
N/A | |
Not yet recruiting |
NCT05198180 -
Treatment of Plantar Warts
|
Phase 3 | |
Recruiting |
NCT06214559 -
Evaluate the Effectiveness and the Safety of a Medical Device in the Treatment of Common Warts and Plantar Warts.
|
N/A | |
Completed |
NCT03183765 -
Intralesional Measles, Mumps, Rubella (MMR) Vaccine Versus Cryotherapy in Treatment of Multiple Common and Planter Warts
|
Phase 4 |