E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Non genital warts infection |
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E.1.1.1 | Medical condition in easily understood language |
Non-genital warts (Verruca vulgaris, verruca plantaris, verruca plana) |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10035150 |
E.1.2 | Term | Planar warts |
E.1.2 | System Organ Class | 100000004864 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10035158 |
E.1.2 | Term | Plantar warts |
E.1.2 | System Organ Class | 100000004864 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10047828 |
E.1.2 | Term | Warts |
E.1.2 | System Organ Class | 100000004864 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10010115 |
E.1.2 | Term | Common warts |
E.1.2 | System Organ Class | 100000004864 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Evaluation of the efficacy of 2LVERU® JUNIOR and 2LVERU® on the treatment of warts at the end of treatment (6 month visit). |
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E.2.2 | Secondary objectives of the trial |
- Evaluate the non-inferiority efficacy of 2LVERU® JUNIOR and 2LVERU® vs cryotherapy on the treatment of warts at the end of treatment. - Evaluation of the pain related to warts and treatment in 2LVERU® JUNIOR and 2LVERU® arm vs cryotherapy arm during the study. - Evaluation of the efficacy of 2LVERU® JUNIOR and 2LVERU® on the treatment of warts at 4 months. - Evaluation according to 4 levels (total disappearance, partial disappearance (50%), no modification, increase of number of warts) of the efficacy of 2LVERU® JUNIOR and 2LVERU® vs cryotherapy on the treatment of warts at the end of treatment. - Compare the efficacy of 2LVERU® JUNIOR and 2LVERU® vs cryotherapy with regards to emergence of warts at 3-month post treatment visit. - Safety issues.
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
An ancillary study will be carried out for a sub-population of patients included in Group n°2. Patients participating in this ancillary study will have to meet the following two criteria: - fail cryotherapy according to the criteria mentioned in 6.1, - agree to participate in the ancillary study.
Objectives : - Evaluation of the efficacy of 2LVERU® JUNIOR and 2LVERU® on the treatment of warts at 4 months, after failure of cryotherapy treatment. - Evaluation of the efficacy of 2LVERU® JUNIOR and 2LVERU® on the treatment of warts at the end of treatment (6 months' visit), after failure of cryotherapy treatment.
Endpoints: - Numbers of warts disappeared at 4 months' visit in 2LVERU® JUNIOR or 2LVERU®. - Disappearance of warts at the end of treatment visit (6 months' visit) in the 2LVERU® JUNIOR or 2LVERU®.
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E.3 | Principal 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 with at least one wart eligible for cryotherapy, - 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).
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E.4 | Principal 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 curatorship, (*) important renal or respiratory insufficiency, transplanted or grafted patients, HIV/AIDS, terminal cancer.
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E.5 End points |
E.5.1 | Primary end point(s) |
Disappearance of warts at the end of treatment visit (6 months' visit) in the 2LVERU® JUNIOR or 2LVERU®. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
- Disappearance of warts at the end of treatment visit. - Pain evaluation during the study by VAS and consumption of antalgic medication. - Numbers of warts disappeared at 4-month visit. - Disappearance level (total disappearance, partial disappearance (50%), no modification, increase of number of warts) at the end of treatment. - Warts recurrence at 3-month visit post-treatment - Safety: occurence of adverse events (AEs) and severe adverse events (SAEs), considered as related or not to the study drug.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
- End of 2LVERU® JUNIOR or 2LVERU® treatment and end of cryotherapy treatment. - Until 6 months, - 4 months, - End of 2LVERU® JUNIOR or 2LVERU® treatment (6 months) and end of cryotherapy treatment, - 3 months' visit post treatment, - Until 6 months. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Cryotherapy-controlled (treatment not supplied by the sponsor) |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 14 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 11 |