E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Verrucae vulgares or common warts are benign epithelial tumors of the skin caused by infection with human papilloma viruses (HPV). Due to immunosuppression organ transplant recipients are at high risk for developing viral infections such as HPV-induced warts. The incidence varies from 24-53% depending on the level of their immunosuppressive therapy. |
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MedDRA Classification |
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 |
The aim of this study is to assess the response of persistent cutaneous warts to Verrumal® solution in immunosuppressed individuals (OTR).
Primary variable is the response to treatment assessed by clinical scoring.
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E.2.2 | Secondary objectives of the trial |
Secondary endpoints will be the evaluation of lesion size; overall improvement / efficacy assessed by investigator and by patient, safety laboratory controls at baseline, week 4 and 8 (creatinine, blood-electrolytes, renal and hepatic values); the evaluation of adverse events and the assessment of local skin reactions at each visit, overall tolerability as rated by investigator and by patient. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
· Given written informed consent · Men or women aged 18 or over · Diagnosis of verrucae vulgaris with a minimum duration of 3 months · Organ transplant recipients for a minimum of 2 years · Women are required to use a reliable method of contraception or are postmenopausal · Existence of a minimum of 5 warts – located on hands and forearms · Patient is willing and able to participate in the study as an outpatient, make frequent visits to the clinic, and comply with all study requirements, including the following: o clinic visits during the prestudy, treatment, and follow-up period o application of study medication (Verrumal® solution, placebo solution) o pre-treatment curettage for virus typing, blood sample and eyebrow hairs o post-treatment curettage for virus typing o pregnancy testing for females of childbearing potential
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E.4 | Principal exclusion criteria |
· Known allergic or hypersensitive reactions to components of the study medication · Diagnosis of subungual or periungal warts in the treatment area, · Warts treatment within the previous 3 months before inclusion · Area to be treated exceeds 25 cm² · Patient is taking any medication which could interfere with the study drug and could influence interactions; e.g Methotraxate, Sulfonylurea, Salicylic acid, Dihydropyrimidindehydrogenase-(DPDH)-Inhibitor, Brivudin, systemic 5-FU
· Renal failure (creatinine > 6mg/dl) · Serious illness within the previous 4 weeks or life-threatining diseases · Pregnancy or nursing (lactation) · Participation in another clinical trial in the month preceding the study · Patient has a severe illness or psychiatric condition on account of which the patient should not participate in the study in the opinion of the investigator
· Patient is suffering from active chemical dependency or alcoholism, as assessed by the investigator.
· Maximum of 10 warts in the treatment area
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary variable is the response to treatment assessed by clinical scoring |
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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 | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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 | Information not present in EudraCT |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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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Criteria for discontinuing the whole study
· Serious drug-related concomitant symptoms in two or more patients · Serious, previously unknown adverse effects · Information that is expected to be gathered by this trial has already been gained by other means.
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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 | 2 |
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 | 2 |