E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 |
To compare the clinical effectiveness of cryotherapy versus salicylic acid for the treatment of verrucae in terms of the complete clearance of all verrucae as observed on digital photographs taken at baseline and 12 weeks and assessed by an independent health care professional (eg podiatrist, GP, practice nurse). Blinded health care professional assessment will be used if for some reason the digital photograph is not interpretable. ‘Clearance’ of verrucae will be defined as being the restoration of normal skin upon close inspection, as assessed by the health care professional. |
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E.2.2 | Secondary objectives of the trial |
To compare the cost effectiveness of cryotherapy versus salicylic acid for the treatment of verrucae in terms of the complete clearance of all verrucae. To assess the acceptability of the two approaches and to investigate: - Self-reported time to clearance of verrucae - Recurrence/clearance of verrucae at six months
In addition to this, side effects of treatment, pain intensity after treatment, use of painkillers, restrictions to lifestyle due to having the verruca, and treatment details will be recorded. Patient satisfaction with the treatment and the number of verrucae will also be recorded.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients will be eligible if all of the following criteria apply:
The patient has a verruca that in the opinion of the health care professional is suitable for treatment with both salicylic acid and cryotherapy.
Patients are aged 12 years and over.
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E.4 | Principal exclusion criteria |
Patients will be excluded if any of the following criteria apply: • Are currently in a trial evaluating other treatments for their verruca • Have impaired healing eg due to diabetes, peripheral vascular disease or any other condition which means the patient has impaired healing • Patients that are immunosuppressed eg have agammaglobulinaemia, or are currently taking immunosuppressant drugs such as oral corticosteroids • Are unable to give informed consent • Are currently on renal dialysis Have cold intolerance eg Raynaud's syndrome or cold urticaria • Have any of the following conditions - blood dyscrasias of unknown origin, cryoglobulinaemia, cryofibrinogenaemia, collagen and auto-immune disease • Patients with neuropathy
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome will be complete clearance of all verrucae as observed on digital photographs taken at baseline and 12 weeks and assessed by an independent health care professional. Blinded health care professional assessment will also be assessed and will be used if for some reason the digital photograph is not interpretable. ‘Clearance’ of verrucae will be defined as being the restoration of normal skin upon close inspection, as assessed by the health care professional. |
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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 | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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) | Yes |
E.8.2.2 | Placebo | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 15 |
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 | Yes |
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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One month after the last patient has been sent their 6 month questionnaire. Although the patient's last visit to the clinic is at 12 weeks after randomisation, follow-up data on the recurrence of verrucae are collected by patient questionnaire 6 months post randomisation. The end of the trial is being set at one month after this time point in order to allow the questionnaire, and reminder if required, to be sent out and returned by the patient to the York Trials Unit, Univerisy of York, UK. |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |