| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN18994246 |
| Date ISRCTN assigned | 08/12/2006 |
| Local reference number(s) | HTA 05/513/02 |
| Public title | Cryotherapy versus salicylic acid for the treatment of verrucae: A randomised controlled trial. |
| Scientific title |
|
| Acronym | EVERT (Effective Verruca Treatments) |
| Disease/condition/study domain | Verrucae (plantar warts) |
| Study hypothesis | The primary objective is to compare the clinical effectiveness of cryotherapy versus salicylic acid for the treatment of verrucae. To do this, we will test the hypothesis that patients receiving cryotherapy using liquid nitrogen delivered by the health care professional will have better 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 (e.g. podiatrist, GP, practice nurse) compared to patients self-treating with 50% salicylic acid (Verrugon). |
| Design/methodology | A pragmatic, multicentre, two-arm, randomised controlled trial. |
| Research ethics review | UK MREC approval date: 26/10/2004. MREC reference: 04/MRE04/59. |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Patients aged 12 years and over
2. With a verruca that in the opinion of the health care professional is suitable for treatment with either salicylic acid or cryotherapy |
| Participants - exclusion criteria | 1. Patients are currently in a trial evaluating other treatments for their verruca
2. They have impaired healing e.g. due to diabetes, peripheral vascular disease or any other condition which means the patient has impaired healing
3. They are immunosuppressed, e.g. have agammaglobulinaemia, or are currently taking immunosuppressant drugs such as corticosteroids
4. They are unable to give informed consent
5. They are currently on renal dialysis
6. They have cold intolerance e.g. Raynaud's syndrome or cold urticaria
7. They have any of the following conditions: blood dyscrasias of unknown origin, cryoglobulinaemia, cryofibrinogenaemia, collagen and auto-immune disease |
| Patient information material |
|
| Anticipated start date | 01/10/2006 |
| Anticipated end date | 31/12/2008 |
| Status of trial | Ongoing |
| Target number of participants | 266 |
| Interventions | Please note that, as of 11 January 2008, the anticipated end date of this trial has been updated from 1 January 2009 to 31 December 2008.
Interventions:
Patients will be randomised equally between the two arms: daily self-treatment by the patient with 50% salicylic acid (Verrugon) or cryotherapy using liquid nitrogen delivered by the health care professional.
Participants will be randomised to either daily self-treatment by the patient with 50% salicylic acid (Verrugon) for a maximum of 8 weeks or cryotherapy using liquid nitrogen delivered by the health care professional for a maximum of 4 treatments. |
| Primary outcome measure(s) | Complete clearance of all verrucae as observed on digital photographs taken at baseline and 12 weeks and assessed by an independent health care professional. |
| Secondary outcome measure(s) | 1. Self-reported clearance of verrucae at 6 months
2. Self-reported time to clearance of verrucae
3. Data will also be collected on side effects of treatment, pain intensity after treatment, use of painkillers, restrictions to lifestyle due to having verrucae, treatment details and patient satisfaction with treatment. |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) |
| Sponsor name | University of York (UK) |
| Sponsor details | Ms Sue Final
Intellectual Property Manager
Research Office
University of York
York
United Kingdom
YO10 5DG |
| Sponsor telephone | +44 (0)1904 434401 |
| Sponsor fax | +44 (0)1904 435101 |
| Sponsor email | smf3@york.ac.uk |
| Contact name | Prof David Torgerson |
| Contact details | Health Sciences
University of York
Seebohm Rowntree Building
Heslington
York
United Kingdom
YO10 5DD |
| Contact telephone | +44 (0)1904 321736 |
| Contact fax | +44 (0)1904 321388 |
| Contact email | esc5@york.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN18994246 |
| Date last extracted from ISRCTN register | 17/04/2008 |
