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Cryotherapy versus salicylic acid for the treatment of verrucae: a randomised controlled trial
ISRCTN ISRCTN18994246
DOI 10.1186/ISRCTN18994246
ClinicalTrials.gov identifier
EudraCT number
Public title Cryotherapy versus salicylic acid for the treatment of verrucae: a randomised controlled trial
Scientific title
Acronym EVERT (Effective Verruca Treatments)
Serial number at source HTA 05/513/02
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).

More details can be found at http://www.hta.ac.uk/project/1532

Please note that, as of 11/01/2008, the anticipated end date of this trial has been updated from 01/01/2009 to 31/12/2008.

Please note that, as of 11/05/2009, the end date of this trial record has been updated from 31/12/2008 to 30/06/2010.
Lay summary Background and study aims:
There are many different ways to treat verrucae, but there is very little evidence to tell healthcare professionals which is the best treatment. This trial compared two widely used verruca treatments, salicylic acid and freezing with liquid nitrogen (cryotherapy) to see which one was the best treatment.

Who can participate?
Patients over the age of 12 years with a verruca which could be treated with salicylic acid and cryotherapy could take part in the trial.

What does the study involve?
Patients either treated their verruca at home every day with salicylic acid for eight weeks or went to a healthcare professional, who used a freezing agent to treat their verruca for a maximum of 4 treatments. Patients also filled in some questionnaires and went to the clinic after 12 weeks so that the healthcare professional could see if their verruca had gone.

What are the possible benefits and risks of participating?
We hoped that people taking part in the study would have their verruca cured, however this could not be guaranteed. The information we gained from this study will now help healthcare professionals decide which sort of treatment to use with their patients. As the two treatments are widely used, we did not expect there to be any additional risks compared to routine practice.

Where is the study run from?
The EVerT study was run by the University of York, Department of Health Sciences, York Trials Unit.

When is the study starting and how long is it expected to run for?
The study started in October 2006 and finished in June 2010.

Who is funding the study?
The study was funded by UK NIHR Health Technology Assessment Programme.

Who is the main contact?
Mrs Sarah Cockayne
sarah.cockayne@york.ac.uk
Ethics approval UK MREC approval on the 26th of October 2004 (MREC ref: 04/MRE04/59)
Study design Pragmatic multi-centre two-arm randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Verrucae (plantar warts)
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
Anticipated start date 01/10/2006
Anticipated end date 30/06/2010
Status of trial Completed
Patient information material
Target number of participants 266
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)
Trial website
Publications 1. 2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20141630
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21652750
3. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21899812
4. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23146114
Contact name Prof  David  Torgerson
  Address Health Sciences
University of York
Seebohm Rowntree Building
Heslington
  City/town York
  Zip/Postcode YO10 5DD
  Country United Kingdom
  Tel +44 (0)1904 321736
  Fax +44 (0)1904 321388
  Email esc5@york.ac.uk
Sponsor University of York (UK)
  Address Ms Sue Final
Intellectual Property Manager
Research Office
University of York
  City/town York
  Zip/Postcode YO10 5DG
  Country United Kingdom
  Tel +44 (0)1904 434401
  Fax +44 (0)1904 435101
  Email smf3@york.ac.uk
Date applied 07/12/2006
Last edited 03/12/2012
Date ISRCTN assigned 08/12/2006
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