Condition category
Infections and Infestations
Date applied
07/12/2006
Date assigned
08/12/2006
Last edited
15/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English 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?
University of York (UK)

When is the study starting and how long is it expected to run for?
October 2006 to June 2010

Who is funding the study?
Health Technology Assessment Programme (UK)

Who is the main contact?
Mrs Sarah Cockayne
sarah.cockayne@york.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof David Torgerson

ORCID ID

Contact details

Health Sciences
University of York
Seebohm Rowntree Building
Heslington
York
YO10 5DD
United Kingdom
+44 (0)1904 321736
esc5@york.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 05/513/02

Study information

Scientific title

Cryotherapy versus salicylic acid for the treatment of verrucae: a randomised controlled trial

Acronym

EVERT (Effective Verruca Treatments)

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.nets.nihr.ac.uk/projects/hta/0551302
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0014/51233/PRO-05-513-02.pdf

Ethics approval

UK MREC approval, 26/10/2004, MREC ref: 04/MRE04/59

Study design

Pragmatic multi-centre two-arm randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Verrucae (plantar warts)

Intervention

Patients will be randomised equally between the two arms: daily self-treatment by the patient with 50% salicylic acid (VerrugonĀ®) 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.

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

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 measures

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.

Overall trial start date

01/10/2006

Overall trial end date

30/06/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

266

Participant 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

Recruitment start date

01/10/2006

Recruitment end date

30/06/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of York
York
YO10 5DD
United Kingdom

Sponsor information

Organisation

University of York (UK)

Sponsor details

Ms Sue Final
Intellectual Property Manager
Research Office
University of York
York
YO10 5DG
United Kingdom
+44 (0)1904 434401
smf3@york.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/20141630
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21652750
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21899812
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/23146114
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27408622

Publication citations

  1. Protocol

    Cockayne ES, , The EVERT (effective verruca treatments) trial protocol: a randomised controlled trial to evaluate cryotherapy versus salicylic acid for the treatment of verrucae., Trials, 2010, 11, 12, doi: 10.1186/1745-6215-11-12.

  2. Results

    Cockayne S, Hewitt C, Hicks K, Jayakody S, Kang'ombe AR, Stamuli E, Turner G, Thomas K, Curran M, Denby G, Hashmi F, McIntosh C, McLarnon N, Torgerson D, Watt I, , Cryotherapy versus salicylic acid for the treatment of plantar warts (verrucae): a randomised controlled trial., BMJ, 2011, 342, d3271.

  3. Results

    Cockayne S, Curran M, Denby G, Hashmi F, Hewitt C, Hicks K, Jayakody S, Kang'ombe A, McIntosh C, McLarnon N, Stamuli E, Thomas K, Turner G, Torgerson D, Watt I, , EVerT: cryotherapy versus salicylic acid for the treatment of verrucae--a randomised controlled trial., Health Technol Assess, 2011, 15, 32, 1-170, doi: 10.3310/hta15320.

  4. Results

    Cockayne S, Hicks K, Kangombe AR, Hewitt C, Concannon M, Thomas K, Hashmi F, McIntosh C, Brierley G, Torgerson D, Watt I, , The effect of patients' preference on outcome in the EVerT cryotherapy versus salicylic acid for the treatment of plantar warts (verruca) trial., J Foot Ankle Res, 2012, 5, 1, 28, doi: 10.1186/1757-1146-5-28.

  5. Results

    Cockayne S, Hewitt C, Hashmi F, Hicks K, Concannon M, McIntosh C, Thomas K, Hall J, Watson J, Torgerson D, Watt I, Implementation of blinded outcome assessment in the Effective Verruca Treatments trial (EverT) - lessons learned, J Foot Ankle Res, 2016 , 9, 21, doi: 10.1186/s13047-016-0155-4.

Additional files

Editorial Notes

15/07/2016: Publication reference added. 11/01/2008: the overall trial end date was changed from 01/01/2009 to 31/12/2008. 11/05/2009: the overall trial end date was changed from 31/12/2008 to 30/06/2010.