Cryotherapy versus salicylic acid for the treatment of verrucae
| ISRCTN | ISRCTN18994246 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18994246 |
| Secondary identifying numbers | HTA 05/513/02 |
- Submission date
- 07/12/2006
- Registration date
- 08/12/2006
- Last edited
- 15/07/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
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
Contact information
Scientific
Health Sciences
University of York
Seebohm Rowntree Building
Heslington
York
YO10 5DD
United Kingdom
| Phone | +44 (0)1904 321736 |
|---|---|
| esc5@york.ac.uk |
Study information
| Study design | Pragmatic multi-centre two-arm randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Cryotherapy versus salicylic acid for the treatment of verrucae: a randomised controlled trial |
| Study 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(s) | UK MREC approval, 26/10/2004, MREC ref: 04/MRE04/59 |
| Condition | Verrucae (plantar warts) |
| Intervention | 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. |
| Intervention type | Mixed |
| Primary outcome measure | 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 study start date | 01/10/2006 |
| Overall study end date | 30/06/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 266 |
| 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 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
- England
- United Kingdom
Study participating centre
YO10 5DD
United Kingdom
Sponsor information
University/education
Ms Sue Final
Intellectual Property Manager
Research Office
University of York
York
YO10 5DG
England
United Kingdom
| Phone | +44 (0)1904 434401 |
|---|---|
| smf3@york.ac.uk | |
"ROR" |
https://ror.org/04m01e293 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 08/02/2010 | Yes | No | |
| Results article | results | 07/06/2011 | Yes | No | |
| Results article | results | 01/09/2011 | Yes | No | |
| Results article | results | 12/11/2012 | Yes | No | |
| Results article | results | 12/07/2016 | Yes | No |
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.
