Verrucae
Conditions
Interventions
Trade Name: Verrugon
Product Name: Verrugon
Pharmaceutical Form: Cutaneous paste
INN or Proposed INN: Salicylic acid
CAS Number: 69-72-7
Sponsors
University of York
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients will be eligible to take part in the trial if the podiatrist confirms that they have a verruca that is suitable for treatment with either salicylic acid or cryotherapy. Patients who are able and willing to give informed consent. Clarification that patients should be eligible for 'both' forms of treatment. (Protocol version 5 4/5/2007) Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients will be ineligible to take part in the trial if they have impaired healing eg due to diabetes, peripheral vascular disease or any other condition which means the patient has impaired healing, if they are participating in another trial for the treatment of verrucae, or if they are unable to give informed consent. Patients under the age of 12 will be excluded since cryotherapy may be an inappropriate form of treatment for that age group. The following additional criteria have been included: Patients currently taking immunosuppressant drugs such as oral corticosteroids (Protocol 3 26/7/06) Patients 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 that are immunosuppressed eg have agammaglobulinaemia (Protocol v 4 21/11/06)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The trial is designed primarily to determine the effectiveness of cryotherapy versus salicylic acid for the treatment of plantar warts. ; Secondary Objective: Our secondary objectives are to determine patient acceptability of both treatments including possible side effects such as pain. We are also interested in how cost effective the two treatments are compred to one another. Protocol version 3 26th July 2006 added the following secondary outcomes - Self-reported time to clearance of verrucae - Recurrence/clearance of verrucae at six months ; Primary end point(s): The primary outcome is complete clearance of all verrucae, which will be assessed blindly at 12 weeks after randomisation. Primay end point is 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). Blind 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 (Protocol version 3 July 26th 2006) | — |
Countries
Ireland, United Kingdom
Outcome results
None listed