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WArts Randomised Treatment Study 2.


- candidate number5635
- NTR NumberNTR1771
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-apr-2009
- Secondary IDs80-81000-98-099 ZonMW
- Public TitleWArts Randomised Treatment Study 2.
- Scientific TitleMonochloroacetic acid versus cryotherapy or combination therapy in the treatment of warts: A Randomised Clinical Trial.
- ACRONYMWARTS-2
- hypothesisResults of WArts Randomised Treatment Study of 2006 show that the best treatment for common warts is cryotherapy compared to salicylic acid or awaiting policy (after 13 weeks). In case of plantar warts none of either treatments (cryotherapy or salicylic acid) is better than awaiting policy (30% cure rate after 13 weeks). Pain is a common side effect of treatment with cryotherapy. Although cryotherapy is an effective treatment for common warts, still 1 out of 2 patients treated with cryotherapy receive a painful treatment without being cured. Two small studies in dutch general practices show that monochloroacetic acid could be an effective alternative for the treatment of warts without painful side effects. Steele et al found higher cure rates for patients treated with the combination of monochloroacetic acid and local treatment with salicylic acid compared to patients treated with placebo. However convincing evidence of the efficacy of treatment with monochloroacetic acid as monotherapy is still lacking. The combination of cryotherapy and local treatment with salicylic acid is commonly used in Dutch general practices, although evidence lacks. Since individual treatment of both salicylic acid and cryotherapy showed no better cure rates in plantar warts than awaiting policy, we chose to compare two possibly promising treatments: treatment with monochloroacetic acid and the combination therapy of salicylic acid and cryotherapy.
- Healt Condition(s) or Problem(s) studiedWarts (Verruca vulgaris)
- Inclusion criteriaAll patients from the age of 4 onward, who present themselves to their general practitioner with one or more new warts of the type vulgaris on commons or feet.
- Exclusion criteriaImmunocompromised patients, patients with mosaic warts larger than 1 cm in diameter, women who are pregnant or who are breastfeeding their children.
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2009
- planned closingdate1-sep-2010
- Target number of participants400
- InterventionsTreatment arms:


Common warts:
Monochloroacetic acid: We chose to use a saturated concentration of 76% of monochloroacetic acid for application on a 2 weekly basis.
Cryotherapy: We chose a regimen of a 2-weekly consultation with 3 applications of the same wart per session. Both treatments will be continued until the wart has disappeared (maximum 13 weeks).

Plantar warts:
Monochloroacetic acid: We chose to use a saturated concentration of 76%of monochloroacetic acid for application on a 2 weekly basis.

Combination therapy (salicylic acid + cryotherapy): The patient will be instructed to first apply salicylic acid in vaseline album (petrolatum) 40% at home every evening on the sole of the feet for 2 weeks. Thereafter the patient visits the general practice for treatment with cryotherapy, 3 applications of the same wart per session. This regimen of combination of both therapies will be continued until the wart has disappeared (maximum 13 weeks).
- Primary outcome‘Cure', meaning all common- and plantar wart(s) have totally disappeared (normal skin) at 13 weeks.
- Secondary outcomeThe number of warts that still exist at follow-up, the subjective hindrance caused by the warts as well as by the treatment, pain and other adverse effects of the treatment, subjective judgement of the effect of the treatment by the patient, objective judgement of the effect of the treatment by the research nurse at follow up, the consumption of co-interventions during follow-up.
- TimepointsAssesment by a research nurse will take place at the start, 4 and 13 weeks after the patient has started with the treatment. The research nurse will visit patient at home. Warts will be examined and a questionnaire will be taken, which takes on average 30 minutes.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. J.A.H. Eekhof
- CONTACT for SCIENTIFIC QUERIESDr. J.A.H. Eekhof
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development, funding Daily Diseases
- PublicationsN/A
- Brief summaryWarts are a common problem in general practice. Most often patients want warts to be treated due to pain or they find them ugly. Results of WARTS-1 show a significant efficacy of cryotherapy for the treatment of common warts. Although still 1 out of 2 patients receive a painful treatment without being cured. For plantar warts none of the studied treatments showed better results than expectantly policy. In WARTS-2 we will study the effect of the promising treatment with monochloroacetic acid compared to cryotherapy on common warts. In case of plantar warts we compare monochloroacetic acid with the combined treatment of salicylic acid and cryotherapy. Using the results of WARTS-1 and WARTS-2 we aim to develop an evidence-based guideline for the treatment of common- and plantar warts.
- Main changes (audit trail)03-06-09: updates, below the first version:
SCIENTIFIC TITLE: Monochloroacetic acid versus cryotherapy in the treatment of warts: A Randomised Clinical Trial.
INCLUSION CRITERIA: All patients from the age of 4 onward, who present themselves to their general practioner with one or more new warts of the type vulgaris on commons or feet will be included. New warts are warts which are presented for the first time in the general practice by patients or who have had no general practice (or dermatological) treatment for warts in the past year.
MASKING/BLINDING: none.
INTERVENTIONS: Treatment arms:
Common warts:
For the treatment with monochloroacetic acid we use a concentration of 80%. We chose a regimen of a 2-weekly consultation with application of monochloroacetic acid on the wart. For the treatment with cryotherapy we chose a regimen of a 2-weekly consultation with 3 applications of the same wart per session. Both treatments will be continued until the wart has disappeared (maximum 13 weeks).
Plantar warts:
For the treatment with monochloroacetic acid we use a concentration of 80%. We chose a regimen of a 2-weekly consultation with application of monochloroacetic acid on the wart. For the combination of cryotherapy and local treatment with salicylic acid the patient will be instructed to first apply salicylic acid in vaseline album (petrolatum) 40% at home every evening on the sole of the feet for 2 weeks. Thereafter the patient visits the general practice for treatment with cryotherapy, 3 applications of the same wart per session. This regimen of combination of both therapies will be continued until the wart has disappeared (maximum 13 weeks).
FONDS: The Dutch Organisation for Health Research and Development (ZonMw) (The Netherlands).
- RECORD20-apr-2009 - 18-dec-2009


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