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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN42730629 |
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Date of registration:
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27/01/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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WArts Randomised Treatment Study
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Scientific title:
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Randomised controlled trial of the treatment of warts in general practice |
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Date of first enrolment:
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01/03/2006 |
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Target sample size:
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250 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN42730629 |
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Study type:
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Interventional |
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Study design:
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Multicentre, randomised controlled parallel group trial (Treatment)
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Phase:
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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J.A.H.
Eekhof |
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Address:
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Leiden University Medical Centre
P.O. Box 2088
2301 CB
Leiden
Netherlands |
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Telephone:
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+31 (0)71 527 5318 |
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Email:
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j.a.h.eekhof@lumc.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: All patients from the age of 4 onward, who present themselves to their practice with one or more new warts of the type vulgaris on hands or feet will be included. New warts are warts which are presented for the first time in the general practice by patients who have had no general practice (or dermatological) treatment for warts in the past year. For all patients duration of presence of the warts and the previous treatment(s) will be registered.
Exclusion criteria: Immuno-incompetent patients and mosaic warts larger than 1 cm in diameter.
Age minimum:
Age maximum:
Gender:
Not Specified
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Health Condition(s) or Problem(s) studied
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Warts (Verruca vulgaris)
Infections and Infestations
Viral warts
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Intervention(s)
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Treatment arms:
For the treatment with cryotherapy we chose a high-intensity regimen: a 2-weekly consultation till the wart has disappeared (maximum 13 weeks), 3 applications of the same wart per session, each application until a frozen halo appears of 2 mm around its base.
For the local treatment with salicylic acid vaseline album (petrolatum) we used a once a day application of a concentration of 40% for warts on the sole of the feet and on other parts of the skin. We chose a concentration of 40% to offer patients a stronger therapy than the over-the-counter therapies (like Formule-W), which have a concentration of 17%. Covering the skin up with tape will protect the skin around the wart. Application will be continued till the wart has disappeared (maximum 13 weeks).
Patients who were randomised into the natural history arm will be informed about the high spontaneous cure rate. We refrained from a placebo-comparison because this insufficiently resembles daily practice. An expectantly awaiting group will in the intervention period reliably reflect patient behaviours, including seeking of additional therapy (ability to maintain the expectantly awaiting policy).
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Primary Outcome(s)
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?Cure', meaning that the wart(s) have totally disappeared (normal skin) at 13 weeks.
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Secondary Outcome(s)
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1. The number of warts that still exist at follow-up, irrespective of the extent of regression (because for a separate wart regression cannot be validly assessed)
2. The subjective hindrance caused by the warts as scored by the patient on a numerical rating scale (0 - 10)
3. The subjective hindrance caused by the treatment as scored by the patient on a seven point scale (during the treatment period this will be scored weekly in a booklet)
4. Pain and other adverse effects of the treatments (pain, new warts, scars, irritation of the skin, dermatitis discomfort, invalidation, time)
5. Subjective judgement of the effect of the treatment by the patient at follow-up
6. Subjective judgement of the effect of the treatment by the research nurse at follow-up
7. Referral to a dermatological department, assessed at 26 weeks
8. After three months of the intervention period, patients for whom the warts have not disappeared are free to switch therapy. In the follow-up period we will carefully register to which therapies patients have switched and also if, and after how long this therapy leads to total disappearance of the warts.
9. The consumption of co-interventions during the intervention period and thereafter will also be used as secondary endpoints
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Source(s) of Monetary Support
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The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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