Contact information
Type
Scientific
Primary contact
Dr J.A.H. Eekhof
ORCID ID
Contact details
Leiden University Medical Centre
P.O. Box 2088
Leiden
2301 CB
Netherlands
+31 (0)71 527 5318
j.a.h.eekhof@lumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR419
Study information
Scientific title
Randomised controlled trial of the treatment of warts in general practice
Acronym
WARTS
Study hypothesis
The usual treatment for warts in Dutch general practice is cryotherapy with liquid nitrogen. More than 50% of all warts are treated with cryotherapy alone and in only 14% salicylic acid is used as mono-therapy.
The prestigious Cochrane review concludes that there is an urgent need for high-quality randomised controlled trials on the routine treatments for common warts, particularly cryotherapy. While there is convincing evidence for the efficacy of topical salicylic acid compared to placebo,
high quality studies in which cryotherapy and salicylic acid are compared to natural history are still lacking.
According to the Cochrane review the most urgent need is for a trial to compare topical salicylic acid, cryotherapy and placebo. Since the most recent amendment (May 2003) no new studies are published.
Ethics approval
Received from the local medical ethics committee
Study design
Multicentre, randomised controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Warts (Verruca vulgaris)
Intervention
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).
Intervention type
Drug
Phase
Not Specified
Drug names
Salicylic acid
Primary outcome measure
Cure', meaning that the wart(s) have totally disappeared (normal skin) at 13 weeks.
Secondary outcome measures
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
Overall trial start date
01/03/2006
Overall trial end date
01/03/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
250
Participant exclusion criteria
Immuno-incompetent patients and mosaic warts larger than 1 cm in diameter.
Recruitment start date
01/03/2006
Recruitment end date
01/03/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Leiden University Medical Centre
Leiden
2301 CB
Netherlands
Funders
Funder type
Research organisation
Funder name
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Basic results (scientific)
Publication list
2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20837684
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23518443
Publication citations
-
Results
Bruggink SC, Gussekloo J, Berger MY, Zaaijer K, Assendelft WJ, de Waal MW, Bavinck JN, Koes BW, Eekhof JA, Cryotherapy with liquid nitrogen versus topical salicylic acid application for cutaneous warts in primary care: randomized controlled trial., CMAJ, 2010, 182, 15, 1624-1630, doi: 10.1503/cmaj.092194.
-
Results
Bruggink SC, Gussekloo J, de Koning MN, Feltkamp MC, Bavinck JN, Quint WG, Assendelft WJ, Eekhof JA, HPV type in plantar warts influences natural course and treatment response: secondary analysis of a randomised controlled trial., J. Clin. Virol., 2013, 57, 3, 227-232, doi: 10.1016/j.jcv.2013.02.021.