WArts Randomised Treatment Study

ISRCTN	ISRCTN42730629
DOI	https://doi.org/10.1186/ISRCTN42730629
Protocol serial number	NTR419
Sponsor	Sponsor not yet defined (The Netherlands)
Funder	The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Submission date: 27/01/2006
Registration date: 27/01/2006
Last edited: 06/01/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr J.A.H. Eekhof
Scientific

Leiden University Medical Centre
P.O. Box 2088
Leiden
2301 CB
Netherlands

Phone	+31 (0)71 527 5318
Email	j.a.h.eekhof@lumc.nl

Study information

Primary study design	Interventional
Study design	Multicentre, randomised controlled parallel group trial
Secondary study design	Randomised controlled trial
Scientific title	Randomised controlled trial of the treatment of warts in general practice
Study acronym	WARTS
Study objectives	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(s)	Received from the local medical ethics committee
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Salicylic acid
Primary outcome measure(s)	Cure', meaning that the wart(s) have totally disappeared (normal skin) at 13 weeks.
Key secondary outcome measure(s)	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
Completion date	01/03/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target sample size at registration	250
Key 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.
Key exclusion criteria	Immuno-incompetent patients and mosaic warts larger than 1 cm in diameter.
Date of first enrolment	01/03/2006
Date of final enrolment	01/03/2008

Locations

Countries of recruitment

Netherlands

Study participating centre

Leiden University Medical Centre

Leiden
2301 CB
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	19/10/2010		Yes	No
Results article	results	01/07/2013		Yes	No