WArts Randomised Treatment Study
| ISRCTN | ISRCTN42730629 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42730629 |
| Secondary identifying numbers | NTR419 |
- 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
Scientific
Leiden University Medical Centre
P.O. Box 2088
Leiden
2301 CB
Netherlands
| Phone | +31 (0)71 527 5318 |
|---|---|
| j.a.h.eekhof@lumc.nl |
Study information
| Study design | Multicentre, randomised controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/03/2006 |
| Completion date | 01/03/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 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
2301 CB
Netherlands
Sponsor information
Sponsor not yet defined (The Netherlands)
Not defined
Not defined
-
-
-
Netherlands
Funders
Funder type
Research organisation
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
