|
Main
|
|
Note: This record shows only the 20 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. |
|
Register:
|
Netherlands Trial Register |
|
Last refreshed on:
|
28 April 2013 |
|
Main ID: |
NTR419 |
|
Date of registration:
|
22/09/2005 |
|
Primary sponsor: |
|
|
Public title:
|
Randomised controlled trial of the treatment of warts in general practice.
|
|
Scientific title:
|
Randomised controlled trial of the treatment of warts in general practice. - WARTS: WArts Randomized Treatment Study |
|
Date of first enrolment:
|
1/3/2006 |
|
Target sample size:
|
250 |
|
Recruitment status: |
pending |
|
URL:
|
http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=419 |
|
Study type:
|
intervention |
|
Study design:
|
Randomised: Yes; Masking: None; Control: Not applicable; Group: Parallel; Type: -
|
|
|
Countries of recruitment
|
|
The Netherlands
| | | | | | | |
|
Contacts
|
|
Name:
|
J.A.H.
Eekhof |
|
Address:
|
Leiden University Medical Center (LUMC),
P.O. Box 2088
2301 CB
Leiden
The Netherlands |
|
Telephone:
|
+31 (0)71 5275318 |
|
Email:
|
j.a.h.eekhof@lumc.nl |
|
Affiliation:
|
|
|
|
Name:
|
J.A.H.
Eekhof |
|
Address:
|
Leiden University Medical Center (LUMC),
P.O. Box 2088
2301 CB
Leiden
The Netherlands |
|
Telephone:
|
+31 (0)71 5275318 |
|
Email:
|
j.a.h.eekhof@lumc.nl |
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
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 who 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: Exclusion criteria are: immuno-incompetent patients and mosaic warts larger than 1 cm in diameter.
Age minimum:
Age maximum:
Gender:
|
|
Health Condition(s) or Problem(s) studied
|
Warts (Verruca vulgaris)
|
|
Intervention(s)
|
Treatment arms
For the treatment with cryotherapy we chose for a high-intensity regimen: a 2-weekly consultation till the
wart has disappeared (until max. 13 weeks), 3 applications of the same wart per session, each application
until a frozen halo appears of 2 mm around it?s base.
For the local treatment with salicylic acid vaseline album (petrolatum) we use 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 choose for 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 (max. until 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 will reliably reflect patient behaviours,
including seeking of additional therapy (ability to maintain the expectantly awaiting policy).
|
|
Primary Outcome(s)
|
The primary outcome is defined as ?cure', which means that the wart(s) have totally disappeared (normal skin) at 13 weeks.
|
|
Secondary Outcome(s)
|
1. The number of warts that still exists at follow-up, irrespective of the extent of regression (because for a separate wart regression can not 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
subjective judgement of the effect of the treatment by the research nurse at follow-up;
6. Referral to a dermatological department , assessed at 26 weeks
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;
7. The consumption of co-interventions during the intervention period and thereafter will also be used as
secondary endpoints.
|
|
Secondary ID(s)
|
|
ISRCTN42730629
|
|
N/A
|
|
Source(s) of Monetary Support
|
|
ZON-MW, The Netherlands Organization for Health Research and Development
|
|