To assess the efficacy of treatment with monochloroacetic compared to treatment with cryotherapy regarding patients with handwarts and compared to combination therapy (salicylic acid and cryotherapy) regarding patients with plantar warts.WARTS-1 has…
ID
Source
Brief title
Condition
- Viral infectious disorders
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
*Cure', meaning all hand- or plantar wart(s) have totally disappeared (normal
skin) at 13 weeks.
Secondary outcome
The number of warts that still exist at follow-up, the subjective hindrance
caused by the warts as well as by the treatment, pain and other adverse effects
of the treatment, subjective judgement of the effect of the treatment by the
patient, objective judgement of the effect of the treatment by the research
nurse at follow up, referral to a dermatological department and the consumption
of co-interventions during intervention period.
Background summary
WArts Randomised Treatment Study of 2006 compared treatment with salicylic acid
to treatment with cryotherapy and both treatments to expectantly policy.
Results show that the best treatment for hand warts is cryotherapy (cure rate
50%). In case of plantar warts neither treatment with salicylic acid nor with
cryotherapy showed better results than awaiting policy (30% cure rates).
Although cryotherapy is an effective treatment for hand warts, still 1 out of 2
patients treated with cryotherapy receives a painful treatment without being
cured. Monochloroacetic could be an effective alternative without painful side
effects. However convincing evidence of the efficacy of this treatment is still
missing. The combination of cryotherapy and local treatment with salicylic acid
is commonly used in Dutch general practices for the treatment of plantar warts,
although evidence concerning this treatment is also lacking.
Study objective
To assess the efficacy of treatment with monochloroacetic compared to treatment
with cryotherapy regarding patients with handwarts and compared to combination
therapy (salicylic acid and cryotherapy) regarding patients with plantar warts.
WARTS-1 has provided answers on de main questions about treatment of warts in
general practice. With the results of WARTS-1 and WARTS-2 altogether we aim to
provide an evidence-based guideline regarding therapy for hand- or plantar
warts in general practice.
Study design
Multicentre, randomised controlled parallel group trial in 80 general
practices.
Intervention
Treatment of handwarts with either a saturated concentration of
monochloroacetic acid 76% or with cryotherapy.
Treatment of plantar warts with either a saturated concentration of
monochloroacetic acid 76% or with the combination therapy of salicycic acid 40%
and cryotherapy.
Study burden and risks
Treatment of hand- and plantar warts with salicylic acid, cryotherapy and
monochloroacetic acid are common treatments for warts in general practice.
Therefore, by participating to this study there are no extra risks for
patients.
Postbus 9600
2300 RC Leiden
NL
Postbus 9600
2300 RC Leiden
NL
Listed location countries
Age
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 verruca vulgaris on hands or feet will be included.
New warts are warts which are presented for the first time in their general practice by patients who have had no general practice (or dermatological) treatment for warts in the past year.
Exclusion criteria
Immunocompromised patients
Patients with mosaic warts larger than 1 cm in diameter
Patients with warts who are pregnant or who are breastfeeding
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2009-012210-48-NL |
| CCMO | NL27534.058.09 |