The aim of this study is to compare the effect of early treatment on healing and quality of life with the usual expectant policy in children with mollusca contagiosa.
ID
Source
Brief title
Condition
- Skin and subcutaneous tissue disorders NEC
- Skin and subcutaneous tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is the difference in total healing (no mollusca
present) after 26 weeks between the intervention and control groups.
Secondary outcome
Secondly, we will look at the differences between the groups with regard to,
symptoms, the perceived quality of life, side effects of the treatments,
subjective experience of the treatment undergone, the number and nature of
possible co-interventions and possible transmission of mollusca within the
family.
Background summary
Molluscum contagiosum or water warts is a common everyday disease that mainly
affects children aged 1 to 14 years (prevalence 5-11%) [1]. It usually starts
with a few lesions and can spread to a few dozen. In most cases, it takes more
than a year for spontaneous healing to occur, but often longer [2]. For a
significant proportion of patients, the condition has a significant negative
effect on their quality of life, especially if there is a higher number of
lesions and the lesions last longer [2].
In order to arrive at a well-considered choice whether to treat or not and to
choose the most suitable treatment option, it is important to know how
effective the different options are. Early intervention may have a positive
effect on the course and complaints compared to waiting for spontaneous
recovery. However, there is still insufficient evidence and none of the
treatments has yet been demonstrated to be effective [3].
Study objective
The aim of this study is to compare the effect of early treatment on healing
and quality of life with the usual expectant policy in children with mollusca
contagiosa.
Study design
It is a prospective randomized study.
Intervention
The two most common interventions in the Netherlands, cryotherapy and curettage
[3, 4], are compared with an expectant policy. The participants will be
randomized at inclusion on three research arms with the same number of
participants in each arm.
Study burden and risks
Cryotherapy and curettage are two limited invasive treatment methods that will
therefore be performed according to the guideline [4] under local anesthesia
using EMLA cream. EMLA cream is a proven effective surface anesthetic and is
used to prevent possible pain during treatment as much as possible. In addition
to any itching complaints as a result of the treatment, there is a small chance
of complications, including wound infection, blistering and scarring. Any
complications during or after treatment will be reported and, if necessary,
treated additionally in accordance with the applicable guidelines. In addition,
the test subject and parents or legal representative will be charged with the
first (home) visit, the questionnaires to be administered and follow-up.
Naturally, extensive verbal and written explanations will be given in advance
as part of the informed consent procedure.
Gebouw 3, verdieping 6, Hippocratespad 21
LEIDEN 2333 RC
NL
Gebouw 3, verdieping 6, Hippocratespad 21
LEIDEN 2333 RC
NL
Listed location countries
Age
Inclusion criteria
Children (4 - 18 years old) with Molluscum contagiosum (maximum of 15 lesions)
Exclusion criteria
- Immunodeficient / immunocompromised children;
- Facial involvement and/or anogenital involvement;
- (Known) extreme fear of invasive medical procedures (such as curettage or
cryotherapy);
- Recent (<1 year) treatmtent of molluscum contagiosum with one of the
treatment modalities being investigated in this study, i.e. curettage and/or
cryotherapy
Design
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL74903.058.20 |
| OMON | NL-OMON20359 |