To assess the efficacy, evaluate the safety and immunological effect of topical 5% imiquimod cream for vulvar Paget*s disease and the quality of life during treatment.
ID
Source
Brief title
Condition
- Vulvovaginal disorders (excl infections and inflammations)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main outcome is the clinical response to treatment with topical 5%
imiquimod cream, defined as a complete remission, partial remission or no
remission. Complete remission is defined as disappearance of the lesion and
histological confirmation of disappearance. Partial remission is defined as
decrease by *50% of total lesion size. No response is defined as <50% decrease
of total lesion size.
Secondary outcome
Secondary outcome is the safety of topical 5% imiquimod cream, assessed by
recording all adverse events; immunological response will be assessed by
different immunological markers (which are currently studied in a pilot trial)
and the quality of life during treatment will be assessed by 3 questionnaires,
EQ5D, DLQI and (if applicable) FSDS.
Background summary
Extra Mammary Paget*s disease (EMPD) is a rare skin tumour, usually of the
genitalia in elderly women. Vulvar Paget*s disease is generally seen in
postmenopausal, Caucasian women as an erythematous, eczematous, scaling or
ulcerating plaque. Initial symptoms are irritation, burning, pain and a skin
lesion. The origin of EMPD is not yet entirely understood. The treatment of
choice is surgical excision, despite high recurrence rates. The mutilating
consequences of surgery will lead to impressive morbidity in elderly women. To
address this, a few studies have investigated the use of topical 5% imiquimod
cream for vulvar Paget*s disease. Topical 5% imiquimod cream seems to be a
successful treatment option for a subset of women with vulvar Paget*s disease.
Study objective
To assess the efficacy, evaluate the safety and immunological effect of topical
5% imiquimod cream for vulvar Paget*s disease and the quality of life during
treatment.
Study design
Prospective, multi-centre, observational, open-label, intervention study.
Intervention
All patients use topical 5% imiquimod cream 3 times a week for 16 weeks. In
case of side effects patients are allowed to use lidocain ointment and/or
painkillers, or to adjust the frequency to 2 times a week or to pause treatment
for 1 week.
Study burden and risks
Before inclusion to this study, patients will have undergone a vulvar biopsy
and mapping for diagnostic purposes. Vulvar Paget*s disease is associated with
underlying carcinomas, additional mammography will be performed. After
inclusion patients will visit the clinic 7 times and will have a consultation
by phone once during treatment. The final check-up will take place 1 year after
the end of treatment. Patients will undergo anogenital inspection, measurement
and photo documentation at 3 separate visits. They will fill out 3 different
questionnaires at 3 different times and record a patient diary at home.
Patients will undergo a biopsy 3 times, twice as standard care for diagnostic
purposes before and after treatment. An additional biopsy will be carried out
4 weeks after the start of treatment to evaluate the immunological effect of 5%
imiquimod cream. Topical 5% imiquimod cream is registered for the use of
condylomata acuminata and included patients will be treated accordingly, this
schedule is also proven to be effective and safe in a randomized controlled
trial for the treatment of usual vulvar intraepithelial neoplasia (uVIN). Based
on these experiences it is considered a safe treatment and an attractive
alternative for women with vulvar Paget*s disease instead of mutilating
surgery.
Geert Grooteplein 10
Nijmegen 6525 GA
NL
Geert Grooteplein 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
- Non invasive vulvar Paget's disease, primary or recurrence after previous surgery
- Age 18 and older
Exclusion criteria
- invasive vulvar Paget's disease
- underlying adenocarcinoma
- previous treatment of the vulva with 5% imiquimod cream during the last 6 months
- patients with autoimmune disorders
- immune compromised patients
- pregnant women
- lactating women
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 | EUCTR2014-005276-29-NL |
| ClinicalTrials.gov | NCT02385188 |
| CCMO | NL51648.091.14 |