The objective is to assess the effect of adalimumab on selfconfidence and sexuality of patients with anogenital psoriasis.
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Lower scores on the measuring questionnaires.
Secondary outcome
None
Background summary
Psoriasis is a chronic inflammatory disease of the skin of unknown
etiology.About 2-3% of the world population is affected by it. It is
accompanied by heavy psychological burden. Altough psoriasis usually manifests
on knees, elbows and the head, lesions in anogenital region are frequently
seen.There are indications that the experience of sexuality can be nefatively
influenced by it. On assessment of severity of psoriasis this is not taken into
account. It is to be expected that this problem will improve with treatment of
psoriasis. Validated questionnaires exist for evaluation of sexuality, self
confidence and relationships: DS-c (inventory of depressive symptomatology),
SEAR (Self-Esteem and Relationship), IIEF (International Index of Erectile
Dysfunction) en FSFI(Female Sexual Function Index) . They have been designed to
measure the problems we are trying to assess. The PSOGEN questionnaire is
designed by the study team and will show difference in how ano-genital
psoriasis versus psoriasis in other body sites is experienced by the patients.
Also the way in which patients grade the importance of sexuality and intimacy
can be expressed by this instrument.
Study objective
The objective is to assess the effect of adalimumab on selfconfidence and
sexuality of patients with anogenital psoriasis.
Study design
This is a prospective study conducted in two hospitals in Netherlands. It is a
pilot which will eventually lead to a controled double blind trial.
Study burden and risks
Filling in the questionnares and physical and psychological examination cost
time.
No benefit to patients is to be expected from this study.
gk016 Burg. 's Jacobplein 51
3015 CE, Rotterdam
NL
gk016 Burg. 's Jacobplein 51
3015 CE, Rotterdam
NL
Listed location countries
Age
Inclusion criteria
-Having psoriasis of the anogenital region
-The patient will be treated with adalimumab by attending physician
Exclusion criteria
-Younger than 18
-Homosexual
-Unwilling to participate
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 | EUCTR2009-011625-13-NL |
CCMO | NL26555.078.09 |