PSOGEN:Effect adalimumab op zelfbeeld en seksueel functioneren bij matige en ernstige psoriasis van de anogenitale regio; prospectief, open label pilot onderzoek - PSOGE
- Conditions
- Anogenital PsoriasisMedDRA version: 1Level: LLTClassification code 10016776Term: <Manually entered code. Term in E.1.1>
- Registration Number
- EUCTR2009-011625-13-NL
- Lead Sponsor
- Abbott
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Patient has moderate to severe anogenital psoriasis.
Patient is over 18 years old.
Patient is heterosexual.
Treatment with adalimumab is to be started by attending dermatologist.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Patient is unwilling to participate.
Patient is homosexual.
Patient is younger than 18 years.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To asses the effect of improvement of anogenital psoriasis on sexual function in patients treated with adalimumab.;Secondary Objective: To assess the psychosexual problems in a population of patients with anogenital psoriasis.;Primary end point(s): Reduction of PASI and questionnare scores.<br>Reduction of scores in questionnares:<br>-Skindex<br>-PASI<br>-SEAR<br>-IIEF<br>-FSF<br>-HADS
- Secondary Outcome Measures
Name Time Method