An investigation of the effect of Vitamin D Receptor genotypes on clinical response to treatment of psoriasis with a topical vitamin D analogue and molecular mechanisms
- Conditions
- Psoriasis - an inflammatory skin disease with a genetic basis
- Registration Number
- EUCTR2005-000546-37-GB
- Lead Sponsor
- niversity Hospitals of Leicester NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
1. Patients aged 18 to 80 years who have psoriasis
2. Patients who are not currently having oral therapy or phototherapy for their psoriasis and have not received these therapies within the previous 3 months
3. Females of child-bearing potential who provide a negative urine pregnancy test and who agree not to become pregnant during the duration of the study
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) yes
F.1.3.1 Number of subjects for this age range
1. Pregnant or breast-feeding females
2. Patients who have previously experienced local skin irritation from calcipotriol (Dovonex)
3. Patients who have received oral or photo-therapy for psoriasis during the preceding 3 months
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the effect of naturally occurring genetic variations (polymorphisms) in the Vitamin D receptor (VDR) gene on the response of psoriasis to treatment with a Vitamin D analogue product (Dovonex). ;Secondary Objective: To determine whether the underlying mechanism of response is determined by immunological molecular mechanisms.;<br> Primary end point(s): The primary end point is the assessment of response of the plaques of psoriasis to the application of Dovonex ointment twice daily for 4 weeks. Response will be assessed in terms of erythema, induration and scaling of each plaque.<br> This data will then be used to determine if there is a realationship between response to topical Dovonex and Vitamin D Receptor genotypes.<br>
- Secondary Outcome Measures
Name Time Method