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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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-000546-37-GB
Enrollment
30
Registered
2005-02-24
Start date
2005-03-18
Completion date
Unknown
Last updated
2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis - an inflammatory skin disease with a genetic basis

Interventions

Trade Name: Dovonex ointment Product Name: Dovonex ointment Pharmaceutical Form: Ointment

Sponsors

University Hospitals of Leicester NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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.; 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. This data will then be used to determine if there is a realationship between response to topical Dovonex and Vitamin D Receptor genotypes.

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026