Xamiol®Gel in BODY Psoriasis: A One-year Non-interventional Study
- Conditions
- Psoriasis Vulgaris
- Registration Number
- NCT02636101
- Lead Sponsor
- LEO Pharma
- Brief Summary
This study aims to describe the patient population treated and the real-life patients' experiences with Xamiol®gel in the long term, up to 52 weeks management of body psoriasis vulgaris in Russia. The result will increase the knowledge on Xamiol®gel enabling dermatologists and patients to optimize its use in the long term management of psoriasis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 603
- Psoriasis vulgaris on body
- Patients planned to receive topical treatment on the body with calcipotriol/betamethasone gel
- Written informed consent
- No or very mild symptoms of psoriasis vulgaris on the body at study start
- Any on-going treatments at study start with topical steroids, salicylic acid or its combination
- Other topical treatment for body psoriasis
- Pregnancy or planned pregnancy within treatment period
- Contraindications according to prescribing information.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adherence to treatment Around 8 weeks after treatment initiation Number of days during the last 7 days with no treatment
Patient reported treatment satisfaction Around 8 weeks after treatment initiation Patient preference compared with previous therapy
- Secondary Outcome Measures
Name Time Method Frequency of treatment after completion of initial treatment 12 months Physician Global Assessment of Psoriasis Around 8 weeks after treatment initiation Overall rate of treatment success Around 8 weeks Clear or almost clear by Physician Psoriasis Global Assessment
To evaluate the effect of treatment with Xamiol®gel on patients quality of life Around 8 weeks Dermatology Life Quality Index (DLQI)
Patient's willingness to pay 12 months Total consumption during study period in Russia where Xamiol®gel is not reimbursed
Trial Locations
- Locations (1)
Municipal out-patient clinic 7
🇷🇺Saratov, Russian Federation