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Multinational real-life study of current psoriasis treatment strategies, topical treatment patterns and treatment outcomes of these treatments, including the newly introduced calcipotriol/betamethasone dipropionate aerosol foam fixed combination product Enstilar® (calcipotriol/betamethasone dipropionate).
This multinational study aims to describe current treatment patterns and outcomes in the diversity of the real life setting: local differences in access to drugs and current treatment practices, and regional cultural differences, covering adult patients of all backgrounds, sex, socio-economic standing, health background, comorbidity and co-medication. A total of around 1200 real-life prescribers in 15-20 countries around the globe are expected to participate over the years, with each country contributing data to the study for around 2 years, starting data collection within the first year after local market introduction of Enstilar®.
The real-life prescribing and utilization patterns of topical prescription products approved for treatment of psoriasis vulgaris in the individual participating countries will be mapped and performance of the products in real life will be investigated based primarily on baseline data from investigators and patient reported data contributed by the individual patient for 1 year. Patients are expected to enter data on their electronic device at baseline and at times of treatment changes and other key events, and investigators are expected to contribute data after each contact with the patient.
Patients will be approached for informed consent to participate in the study after their individual treatment plan has been decided. The study aims to include two patients on other topical treatment for every patient planned to receive Enstilar® in order to ensure a sufficient sample of Enstilar® treated patients to capture the diversity of real-life prescription patterns in patients not on Enstilar®, and to allow for sufficiently powered comparisons between Enstilar® and other real-world treatment strategies. A systematic approach will be used to select eligible patients to be approached for study participation in order to minimize selection bias and control seasonal variations.
Observational Model: Cohort, Time Perspective: Prospective
Enstilar® aerosol foam, Other topical
Not yet recruiting
Published on BioPortfolio: 2016-10-18T02:08:21-0400
A phase 3 trial comparing the efficacy and safety of LEO 90100 aerosol foam with the aerosol foam vehicle used twice weekly as long-term maintenance therapy in subjects with psoriasis vulg...
This study aims to assess how the Enstilar® aerosol foam performs in daily real-life practice with regards to effectiveness and convenience of application to psoriasis plaques on body and...
To gather insight on how product attributes affect usability by investigating the factors that are thought to influence patient preference to topical anti-psoriatic treatments.
The purpose of this study is to evaluate the anti-psoriatic effect of LEO 90100 aerosol foam compared with Betesil® medicated plaster
Calcipotriene is a vitamin D3 analog that has been used as topical therapy in adult subjects with plaque-type psoriasis since 1993. Calcipotriene foam, 0.005%, was approved in 2010 for the...
Aerosol Foam Formulation of Fixed Combination Calcipotriene Plus Betamethasone Dipropionate is Highly Efficacious in Patients With Psoriasis Vulgaris: Pooled Data From Three Randomized Controlled Studies.
Calcipotriene 0.005% (Cal)/betamethasone dipropionate 0.064% (BD) aerosol foam was developed as a new treatment option for patients with psoriasis. This pooled analysis evaluated the efficacy of this ...
The Aerosol Foam Formulation of the Fixed Combination Calcipotriene Plus Betamethasone Dipropionate Improves the Health-Related Quality of Life in Patients With Psoriasis Vulgaris: Results from the Randomized PSO-FAST Study.
Psoriasis has a major impact on patient quality of life, similar to that seen in other chronic diseases, eg, diabetes. Health-related quality of life (HRQoL) measures are commonly included in clinical...
There is a lack of response data for topical treatments for psoriasis vulgaris in Asian patients.
The toll-like receptors-(TLR)-2 and -4 play a role in the innate immune system and drive the autoimmune T cell cascade in psoriasis. But little is known about the association of the polymorphisms of T...
Single-agent therapy with a very potent or potent topical corticosteroid appears more effective than other topical agents, including vitamin D₃ analogues, for treating scalp psoriasis.
A topical anti-inflammatory glucocorticoid used in DERMATOSES, skin allergies, PSORIASIS, etc.
Human immune-response, D-related antigen encoded by the D locus on chromosome 6 and found on lymphoid cells. It is strongly associated with celiac disease and psoriasis vulgaris.
A topical dermatologic agent that is used in the treatment of ACNE VULGARIS and several other skin diseases. The drug has teratogenic and other adverse effects.
An iodinated polyvinyl polymer used as topical antiseptic in surgery and for skin and mucous membrane infections, also as aerosol. The iodine may be radiolabeled for research purposes.
A dry artificial sterile sponge of fibrin prepared by clotting with thrombin a foam or solution of fibrinogen. It is used in conjunction with thrombin as a hemostatic in surgery at sites where bleeding cannot be controlled by more common methods. (From Martindale, The Extra Pharmacopoeia, 30th ed, p648)
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...