PSOREAL - Managing PSOriasis in the REAL World

Status Completed

Clinical Trial Summary

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).

Clinical Trial Description

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 400 real-life prescribers in 3-8 countries 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02935582
Study type	Observational
Source	LEO Pharma
Contact
Status	Completed
Phase
Start date	January 2017
Completion date	December 30, 2020

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03669757` - Clinical Trial to Assess Safety, Tolerability and the Pharmacodynamic Effect of Different Concentrations of a New Anti-inflammatory Substance in Subjects With Chronic Plaque Psoriasis	Phase 1
Completed	`NCT03614078` - A Study of PRCL-02 in Moderate to Severe Chronic Plaque Psoriasis	Phase 2
Completed	`NCT03584360` - Role of Topical Treatments in the Modulation of Skin Microbiome in Psoriatic Skin	Phase 2
Recruiting	`NCT04994951` - Pilot Study of Traditional Chinese Medicine (Qing-Re-Liang-Xue Decoction) as Complementary Medicine for Psoriasis Vulgaris of Blood-heat Syndrome.	Phase 2
Completed	`NCT02888236` - LEO 32731 for the Treatment of Moderate to Severe Psoriasis Vulgaris	Phase 2
Completed	`NCT02533973` - Long-term Treatment of Scalp Psoriasis With Xamiol® Gel in a Large Adult Chinese Population	Phase 4
Completed	`NCT02193815` - A 12 Day Study To Evaluate A Topical Drug To Treat Plaque Psoriasis	Phase 1
Completed	`NCT01946386` - A Vasoconstriction Study With LEO 90100	Phase 1
Completed	`NCT02004847` - Blue Light for Treating Psoriasis Vulgaris	N/A
Recruiting	`NCT01443338` - Study Evaluating the Efficacy and Safety of Triptergium Wilfordii and Acitretin in Psoriasis Vulgaris - CHINA201002016-2	Phase 4
Completed	`NCT01188928` - LEO 80185 in the Treatment of Psoriasis Vulgaris on the Non-scalp Regions of the Body (Trunk and/or Limbs)	Phase 3
Completed	`NCT00764751` - Efficacy and Safety of LEO 19123 Cream in the Treatment of Psoriasis Vulgaris	Phase 2
Completed	`NCT00236171` - Evaluation of Topical Antipsoriatics in the Psoriasis Plaque Test	N/A
Completed	`NCT04541329` - Predicting Inflammatory Skin Disease Response to IL-23 Blockade	Phase 4
Completed	`NCT06064084` - Incretin Effect in Patients With Psoriasis and Controls
Not yet recruiting	`NCT06398106` - Proactive TDM Versus Standard Use of Biologics in Psoriasis	Phase 4
Recruiting	`NCT05390515` - Psoriatic Immune Response to Tildrakizumab	Phase 4
Recruiting	`NCT05892640` - Low-Salt Diet Effect on Th17-Mediated Inflammation and Vascular Reactivity in Psoriasis	N/A
Recruiting	`NCT04950218` - The Psoriasis Echo Study
Completed	`NCT05184348` - Plexin B2 Gene Expression and Polymorphisms in Psoriasis	Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

PSOREAL - Managing PSOriasis in the REAL World — PSOREAL

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms