Optimising Outpatient Care in Mild to Moderate Psoriasis (PSO-TOP)
PSO-TOP
1 other identifier
interventional
1,852
8 countries
93
Brief Summary
A Topical Treatment Optimisation Programme (TTOP) has been developed by the sponsor together with Patient Boards and an Expert Advisory Board to overcome non-adherence problems.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2012
Typical duration for phase_4
93 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 25, 2012
CompletedFirst Posted
Study publicly available on registry
April 30, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedMarch 9, 2015
March 1, 2015
2.3 years
April 25, 2012
March 6, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Physician Global Assessment (PGA)
PGA (Physician Global Assessment) will be assessed at all study visits. For week 8, the rate of patients with a PGA (as defined by Langley and Ellis 2004) of 0 or 1 will be calculated. This is the primary study parameter.
Up to 64 weeks; primary outcome assessed at week 8 after treatment start
Study Arms (2)
Topical Treatment Optimizing Program
OTHEROptimized care
non-Topical Treatment Optimizing Program
OTHERStandard care
Interventions
Eligibility Criteria
You may qualify if:
- Male and female patients aged at least 18 years
- Mild to moderate active plaque psoriasis with PGA ≥ 2 on the 7-point scale by Langley and Ellis and a Body Surface Area (BSA) of ≤ 10%
- Topical psoriasis treatment with coal or tar preparations, tazarotene, steroids, or vitamin D analogues, or combinations of steroids and vitamin D analogues (except gel combination products containing 50 micrograms calcipotriol/0.5mg betamethasone/g) or dithranol and its combination preparations over the last 8 weeks prior to Visit 1 (week 0)
- Written informed consent to participate in the study has been given prior to any study related procedures
You may not qualify if:
- Severe renal insufficiency
- Severe hepatic disorders
- Known hyper calcaemia
- Erythrodermic, exfoliative, pustular or guttate psoriasis
- Facial or genital psoriasis
- Fulfilment of at least one contraindication according to the Summary of Product Characteristics of Daivobet®/Dovobet® Gel
- Pregnant and/or breast-feeding women
- Hypersensitivity to the active substances or to any of the excipients
- Suspected non-compliance with the clinical study procedures
- Current participation in another clinical study
- Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to Visit 1 (week 0):
- etanercept - within 4 weeks prior to Visit 1 (week 0)
- adalimumab, alefacept, infliximab - within 2 months prior to Visit 1 (week 0)
- ustekinumab - within 4 months prior to Visit 1 (week 0)
- experimental products - within 4 weeks/5 half-lives (whichever is longer) prior to Visit 1 (week 0)
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kristian Reich, MDlead
- LEO Pharmacollaborator
Study Sites (93)
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Herning, Denmark
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Hobro, Denmark
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Roskilde, Denmark
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Vejle, Denmark
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Angers, France
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Auxerre, France
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Brest, France
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Lille, France
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Limeil-Brévannes, France
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Marseille, France
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Martigues, France
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Paris, France
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Poitiers, France
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Saint-Germain-en-Laye, France
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Saint-Mandé, France
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Saint-Priest-en-Jarez, France
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Tours, France
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Vienne, France
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Bad Bentheim, Germany
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Berlin, Germany
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Biberach, Germany
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Blaubeuren Abbey, Germany
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Bochum, Germany
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Buchholz, Germany
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Cologne, Germany
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Dessau, Germany
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Frankfurt, Germany
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Friedrichshafen, Germany
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Gilching, Germany
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Hamburg, Germany
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Hanover, Germany
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Kiel, Germany
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Mahlow, Germany
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Osnabrück, Germany
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Pinneberg, Germany
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Selters, Germany
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Weißenfels, Germany
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Wolfenbüttel, Germany
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Wuppertal, Germany
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Brescia, Italy
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Catania, Italy
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Genova, Italy
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Lucca, Italy
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L’Aquila, Italy
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Messina, Italy
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Padua, Italy
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Palermo, Italy
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Parma, Italy
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Pavia, Italy
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Perugia, Italy
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Rome, Italy
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Trapani, Italy
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Verona, Italy
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Amsterdam, Netherlands
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Geldrop, Netherlands
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Maastricht, Netherlands
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Nijmegen, Netherlands
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Rotterdam, Netherlands
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Alicante, Spain
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Barcelona, Spain
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Fuenlabrada (Madrid), Spain
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Getafe (Madrid), Spain
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Madrid, Spain
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Palma de Mallorca, Spain
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Tarragona, Spain
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Valencia, Spain
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Zaragoza, Spain
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Eskilstuna, Sweden
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Gothenburg, Sweden
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Kristianstad, Sweden
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Linköping, Sweden
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Örebrö, Sweden
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Uppsala, Sweden
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Bexhill-on-Sea, United Kingdom
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Bradford, United Kingdom
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Burbage, United Kingdom
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Canterbury, United Kingdom
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Cheshire, United Kingdom
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Chesterfield, United Kingdom
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Coventry, United Kingdom
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Darwen, United Kingdom
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East Sussex, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
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Merseyside, United Kingdom
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Middlesex, United Kingdom
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Nantwich, United Kingdom
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Nuneaton, United Kingdom
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Oldham, United Kingdom
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Royal Leamington Spa, United Kingdom
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Royal Tunbridge Wells, United Kingdom
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Warwickshire, United Kingdom
Unknown Facility
West Sussex, United Kingdom
Related Publications (4)
Reich K, Zschocke I, Bachelez H, de Jong EM, Gisondi P, Puig L, Warren RB, Mrowietz U; TTOP study group. Efficacy of a fixed combination of calcipotriol/betamethasone dipropionate topical gel in adult patients with mild to moderate psoriasis: blinded interim analysis of a phase IV, multicenter, randomized, controlled, prospective study. J Eur Acad Dermatol Venereol. 2015 Jun;29(6):1156-63. doi: 10.1111/jdv.12774. Epub 2014 Oct 26.
PMID: 25346093BACKGROUNDReich K, Mrowietz U, Karakasili E, Zschocke I. Development of an adherence-enhancing intervention in topical treatment termed the topical treatment optimization program (TTOP). Arch Dermatol Res. 2014 Sep;306(7):667-76. doi: 10.1007/s00403-014-1475-5. Epub 2014 Jun 4.
PMID: 24895177BACKGROUNDZschocke I, Mrowietz U, Lotzin A, Karakasili E, Reich K. Assessing adherence factors in patients under topical treatment: development of the Topical Therapy Adherence Questionnaire (TTAQ). Arch Dermatol Res. 2014 Apr;306(3):287-97. doi: 10.1007/s00403-014-1446-x. Epub 2014 Feb 8.
PMID: 24509981BACKGROUNDReich K, Zschocke I, Bachelez H, de Jong EMGJ, Gisondi P, Puig L, Warren RB, Ortland C, Mrowietz U; PSO-TOP study group. A Topical Treatment Optimization Programme (TTOP) improves clinical outcome for calcipotriol/betamethasone gel in psoriasis: results of a 64-week multinational randomized phase IV study in 1790 patients (PSO-TOP). Br J Dermatol. 2017 Jul;177(1):197-205. doi: 10.1111/bjd.15466. Epub 2017 Jun 6.
PMID: 28301043DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Kristian Reich, MD Prof.
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDIV
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Kristian Reich, MD
Study Record Dates
First Submitted
April 25, 2012
First Posted
April 30, 2012
Study Start
March 1, 2012
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
March 9, 2015
Record last verified: 2015-03