Optimising Outpatient Care in Mild to Moderate Psoriasis (PSO-TOP)
NCT ID: NCT01587755
Last Updated: 2015-03-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
1852 participants
INTERVENTIONAL
2012-03-31
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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Topical Treatment Optimizing Program
Optimized care
TTOP
Patient is taken care of in an intensified, optimised manner
non-Topical Treatment Optimizing Program
Standard care
non-TTOP
Standard medical care
Interventions
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TTOP
Patient is taken care of in an intensified, optimised manner
non-TTOP
Standard medical care
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
* Phototherapy within the following time periods prior to Visit 1 (week 0):
* PUVA - within 4 weeks prior to Visit 1 (week 0)
* UV-B - within 2 weeks prior to Visit 1 (week 0)
18 Years
ALL
No
Sponsors
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LEO Pharma
INDUSTRY
Kristian Reich, MD
INDIV
Responsible Party
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Kristian Reich, MD
Kristian Reich, MD
Principal Investigators
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Kristian Reich, MD Prof.
Role: PRINCIPAL_INVESTIGATOR
Locations
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Herning, , Denmark
Hobro, , Denmark
Roskilde, , Denmark
Vejle, , Denmark
Angers, , France
Auxerre, , France
Brest, , France
Lille, , France
Limeil-Brévannes, , France
Marseille, , France
Martigues, , France
Paris, , France
Poitiers, , France
Saint-Germain-en-Laye, , France
Saint-Mandé, , France
Saint-Priest-en-Jarez, , France
Tours, , France
Vienne, , France
Bad Bentheim, , Germany
Berlin, , Germany
Biberach, , Germany
Blaubeuren Abbey, , Germany
Bochum, , Germany
Buchholz, , Germany
Cologne, , Germany
Dessau, , Germany
Frankfurt, , Germany
Friedrichshafen, , Germany
Gilching, , Germany
Hamburg, , Germany
Hanover, , Germany
Kiel, , Germany
Mahlow, , Germany
Osnabrück, , Germany
Pinneberg, , Germany
Selters, , Germany
Weißenfels, , Germany
Wolfenbüttel, , Germany
Wuppertal, , Germany
Brescia, , Italy
Catania, , Italy
Genova, , Italy
Lucca, , Italy
L’Aquila, , Italy
Messina, , Italy
Padua, , Italy
Palermo, , Italy
Parma, , Italy
Pavia, , Italy
Perugia, , Italy
Rome, , Italy
Trapani, , Italy
Verona, , Italy
Amsterdam, , Netherlands
Geldrop, , Netherlands
Maastricht, , Netherlands
Nijmegen, , Netherlands
Rotterdam, , Netherlands
Alicante, , Spain
Barcelona, , Spain
Fuenlabrada (Madrid), , Spain
Getafe (Madrid), , Spain
Madrid, , Spain
Palma de Mallorca, , Spain
Tarragona, , Spain
Valencia, , Spain
Zaragoza, , Spain
Eskilstuna, , Sweden
Gothenburg, , Sweden
Kristianstad, , Sweden
Linköping, , Sweden
Örebrö, , Sweden
Uppsala, , Sweden
Bexhill-on-Sea, , United Kingdom
Bradford, , United Kingdom
Burbage, , United Kingdom
Canterbury, , United Kingdom
Cheshire, , United Kingdom
Chesterfield, , United Kingdom
Coventry, , United Kingdom
Darwen, , United Kingdom
East Sussex, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Merseyside, , United Kingdom
Middlesex, , United Kingdom
Nantwich, , United Kingdom
Nuneaton, , United Kingdom
Oldham, , United Kingdom
Royal Leamington Spa, , United Kingdom
Royal Tunbridge Wells, , United Kingdom
Warwickshire, , United Kingdom
West Sussex, , United Kingdom
Countries
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References
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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.
Reich 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.
Zschocke 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.
Reich 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.
Other Identifiers
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055-006
Identifier Type: -
Identifier Source: org_study_id
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