Clinical trial NCT01587755: Optimising Outpatient Care in Mild to Moderate Psoriasis (PSO-TOP)
Official title: Optimising Outpatient Care in Mild to Moderate Psoriasis by a Newly Developed 'Topical Treatment Optimising Programme' - an International Study Using Daivobet®/Dovobet® Gel
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Mild to Moderate Psoriasis
Lead sponsor: Reich, Kristian, M.D.
Sponsor class: INDIV
Collaborators: name: LEO Pharma
First posted: 2012-04-30
Enrollment: 1852
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Detailed description: A Topical Treatment Optimisation Programme (TTOP) has been developed by the sponsor together with Patient Boards and an Expert Advisory Board. This tool is created to address patients' non-adherence in topical therapy and the resulting underperformance of such treatments in controlling psoriatic disease. The study addresses the effect of the relationship between the patient and the health care professional, one of the important factors that can affect treatment adherence and therapeutic efficacy. The TTOP will be compared to standardised regular care (called 'non-TTOP'). It is intended to clinically show the importance of an optimised contact between the patient and health care professional.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)
* 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)

Primary outcomes:
measure: Physician Global Assessment (PGA)
timeFrame: Up to 64 weeks; primary outcome assessed at week 8 after treatment start
Secondary outcomes:
Other outcomes:
Locations:
city: Herning
country: Denmark
city: Hobro
country: Denmark
city: Roskilde
country: Denmark
city: Vejle
country: Denmark
city: Angers Cedex 9
country: France
city: Auxerre
country: France
city: Brest
country: France
city: Lille Cedex
country: France
city: Limeil Brevannes
country: France
city: Marseille Cedex 08
country: France
city: Martigues
country: France
city: Paris Cedex 10
country: France
city: Poitiers Cedex
country: France
city: Saint Mande
country: France
city: Saint Priest en Jarez
country: France
city: Saint-Germain en Laye
country: France
city: Tours Cedex 1
country: France
city: Vienne
country: France
city: Bad Bentheim
country: Germany
city: Berlin
country: Germany
city: Biberach
country: Germany
city: Blaubeuren
country: Germany
city: Bochum
country: Germany
city: Buchholz
country: Germany
city: Dessau
country: Germany
city: Frankfurt
country: Germany
city: Friedrichshafen
country: Germany
city: Gilching
country: Germany
city: Hamburg
country: Germany
city: Hannover
country: Germany
city: Kiel
country: Germany
city: Köln
country: Germany
city: Mahlow
country: Germany
city: Osnabrück
country: Germany
city: Pinneberg
country: Germany
city: Selters
country: Germany
city: Weißenfels
country: Germany
city: Wolfenbüttel
country: Germany
city: Wuppertal
country: Germany
city: Brescia
country: Italy
city: Catania
country: Italy
city: Genova
country: Italy
city: L'Aquila
country: Italy
city: Lucca
country: Italy
city: Messina
country: Italy
city: Padova
country: Italy
city: Palermo
country: Italy
city: Parma
country: Italy
city: Pavia
country: Italy
city: Perugia
country: Italy
city: Rome
country: Italy
city: Trapani
country: Italy
city: Verona
country: Italy
city: Amsterdam
country: Netherlands
city: Geldrop
country: Netherlands
city: Maastricht
country: Netherlands
city: Nijmegen
country: Netherlands
city: Rotterdam
country: Netherlands
city: Alicante
country: Spain
city: Barcelona,
country: Spain
city: Barcelona
country: Spain
city: Fuenlabrada (Madrid)
country: Spain
city: Getafe (Madrid)
country: Spain
city: Madrid
country: Spain
city: Palma de Mallorca
country: Spain
city: Tarragona
country: Spain
city: Valencia
country: Spain
city: Zaragoza
country: Spain
city: Eskilstuna
country: Sweden
city: Göteborg
country: Sweden
city: Kristianstad
country: Sweden
city: Linköping
country: Sweden
city: Uppsala
country: Sweden
city: Örebrö
country: Sweden
city: Bexhill
country: United Kingdom
city: Bradford
country: United Kingdom
city: Burbage
country: United Kingdom
city: Canterbury
country: United Kingdom
city: Cheshire
country: United Kingdom
city: Chesterfield
country: United Kingdom
city: Coventry
country: United Kingdom
city: Darwen
country: United Kingdom
city: East Sussex
country: United Kingdom
city: Leamington Spa
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
city: Merseyside
country: United Kingdom
city: Middlesex
country: United Kingdom
city: Nantwich
country: United Kingdom
city: Nuneaton
country: United Kingdom
city: Oldham
country: United Kingdom
city: Tunbridge Wells
country: United Kingdom
city: Warwickshire
country: United Kingdom
city: West Sussex
country: United Kingdom
Study officials:
name: Kristian Reich, MD Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.