Optimising Outpatient Care in Mild to Moderate Psoriasis (PSO-TOP) (PSO-TOP)

Optimising Outpatient Care in Mild to Moderate Psoriasis by a Newly Developed 'Topical Treatment Optimising Programme' - an International Study Using Daivobet®/Dovobet® Gel

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.

Study Overview

• Status: Completed
• Conditions: Mild to Moderate Psoriasis
• Intervention / Treatment: Other: TTOP; Other: non-TTOP

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.

• Study Type: Interventional
• Enrollment (Actual): 1852
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Herning, Denmark
  • Hobro, Denmark
  • Roskilde, Denmark
  • Vejle, Denmark
• France
  • Angers Cedex 9, France
  • Auxerre, France
  • Brest, France
  • Lille Cedex, France
  • Limeil Brevannes, France
  • Marseille Cedex 08, France
  • Martigues, France
  • Paris Cedex 10, France
  • Poitiers Cedex, France
  • Saint Mande, France
  • Saint Priest en Jarez, France
  • Saint-Germain en Laye, France
  • Tours Cedex 1, France
  • Vienne, France
• Germany
  • Bad Bentheim, Germany
  • Berlin, Germany
  • Biberach, Germany
  • Blaubeuren, Germany
  • Bochum, Germany
  • Buchholz, Germany
  • Dessau, Germany
  • Frankfurt, Germany
  • Friedrichshafen, Germany
  • Gilching, Germany
  • Hamburg, Germany
  • Hannover, Germany
  • Kiel, Germany
  • Köln, Germany
  • Mahlow, Germany
  • Osnabrück, Germany
  • Pinneberg, Germany
  • Selters, Germany
  • Weißenfels, Germany
  • Wolfenbüttel, Germany
  • Wuppertal, Germany
• Italy
  • Brescia, Italy
  • Catania, Italy
  • Genova, Italy
  • L'Aquila, Italy
  • Lucca, Italy
  • Messina, Italy
  • Padova, Italy
  • Palermo, Italy
  • Parma, Italy
  • Pavia, Italy
  • Perugia, Italy
  • Rome, Italy
  • Trapani, Italy
  • Verona, Italy
• Netherlands
  • Amsterdam, Netherlands
  • Geldrop, Netherlands
  • Maastricht, Netherlands
  • Nijmegen, Netherlands
  • Rotterdam, Netherlands
• Spain
  • Alicante, Spain
  • Barcelona, Spain
  • Barcelona,, Spain
  • Fuenlabrada (Madrid), Spain
  • Getafe (Madrid), Spain
  • Madrid, Spain
  • Palma de Mallorca, Spain
  • Tarragona, Spain
  • Valencia, Spain
  • Zaragoza, Spain
• Sweden
  • Eskilstuna, Sweden
  • Göteborg, Sweden
  • Kristianstad, Sweden
  • Linköping, Sweden
  • Uppsala, Sweden
  • Örebrö, Sweden
• United Kingdom
  • Bexhill, 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
  • Leamington Spa, United Kingdom
  • London, United Kingdom
  • Manchester, United Kingdom
  • Merseyside, United Kingdom
  • Middlesex, United Kingdom
  • Nantwich, United Kingdom
  • Nuneaton, United Kingdom
  • Oldham, United Kingdom
  • Tunbridge Wells, United Kingdom
  • Warwickshire, United Kingdom
  • West Sussex, United Kingdom

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Topical Treatment Optimizing Program; Optimized care	Other: TTOP; Patient is taken care of in an intensified, optimised manner
OTHER: non-Topical Treatment Optimizing Program; Standard care	Other: non-TTOP; Standard medical care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Kristian Reich, MD
• Collaborators: LEO Pharma
• Investigators: Principal Investigator: Kristian Reich, MD Prof.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (ACTUAL): June 1, 2014
• Study Completion (ACTUAL): June 1, 2014

Study Registration Dates

• First Submitted: April 25, 2012
• First Submitted That Met QC Criteria: April 26, 2012
• First Posted (ESTIMATE): April 30, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): March 9, 2015
• Last Update Submitted That Met QC Criteria: March 6, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: 055-006