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| Name | Class |
|---|---|
| LEO Pharma | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical Treatment Optimizing Program | Other | Optimized care |
|
| non-Topical Treatment Optimizing Program | Other | Standard care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TTOP | Other | Patient is taken care of in an intensified, optimised manner |
|
| 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 |
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Inclusion Criteria:
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):
Phototherapy within the following time periods prior to Visit 1 (week 0):
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| Name | Affiliation | Role |
|---|---|---|
| Kristian Reich, MD Prof. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herning | Denmark | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25346093 | Background | 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. | |
| 24895177 |
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| non-TTOP | Other | Standard medical care |
|
| 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 |
| Padova | 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 |
| Background |
| 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. |
| 24509981 | Background | 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. |
| 28301043 | Derived | 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. |