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

Mild to Moderate Psoriasis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01587755
• Other study ID #: 055-006
• Status: Completed
• Phase: Phase 4
• First received: April 25, 2012
• Last updated: March 6, 2015
• Start date: March 2012
• Est. completion date: June 2014

Study information

• Verified date: March 2015
• Source: Reich, Kristian, M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-InstitutDenmark: Danish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Italy: The Italian Medicines AgencyNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Sweden: Medical Products AgencySpain: Agencia Española de Medicamentos y Productos SanitariosUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1852
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Mild to Moderate Psoriasis
• Psoriasis

Intervention

Other:
• TTOP
Patient is taken care of in an intensified, optimised manner
• non-TTOP
Standard medical care

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Kristian Reich, MD	LEO Pharma

Countries where clinical trial is conducted

Denmark,  France,  Germany,  Italy,  Netherlands,  Spain,  Sweden,  United Kingdom, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No