Optimising Outpatient Care in Mild to Moderate Psoriasis (PSO-TOP)
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Kristian Reich, MD, Reich, Kristian, M.D.
First received: April 25, 2012
Last updated: April 10, 2013
Last verified: April 2013
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.
Mild to Moderate Psoriasis
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
||Optimising Outpatient Care in Mild to Moderate Psoriasis by a Newly Developed 'Topical Treatment Optimising Programme' - an International Study Using Daivobet®/Dovobet® Gel
Primary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2013 (Final data collection date for primary outcome measure)
Topical Treatment Optimizing Program
Patient is taken care of in an intensified, optimised manner
non-Topical Treatment Optimizing Program
Standard medical care
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01587755
Kristian Reich, MD
||Kristian Reich, MD Prof.
No publications provided
||Kristian Reich, MD, Reich, Kristian, M.D.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 25, 2012
||April 10, 2013
Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Italy: The Italian Medicines Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Sweden: Medical Products Agency
Spain: Agencia Española de Medicamentos y Productos Sanitarios
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 19, 2014
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