Optimising outpatient care in mild to moderate psoriasis by a newly developed *Topical Treatment Optimising Programme* - an international study using Daivobet®/Dovobet® Gel (*PSO-TOP*)
- Conditions
- plaque psoriasispsoriasis1000381610014982
- Registration Number
- NL-OMON37524
- Lead Sponsor
- SCIderm GmbH
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 70
- Male and female patients aged at least 18 years
- Mild to moderate active plaque psoriasis with a 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 / 0.5 mg 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®
- 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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Rate of patients with a PGA (as defined by Langley and Ellis 2004) of 0 or 1 at<br /><br>week 8.</p><br>
- Secondary Outcome Measures
Name Time Method <p>1) Rate of patients with a PGA (as defined by Langley and Ellis 2004) of 0 or 1<br /><br>at weeks 16 to 64 (documented at intervals of 8 weeks)<br /><br>2) Mean PGA and BSA at weeks 8 to 64 (documented at intervals of 8 weeks)<br /><br>3) EQ-5D, EQ-VAS and DLQI at weeks 0, 8, 32 and 64<br /><br>4) Rate of patients achieving DLQI * 5 at weeks 0, 8, 32 and 64<br /><br>5) Exploratory Patient Reported Outcomes: TTQ, PPQ and PsGA at weeks 0, 8, 32<br /><br>and 64<br /><br>6) Results of TTOP element ranking by the patient (only TTOP intervention arm)<br /><br>at weeks 8 and 64<br /><br>7) Rate of patients reaching a PsGA score of 0 or 1 at weeks 8 to 64 in the<br /><br>single countries (documented at intervals of 8 weeks)<br /><br>8) Days away from work/studies due to psoriasis<br /><br>9) Mean weight of returned study medication at weeks 4 to 64 (documented at<br /><br>intervals of 4 to 8 weeks)<br /><br>10) Drop-out rate per study arm at week 64<br /><br>11) Rates of AEs and SAEs</p><br>