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’)

Phase 1

• Conditions: Mild to moderate active plaque psoriasis despite topical psoriasis treatment; MedDRA version: 14.1Level: LLTClassification code 10050576Term: Psoriasis vulgarisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2011-001697-26-DK
• Lead Sponsor: Professor Reich

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-06
• Last Update Posted: 8 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1956

Inclusion Criteria

- 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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®
- Pregnant and/or breast-feeding women or women of childbearing potential who do not agree to use one of the following contraceptive methods for the duration of the study and at least 1 week after the last dose of study medication: Intrauterine devices or hormonal contraceptives (contraceptive pills, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release)
- 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 clinical trial of medicinal product
• Study Design: Not specified