optomising of a topical treatment in patients with mild to moderate psoriasis in an international study

• Conditions: Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]; PATIENTS WITH MILD TO MODERATE PSORIASIS; MedDRA version: 14.0Level: PTClassification code 10037153Term: PsoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders

• Registration Number: EUCTR2011-001697-26-IT
• Lead Sponsor: SCIDERM GMBH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-06
• Last Update Posted: 30 March 2015

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 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)
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 978
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 978

Exclusion Criteria

- Severe renal insufficiency - Severe hepatic disorders - Known disorders in calcium metabolism - 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 or breast-feeding women - Hypersensitivity to the active substances or to any of the excipients - Suspected non-compliance - Current participation in another clinical study - Systemic treatment of plaque psoriasis over the last 8 weeks prior to Visit 1 (week 0) - Phototherapy during the last 4 weeks prior to Visit 1 (week 0)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified