Mild to moderate active plaque psoriasis despite topical psoriasis treatment MedDRA version: 14.1 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Trade Name: Daivobet Gel
Pharmaceutical Form: Gel
INN or Proposed INN: Calcipotriol
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 0,05-
INN or Proposed INN
Sponsors
Professor Reich
Eligibility
Sex/Gender
All
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: To assess the value of the ‘Topical Treatment Optimising Programme’ in the topical treatment of insufficiently treated mild to moderate psoriasis after 8 weeks of once daily treatment with Daivobet® Gel. ;Secondary Objective: Secondary objectives: To assess the value of the ‘Topical Treatment Optimising Programme’ in the topical treatment of insufficiently treated mild to moderate psoriasis every 8 weeks over a treatment period of 64 weeks. To assess the usefulness of a ‘Topical Therapy Questionnaire’, a ‘Patient Preference Questionnaire’ and ‘Patient’s self Global Assessment’ in the assessment of patient reported outcomes and in comparison to available tools. To assess the value of the ‘Topical Treatment Optimising Programme’ in country-specific subanalyses. To compare the drop-out rates after 64 weeks of treatment between the study arms (‘Topical Treatment Optimising Programme’ versus ‘non- Topical Treatment Optimising Programme’). To compare the consumption of Daivobet® Gel between the study arms. To confirm long term efficacy and safety of the study medication. ;Primary end point(s): Rate of patients with a PGA (as defined by Langley and Ellis 2004) of 0 or 1 at week 8;Timepoint(s) of evaluation of this end point: week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Rate of patients with a PGA (as defined by Langley and Ellis 2004) of 0 or 1 at weeks 16 to 64 (documented at intervals of 8 weeks) Mean PGA and BSA at weeks 8 to 64 (documented at intervals of 8 weeks) EQ-5D, EQ-VAS and DLQI at weeks 0, 8, 32 and 64 Rate of patients achieving DLQI = 5 at weeks 0, 8, 32 and 64 Exploratory Patient Reported Outcomes: TTQ, PPQ and PsGA at weeks 0, 8, 32 and 64 Results of TTOP element ranking by the patient (only TTOP intervention arm) at weeks 8 and 64 Rate of patients reaching a PsGA score of 0 or 1 at weeks 8 to 64 in the single countries (documented at intervals of 8 weeks) Days away from work/studies due to psoriasis Mean weight of returned study medication at weeks 4 to 64 (documented at intervals of 4 to 8 weeks) Drop-out rate per study arm at week 64 Rates of AEs and SAEs ;Timepoint(s) of evaluation of this end point: Throughout the study from week 0 to week 64 | — |
Countries
Denmark, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom
Contacts
Public ContactInternational Project Management
SCIderm GmbH
Outcome results
None listed