Psoriasis vulgaris on the trunk and/or limbs MedDRA version: 6.1 Level: LLT Classification code 10050576
Conditions
Interventions
Product Name: Daivobet Gel
Pharmaceutical Form: Gel
INN or Proposed INN: Betamethasone dipropionate
CAS Number: 5593-20-4
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentra
Sponsors
LEO Pharma A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed and dated informed consent has been obtained. 2. Clinical diagnoses of psoriasis vulgaris involving trunk and/or arms and/or legs amenable to treatment with a maximum of 100 g of topical medication per week. 3. An investigators’ global assessment of disease severity of at least mild. 4. Aged 18 years or above. 5. Either sex. 6. Any ethnic origin. 7. Attending hospital outpatient clinic or the private practice of a dermatologist. 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: 1. PUVA or Grenz ray therapy within 4 weeks prior to randomisation. 2. UVB therapy within 2 weeks prior to randomisation. 3. Systemic treatment with biological therapies (marketed or not marketed), with a possible effect on psoriasis vulgaris (e.g., alefacept, efalizumab, etanercept, infliximab) within 6 months prior to randomisation. 4. Systemic treatment with all other therapies than biologicals, with a possible effect on psoriasis vulgaris (e.g., corticosteroids, vitamin D analogues, retinoids, immunosuppres-sants) within 4 weeks prior to randomisation. 5. Any topical treatment of the trunk/limbs (except for emollients) within 2 weeks prior to randomisation. 6. Topical treatment for other relevant skin disorders (e.g., face psoriasis, scalp psoriasis, flexural psoriasis, eczema) within 2 weeks prior to randomisation. However, the following therapy is allowed on the face, scalp and flexures but not on the trunk and limbs within 2 weeks prior to randomisation: WHO group I-II corticosteroids, tar, reti-noid or dithranol products. 7. Planned initiation of, or changes to concomitant medication that could affect psoriasis vulgaris (e.g., beta blockers, anti-malaria drugs, lithium) during the study. 8. Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis. 9. Patients with any of the following conditions present on the treatment area: Viral lesions, fungal and bacterial skin infections, parasitic infections and atrophic skin. 10. Known or suspected abnormality of calcium homeostasis known to be associated with clinically significant hypercalcaemia. 11. Planned exposure to sun during the study that may affect the psoriasis vulgaris. 12. Known or suspected hypersentivity to component(s) of the Investigational Products. 13. Current participation in any other interventional study. 14. Patients who have received treatment with any non-marketed drug substance (i.e.,an agent which has not yet been made available for clinical use following registration) within a month prior to randomisation. 15. Previously randomised in this study. 16. Patients known or, in the opinion of the investigator, is unlikely to comply with the Clinical Study Protocol (e.g., due to alcoholism, drug dependence or psychotic state) 17. Females who are pregnant, or of child-bearing potential and wishing to become pregnant during the study, or are breast-feeding. 18. Females of child-bearing potential with positive pregnancy test at Visit 1. All females of child-bearing potential must have a pregnancy test at Visit 1. 19. Trial subjects not using an adequate method of contraception during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the clinical efficacy of once daily treatment for up to 8 weeks of calcipotriol plus betamethasone dipropionate gel with betamethasone dipropionate in the gel vehicle, cal-cipotriol in the gel vehicle and the gel vehicle alone in patients with psoriasis vulgaris on the trunk and/or limbs.;Secondary Objective: To compare the safety of once daily treatment for up to 8 weeks of calcipotriol plus be-tamethasone dipropionate gel with betamethasone dipropionate in the gel vehicle, calcipotriol in the gel vehicle and the gel vehicle alone in patients with psoriasis vulgaris. ;Primary end point(s): • Patients with “controlled disease” according to the investigators’ global assessment of disease severity (see definition below) at week 8. • Patients with “controlled disease” according to the investigators’ global assessment of disease severity (see definition below) at week 4. Definition: For patients with moderate disease or worse according to the investigator’s global assess-ment of disease severity at baseline, “controlled disease” is achieved when the disease is defined as “Minimal” or “Clear” by the investigator. For patients with mild disease at baseline, “controlled disease” is achieved when the investigator describes the disease as “Clear”. | — |
Countries
Germany, Ireland, Sweden, United Kingdom
Outcome results
None listed