psoriasis vulgaris MedDRA version: 12.1 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris
Conditions
Interventions
Product Name: LEO 90110 ointment
Product Code: LEO 90110 ointment
Pharmaceutical Form: Ointment
CAS Number: 1035572-38-3
Current Sponsor code: LEO 29102
Concentration unit: mg/g milligram(s)/gram
Conc
Sponsors
LEO Pharma A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Following verbal and written information about the trial, the subject has provided signed and dated in-formed consent before any study related activity is carried out, including activities relating to the wash-out period 2. Clinical diagnosis of psoriasis vulgaris with lesions located on arms, legs or trunk amenable for topical treatment 3. Two symmetrically distributed lesions, one on each side of the body, located on arms, legs or trunk, fulfilling the following criteria: a. Size Each lesion of minimum 0.5% and maximum 1% of total body surface area. The two lesions should be of similar size according to the Investigator’s judge-ment. b. Total Clinical Score Each lesion with a Total Clinical Score of at least 5. Any difference in Total Clinical Score between the two lesions should be of maximum ‘1’. c. Severity Severity of each lesion at least mild according to Investigator’s Global Assessment. Severity score must be the same for both lesions. 4. Aged 18 years or above 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. Systemic treatment with biological therapies directed against or with a potential effect on psoriasis vulgaris, within the following time period: - etanercept: within 4 weeks prior to randomisation - adalimumab, infliximab: within 2 months prior to randomisation - alefacept, ustekinumab: within 4 months prior to randomisation 2. Systemic treatment with all other than biological therapies with a potential effect on psoriasis vulgaris (e.g. corticosteroids, retinoids, immunosuppressants, salazopyrin) within 4 weeks prior to randomisation 3. PUVA therapy or Grenz ray therapy within 4 weeks prior to randomisation 4. UVB therapy within 2 weeks prior to randomisation 5. Topical treatment with potent or very potent WHO group III and IV corticosteroids within 2 weeks prior to randomisation 6. Any topical treatment (except for emollients) of the two selected target lesions within 2 weeks prior to randomisation 7. Planned initiation of, or planned changes to, concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, chloroquine, lithium and ACE inhibitors) within 2 weeks prior to randomisation and during the study 8. Treatment with drugs sensitive to CYP3A4 or CYP2D6 metabolism within 5 half lives prior to randomisation 9. Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis 10. Any of the following conditions present on the two selected target lesions: Infectious skin disorder, eczematous skin, atopic dermatitis, ulcers or wounds 11. Skin disease on the two selected target lesions that may confound the evaluation of psoriasis vulgaris (e.g., seborrhoiec dermatitis, contact dermatitis or fungal infection) as judged by the Investigator 12. Planned exposure to the sun during the study that may affect psoriasis vulgaris (i.e., normal lifestyle outdoor activities are permitted but deliberate exposure to sunlight or artificial ultraviolet light to the two selected target lesions should be avoided) 13. Clinically significant cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, haematologic, malignant or gastrointestinal disease, immunologic insufficiency, or other major diseases or current condition which, in the opinion of the Investigator, would put the subject at risk by participating in the study or would interfere with the evaluation of study results 14. History of immune deficiency condition (e.g., lymphoma, HIV or Wiskott-Aldrich Syndrome) 15. Chronic or ongoing infectious disease requiring systemic treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis, active hepatitis B, active hepatitis C, HIV positive 16. Known or suspected hypersensitivity to component( s) of the investigational products 17. Current participation in any other interventional clinical trial 18. Treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registration) within the last 4 weeks prior to randomisation, or for biologics, within the last 12 weeks prior to randomisation 19. Previously randomised in this trial 20. Known or suspected to be unlikely to comply with the Clinical Study Protocol (e.g., due to alcoholism, drug dependency or psychotic state) 21. Female subjects who are pregnant, of child-bearing potential and wishing to become pregnant during the trial, or are breast feeding 22. Female subjects of childbearing potential1 expected not using an adequate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare LEO 90110 20.0 mg/g ointment to LEO 90110 ointment vehicle with respect to efficacy when administered twice daily for 8 weeks to patients with psoriasis vulgaris ;Secondary Objective: To compare LEO 29102 2.5 mg/g cream to LEO 29102 cream vehicle with respect to efficacy when administered twice daily for 8 weeks to patients with psoriasis vulgaris To compare LEO 90110 20.0 mg/g ointment to LEO 29102 2.5 mg/g cream with respect to efficacy when administered twice daily for 8 weeks to patients with psoriasis vulgaris To investigate the safety of LEO 90110 20.0 mg/g ointment and LEO 29102 2.5 mg/g cream when administered twice daily for 8 weeks to patients with psoriasis vulgaris ;Primary end point(s): The absolute change in Total Clinical Score from baseline (Visit 1) to 8 weeks of treatment (end of treatment, Visit 7) for the selected target lesion on the left and right side of the body | — |
Countries
Germany
Outcome results
None listed