Efficacy and Safety of LEO 90100 Foam in Japanese Subjects With Psoriasis Vulgaris
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Intervention: LEO 90100 foam; Dovobet® ointment
Intervention description: Once daily topical application of foam from a can to psoriasis lesions. Dose depends on size of lesion.; Once daily topical application of ointment from a tube to psoriasis lesions. Dose depends on size of lesion.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 182.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      Comparison of the efficacy of LEO 90100 foam with Dovobet® ointment in the treatment of
      psoriasis in Japanese subjects.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Signed and dated informed consent obtained

          2. Japanese subjects

          3. Aged 20 years or above

          4. Clinical diagnosis of psoriasis vulgaris amenable to topical treatment of less than or
             equal to 30% BSA (excluding psoriasis on the face/genitals/skin folds).

          5. A target psoriasis lesion of at least mild severity on the body of a minimum size of
             10 cm2 and scoring at least 2 (mild) for each of the clinical signs). The lesion must
             not be on the scalp, face, genitals or skin folds.

          6. Women of childbearing potential must have a negative pregnancy test at Day 1 and agree
             to use an adequate methods of birth control during the trial.

          7. Able to communicate with the (sub)investigator and understand and comply with the
             requirements of the trial.

        Key Exclusion Criteria:

          1. Systemic use of biological treatments with a potential effect on psoriasis vulgaris
             within the specified time periods prior to randomisation (depending on treatment)

          2. Systemic treatments with all therapies other than biological treatments with a
             potential effect on psoriasis vulgaris within 4 weeks prior to randomisation

          3. PUVA therapy, UVB therapy or UVA therapy on the full body or on the target lesion
             within 4 weeks prior to randomisation

          4. Topical treatment of psoriasis on the areas to be treated with trial medication within
             2 weeks prior to randomisation

          5. Topical treatment of psoriasis on the face, genitals or skin folds with vitamin D3
             analogues, potent corticosteroids or immunosuppressants within 2 weeks prior to
             randomisation

          6. Topical treatment of conditions other than psoriasis with vitamin D3 analogues, potent
             corticosteroids or immunosuppressants within 2 weeks prior to randomisation

          7. Initiation or changes of medication that may affect psoriasis vulgaris during the
             trial

          8. Patients with certain disorders or symptoms present on the areas to be treated with
             trial medication: viral lesions of the skin, infections, skin manifestations, or
             fragility of skin veins

          9. Other inflammatory skin diseases that may confound the evaluation of psoriasis
             vulgaris

         10. Erythrodermic, exfoliative or pustular psoriasis on the areas to be treated with trial
             medication

         11. Planned excessive exposure of areas to be treated with trial medication to either
             natural or artificial sunlight during the trial.

         12. Disorders of calcium metabolism

         13. Severe renal insufficiency, severe hepatic disorders or severe heart disease

         14. Hypersensitivity to any components of the investigational medicinal products.

         15. Cushing's disease or Addison's disease

         16. Subjects who have received treatment with any non-marketed drug substance within the 4
             weeks prior to randomisation, or longer if for certain biological treatments

         17. History of cancer within the last 5 years (except completely cured skin cancer)

         18. Current participation in any other interventional clinical trial

         19. Previously randomised in this trial

         20. Women who are pregnant, wishing to become pregnant or are breast-feeding

         21. Chronic alcohol or drug abuse within 12 months prior to screening, or any condition
             associated with poor compliance

         22. Employees of the trial site or any other individuals directly involved with the
             planning or conduct of the trial, or immediate family members of such individuals