Efficacy and Safety of LEO 90100 Foam in Japanese Subjects With Psoriasis Vulgaris

A phase 3, national, multi-centre, 4-week, prospective, randomised, controlled, parallel-group, open trial of LEO 90100 foam versus Dovobet® ointment (both treatments containing calcipotriol hydrate plus betamethasone dipropionate) in Japanese subjects with psoriasis vulgaris.

Key Inclusion Criteria:

• Signed and dated informed consent obtained
• Japanese subjects
• Aged 20 years or above
• 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).
• 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.
• 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.
• Able to communicate with the (sub)investigator and understand and comply with the requirements of the trial.

Key Exclusion Criteria:

• Systemic use of biological treatments with a potential effect on psoriasis vulgaris within the specified time periods prior to randomisation (depending on treatment)
• Systemic treatments with all therapies other than biological treatments with a potential effect on psoriasis vulgaris within 4 weeks prior to randomisation
• PUVA therapy, UVB therapy or UVA therapy on the full body or on the target lesion within 4 weeks prior to randomisation
• Topical treatment of psoriasis on the areas to be treated with trial medication within 2 weeks prior to randomisation
• 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
• Topical treatment of conditions other than psoriasis with vitamin D3 analogues, potent corticosteroids or immunosuppressants within 2 weeks prior to randomisation
• Initiation or changes of medication that may affect psoriasis vulgaris during the trial
• 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
• Other inflammatory skin diseases that may confound the evaluation of psoriasis vulgaris
• Erythrodermic, exfoliative or pustular psoriasis on the areas to be treated with trial medication
• Planned excessive exposure of areas to be treated with trial medication to either natural or artificial sunlight during the trial.
• Disorders of calcium metabolism
• Severe renal insufficiency, severe hepatic disorders or severe heart disease
• Hypersensitivity to any components of the investigational medicinal products.
• Cushing's disease or Addison's disease
• 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
• History of cancer within the last 5 years (except completely cured skin cancer)
• Current participation in any other interventional clinical trial
• Previously randomised in this trial
• Women who are pregnant, wishing to become pregnant or are breast-feeding
• Chronic alcohol or drug abuse within 12 months prior to screening, or any condition associated with poor compliance
• 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