LEO 90105 Ointment in Japanese Subjects With Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: LEO 90105 = calcipotriol + betamethasone dipropionate; Dovonex® = calcipotriol; Rinderon® - DP = betamethasone dipropionate
Intervention description: Applied once daily for 4 weeks.; Applied twice daily for 4 weeks.; Applied once daily for 4 weeks.
Intervention MeSH terms: Calcitriol; Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Calcipotriene; Betamethasone sodium phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 676.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: A national; multi-centre; prospective; randomised; double-blind; active-controlled; 3-arm; parallel group; 4 week study

Summary:

      The purpose of this study is to compare the efficacy of LEO 90105 ointment applied once daily
      with Dovonex® ointment applied twice daily and with Rinderon®-DP ointment applied once daily
      in Japanese subjects with psoriasis vulgaris.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects having understood and signed a written informed consent form prior to any
             study related procedures being carried out.

          -  Japanese subjects.

          -  20 years of age or above.

          -  Either sex.

          -  Clinical diagnosis of psoriasis vulgaris amenable to topical treatment, involving arms
             and/or trunk and/or legs.

          -  A minimum m-PASI (Modified Psoriasis Area and Severity Index) score for extent of 2 in
             at least one body region (i.e.

        psoriasis affecting at least 10% of arms, and/or 10% of trunk, and/or 10% of legs).

          -  Psoriasis vulgaris on the trunk/limbs (excluding psoriasis on the genitals/skin folds)
             of not more than 30% body surface area (BSA).

          -  A target lesion of a minimum of 5 cm at its longest axis and preferably not located on
             an elbow or knee, scoring at least 3 for each of redness, thickness and scaliness, and
             at least 10 in total by the physician's assessment of severity of the target lesion -
             A physician's global assessment of disease severity of psoriasis on trunk/limbs of
             mild, moderate, severe or very severe.

          -  Females of childbearing potential must have a negative result for a urine pregnancy
             test at Day 0 (Visit 1) and must agree to use an adequate method of birth control, as
             judged by the (sub)investigator, during the study. The contraceptive method should
             have started an adequate amount of time before the pregnancy test, which is dependent
             on the partic-ular method used and as judged by the (sub)investigator, and must
             continue for at least 1 week after the last application of study medication. A female
             is defined as not of child-bearing potential if she is postmenopausal (12 months with
             no menses without an alter-native medical cause) or surgically sterile (tubal
             ligation/section, hysterectomy or bilateral ovariectomy).

        Exclusion Criteria:

          -  Systemic use of biological treatments with a potential effect on psoriasis vulgaris
             within the following time periods prior to randomisation:

          -  etanercept, adalimumab, infliximab - 3 months

          -  ustekinumab - 4 months

          -  other products - 3 months/5 half-lives (whichever is longer).

          -  Systemic treatments with all therapies other than biological treatments with a
             potential effect on psoriasis vulgaris (e.g., corticosteroids, vitamin D analogues,
             retinoids, immu-nosuppressants such as ciclosporin and methotrexate) within 4 weeks
             prior to randomi-sation (use of inhaled and nasal corticosteroids is allowed, use of
             systemic antihistamines is allowed).

          -  Psoralen plus ultraviolet light A (PUVA) therapy, ultraviolet light B (UVB) therapy or
             ultraviolet light A (UVA) therapy within 4 weeks prior to randomisation.

          -  Topical treatment of psoriasis on area(s) to be treated with study medication within 2
             weeks prior to randomisation (use of emollients is allowed during this 2-week period,
             but not after randomisation).

          -  Topical treatment of psoriasis on the face, genitals or skin folds with vitamin D
             ana-logues (e.g. calcipotriol, tacalcitol, maxacalcitol), or potent or very potent
             World Health Organisation (WHO) group III or IV corticosteroids within 2 weeks prior
             to randomisation.

          -  Topical treatment of scalp psoriasis with vitamin D analogues (e.g. calcipotriol,
             tacalcitol, maxacalcitol), or very potent WHO group IV corticosteroids within 2 weeks
             prior to randomisation.

          -  Topical treatment of conditions other than psoriasis with vitamin D analogues (e.g.
             calcipotriol, tacalcitol, maxacalcitol), or potent or very potent WHO group III or IV
             cor-ticosteroids within 2 weeks prior to randomisation.

          -  Planned initiation of, or changes in, concomitant medication that may affect psoriasis
             vulgaris (e.g., beta-blockers, antimalaria drugs, lithium and Angiotensin Converting
             Enzyme (ACE) inhibitors) during the study.

          -  Current diagnosis of erythrodermic, exfoliative, guttate or pustular psoriasis.

          -  Patients with any of the following disorders (a) or symptoms (b) present on the
             area(s) to be treated with study medication: (a) viral (e.g., herpes or varicella)
             lesions of the skin, fungal or bacterial skin infections, parasitic infections, skin
             manifestations in relation to syphilis or tuberculosis, rosacea, acne vulgaris,
             atrophic skin, striae atrophicae, ichthyosis, acne rosacea, ulcers, burns, frostbite,
             wounds, or (b) fragility of skin veins..

          -  Other inflammatory skin diseases (e.g., seborrhoeic dermatitis, contact dermatitis and
             cutaneous mycosis) that may confound the evaluation of psoriasis vulgaris on the
             trunk/limbs.

          -  Planned excessive exposure of area(s) to be treated with study medication to either
             natural or artificial sunlight (including tanning booths, sun lamps, etc) during the
             study.

          -  Known or suspected disorders of calcium metabolism associated with hypercalcaemia, or
             albumin-corrected serum calcium above the reference range from the sample taken at the
             Washout/Screening Visit.

          -  Known or suspected severe renal insufficiency, severe hepatic disorders or severe
             heart disease.

          -  Known or suspected hypersensitivity to any components of the investigational products.

          -  Clinical signs or symptoms of Cushing's disease or Addison's disease

          -  Current participation in any other interventional clinical study.

          -  Subjects 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 the 4 weeks prior to randomisation, or longer if the class of substance
             requires a longer washout as defined in exclusion criterion number 1 for biological
             treatments.

          -  Females who are pregnant, wishing to become pregnant during the study, or are
             breast-feeding.

          -  Patients suspected of being unable to comply with the study protocol, e.g. due to
             alcoholism, drug dependence or psychotic state.

          -  Previous randomisation in this study.

          -  Hospitalised patients.