LEO 80185 in the Treatment of Psoriasis Vulgaris on the Non-scalp Regions of the Body (Trunk and/or Limbs)
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Intervention: Calcipotriol plus betamethasone; Betamethasone-17,21-dipropionate; Calcipotriene; Topical suspension vehicle
Intervention description: Topical suspension once daily for up to 8 weeks.; Topical suspension once daily for up to 8 weeks.; Topical suspension once daily for up to 8 weeks.; Topical suspension once daily for up to 8 weeks.
Intervention MeSH terms: 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: Double (Participant, Investigator)
Enrollment: 1152.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the efficacy and safety of Calcipotriol 50 Mcg/g Plus
      Betamethasone 0.5 mg/g (as Dipropionate) Topical Suspension with the active components when
      used individually as monotherapy in the topical suspension vehicle (betamethasone
      dipropionate in the topical suspension vehicle, calcipotriol in the topical suspension
      vehicle) and with the topical suspension vehicle alone in the treatment of psoriasis vulgaris
      on the non-scalp regions of the body (trunk and/or limbs) in a large phase 3 study. This
      comparison will ensure a more informed assessment of the benefit/risk ratio of Calcipotriol
      50 Mcg/g Plus Betamethasone 0.5 mg/g (as Dipropionate) Topical Suspension while also
      establishing the optimal treatment duration in psoriasis vulgaris on the non-scalp regions of
      the body (trunk and/or limbs).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed and dated informed consent obtained prior to any trial related activities
             (including any washout period).

          -  Aged 18 years or above

          -  Either sex

          -  Any race or ethnicity

          -  Attending a hospital outpatient clinic or the private practice of a board certified
             dermatologist.

          -  Clinical diagnosis of stable plaque psoriasis vulgaris of at least 6 months duration
             involving the non-scalp regions of the body (trunk and/or limbs) amenable to treatment
             with a maximum of 100 g of topical medication per week.

          -  An investigator's global assessment of disease severity (IGA) of mild or moderate on
             the body (trunk and/or limbs) at Day 0 (Visit 1).

          -  A minimum modified Psoriasis Area and Severity Index (PASI) 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)

          -  Females of childbearing potential must have a negative pregnancy test at Day 0 (Visit
             1).

          -  Females of childbearing potential must agree to use a highly effective method of birth
             control during the study. A highly effective method of birth control is defined as one
             which results in a low failure rate (less than 1% per year) such as implants,
             injectables, combined oral contraceptives, some intrauterine devices, sexual
             abstinence or vasectomised partner. The patients must have used the contraceptive
             method continually for at least 1 month prior to the pregnancy test, and must continue
             using the contraceptive method 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 alternative medical cause), or
             surgically sterile (tubal ligation/section, hysterectomy or bilateral ovariectomy).

          -  Able to communicate with the investigator and understand and comply with the
             requirements of the study.

        Exclusion Criteria:

          -  Systemic treatment with biological therapies, whether marketed or not, with a possible
             effect on psoriasis vulgaris within the following time periods prior to randomisation:

               -  etanercept - within 4 weeks prior to randomisation

               -  adalimumab, alefacept, infliximab - within 2 months prior to randomisation

               -  ustekinumab - within 4 months prior to randomisation

               -  experimental products - within 4 weeks/5 half-lives (whichever is longer) prior
                  to randomisation

          -  Systemic treatment with all other therapies with a possible effect on psoriasis
             vulgaris (e.g., corticosteroids, retinoids, methotrexate, cyclosporine and other
             immunosuppressants) within 4 weeks prior to randomisation.

          -  PUVA or Grenz ray therapy within 4 weeks prior to randomisation.

          -  UVB therapy within 2 weeks prior to randomisation.

          -  Any topical treatment of the trunk and/or limbs (except for emollients) within 2 weeks
             prior to randomisation.

          -  Topical treatment for other relevant skin disorders on the face and flexures (e.g.,
             facial and flexural psoriasis, eczema) with class 1- 5 corticosteroids or vitamin D
             analogues within 2 weeks prior to randomisation.

          -  Topical treatment for other relevant skin disorders on the scalp (e.g. scalp
             psoriasis) with class 1-5 corticosteroids, vitamin D analogues or prescription
             shampoos within 2 weeks prior to randomisation.

          -  Planned initiation of, or changes to, concomitant medication that could affect
             psoriasis vulgaris (e.g. beta blockers, anti-malarials, lithium, ACE inhibitors)
             during the study.

          -  Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis.

          -  Subjects with any of the following conditions present on the treatment area: viral
             (e.g. herpes or varicella) lesions of the skin, fungal and bacterial skin infections,
             parasitic infections, skin manifestations in relation to syphilis or tuberculosis,
             rosacea, perioral dermatitis, acne vulgaris, atrophic skin, striae atrophicae,
             fragility of skin veins, icthyosis, acne rosacea, ulcers and wounds.

          -  Known or suspected disorders of calcium metabolism associated with hypercalcaemia.

          -  Known or suspected severe renal insufficiency or severe hepatic disorders.

          -  Known or suspected hypersensitivity to component(s) of the investigational products.

          -  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-week period prior to randomisation or longer, if the class of substance
             required a longer washout as defined above (e.g. biological treatments).

          -  Planned excessive exposure to the sun during the study that may affect the psoriasis
             vulgaris.

          -  Previously randomised in this study.

          -  Females who are pregnant, have a positive pregnancy test at Day 0 (Visit 1), or are
             breast-feeding. Females of child-bearing potential wishing to become pregnant during
             the study, or not using an adequate method of contraception during the study.