LEO 90100 in the Treatment of Psoriasis Vulgaris
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Intervention: LEO 90100; Calcipotriol; Betamethasone
Intervention MeSH terms: Calcitriol; Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Calcipotriene; Betamethasone sodium phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 303.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to investigate whether LEO 90100, calcipotriol and betamethasone
      are effective in the treatment of psoriasis vulgaris.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed and dated informed consent obtained prior to any trial related activities
             (including washout period).

          -  Age 18 years or above

          -  Either sex

          -  Any race or ethnicity

          -  All skin types

          -  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).

          -  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 8 weeks prior to randomisation

               -  ustekinumab - within 16 weeks prior to randomisation

               -  other products - 4 weeks/5 half-lives (whichever is longer)

          -  Systemic treatment with all other therapies with a possible effect on psoriasis
             vulgaris (e.g., corticosteroids, retinoids, methotrexate, ciclosporin and other
             immunosuppressants) within 4 weeks prior to randomisation.

          -  Subjects who have received treatment with any nonmarketed drug substance (i.e. a drug
             which has not yet been made available for clinical use following registration) within
             4 weeks/5 half-lives (whichever is longer) prior to randomisation.

          -  PUVA therapy within 4 weeks prior to randomisation.

          -  UVB therapy within 2 weeks prior to randomisation.

          -  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.

          -  Planned initiation of, or changes to, concomitant medication that could affect
             psoriasis vulgaris (e.g. beta blockers, antimalarial drugs, 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,
             acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, icthyosis,
             ulcers and wounds.

          -  Other inflammatory skin disorders (e.g. seborrhoeic dermatitis or contact dermatitis)
             on the treatment area that may confound the evaluation of psoriasis vulgaris.

          -  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.

          -  Previously randomised in this study.

          -  Females who are pregnant, wishing to become pregnant during the study, or are
             breast-feeding.