A Psoriasis Plaque Test Trial With LEO 90100 Compared to Betesil® in Patients With Psoriasis Vulgaris
Condition: Skin and Connective Tissue Diseases
MeSH terms: Psoriasis; Connective Tissue Diseases
Intervention: LEO 90100 Aerosol foam; Betesil® 2.25 mg
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriasis

Summary:

      The purpose of this study is to evaluate the anti-psoriatic effect of LEO 90100 aerosol foam
      compared with Betesil® medicated plaster
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed and dated informed consent has been obtained

          -  Subjects with a diagnosis of psoriasis vulgaris with preferably three lesions
             (plaques) located on arms, legs and/or trunk or at least two lesions (plaques) located
             on arms, legs and/or trunk. For subjects with three lesions, each lesion must have a
             size suitable to accommodate 2 test sites (test site area 5 cm2, distance between two
             test sites at least 2 cm). For subjects with two lesions, one lesion must have a size
             suitable to accommodate 4 test sites, and the other lesion must accommodate 2 test
             sites.

          -  Age 18 years or above

          -  Outpatients

          -  Female subjects must be of either

               -  non-childbearing potential, i.e. post-menopausal or have a confirmed clinical
                  history of sterility (e.g. the subject is without a uterus or has tubal ligation)
                  or,

               -  child-bearing potential provided there is a confirmed negative pregnancy test
                  prior to trial treatment to rule out pregnancy.

        Exclusion Criteria:

          -  Female subjects who are breast feeding

          -  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 and during the trial

               -  Adalimumab, infliximab - within 8 weeks prior to randomisation and during the
                  trial

               -  Ustekinumab - within 16 weeks prior to randomisation and during the trial

               -  Other products - within 4 weeks/5 half-lives prior to randomisation and during
                  the trial (whichever is longer)

          -  Systemic treatment with all other therapies than biologicals, with a potential effect
             on psoriasis vulgaris (e.g., corticosteroids, retinoids, immunosuppressants) within
             the 4-week period prior to randomisation and during the trial

          -  Subjects using phototherapy within the following time periods prior to randomisation
             and during the trial:

               -  PUVA: 4 weeks

               -  UVB: 2 weeks

          -  Subjects using one of the following topical drugs for the treatment of psoriasis
             within the 4 week period prior to randomisation and during the trial:

               -  Potent or very potent (WHO group III-IV) corticosteroids

          -  Subjects using one of the following topical drugs for the treatment of psoriasis
             within 2 weeks prior to randomisation and during the trial:

               -  WHO group I-II corticosteroids (except if used for treatment of scalp and/or
                  facial psoriasis)

               -  Topical retinoids, Vitamin D analogues, Topical immunomodulators (e.g.
                  calcineurin inhibitors), Tar products, Salicylic acid

          -  Subjects using emollients on the selected plaques within 1 week before randomisation
             and during the trial

          -  Initiation of, or expected changes to concomitant medication that may affect psoriasis
             vulgaris (e.g., beta blockers, antimalarial drugs, lithium and ACE inhibitors) within
             2 weeks prior to the randomisation and during the trial

          -  Subjects with current diagnosis of guttate, erythrodermic, exfoliative or pustular
             psoriasis