A Plaque Test Study With LEO 35299 in Psoriasis Vulgaris
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Intervention: B LEO 35299 20 mg/g cream; C LEO 35299 20 mg/g cream; E LEO 35299 10 mg/g solution; F LEO 35299 10 mg/g solution; Daivonex® ointment; Daivonex® ointment vehicle
Intervention description: once daily application, 3 weeks; once daily application, 3 weeks; once daily application, 3 weeks; once daily application, 3 weeks; once daily application, 3 weeks; once daily application, 3 weeks
Intervention MeSH terms: Calcitriol; Calcipotriene; Pharmaceutical Solutions
Phase: Phase 1
Study type: Interventional
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to evaluate the anti-psoriatic effect of LEO 35299 in different
      formulations, compared to Daivonex® ointment and Daivonex® ointment vehicle, using the
      psoriasis plaque test modified from the method developed by KJ Dumas and JR Scholtz.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Following verbal and written information about the trial, the subject must provide
             signed and dated informed consent before any study related activities are carried out.

          2. Age 18 years or above.

          3. Males, or females of non-child bearing potential.

          4. Subjects with, in the opinion of the investigator, stable psoriasis based on Total
             Plaque Score evaluated at screening visit and at visit 2 (Baseline).

        Exclusion Criteria:

          1. Male subjects who are not willing to use a local contraception (such as condom) from
             the time of study entry and for three months following the last study drug
             application.

          2. Female subjects who are pregnant, of child-bearing potential or who are breast
             feeding.

          3. Systemic treatment with biological therapies (marketed or not marketed) with a
             possible effect on psoriasis vulgaris within 4 weeks (etanercept), 2
             months(adalimumab, alefacept, infliximab), 4 months(ustekinumab) or 4 weeks/5
             half-lives (which-ever islonger) for experimental biological products prior to
             randomisation and during the study.

          4. Systemic treatments with all other therapies than biologicals, with a potential effect
             on psoriasis vulgaris (e.g., corticosteroids, retinoids, immune suppressants) within
             the 4-week period prior to randomisation and during the study.

          5. Subjects using one of the following topical drugs for the treatment of psoriasis
             within the 4 week period prior to randomisation and during the study:

             - Potent or very potent (WHO group III-IV) corticosteroids.

          6. Subjects using of phototherapy within the following time periods prior to
             randomisation and during the study:

               -  PUVA (4 weeks)

               -  UVB (2 weeks)

          7. Subjects using one of the following topical drugs for the treatment of psoriasis
             within two weeks prior to randomisation and during the study:

               -  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. macrolides)

               -  Anthracen derivatives

               -  Tar,

               -  Salicylic acid.

          8. Subjects with current diagnosis of guttate, erythrodermic, exfoliative or pustular
             psoriasis

          9. Subjects with known/suspected disorders of calcium metabolism associated with
             hypercalcemia within the last 10 years, based on medical history and/or subject
             interview

         10. 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 the
             substance requires a longer washout as defined above (e.g., biological treatments)

         11. Subjects with current participation in any other interventional clinical, based on
             interview of the subject