A Psoriasis Plaque Test Study With LEO 90100 Cutaneous Spray, Ointment, in Psoriasis Vulgaris
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Intervention: LEO90100 cutaneous spray, ointment; LEO 90100 cutaneous spray, ointment, vehicle with betamethasone dipropionate; LEO 90100 cutaneous spray, ointment, vehicle; Daivobet® ointment
Intervention description: once daily application, 4 weeks; once daily application, 4 weeks; once daily application, 4 weeks; once daily application, 4 weeks
Intervention MeSH terms: Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Betamethasone sodium phosphate
Phase: Phase 2
Study type: Interventional
Allocation: Randomized
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 90100 cutaneous
      spray ointment, using the psoriasis plaque test modified from the method developed by KJ
      Dumas and JR Scholtz.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects having signed and dated an informed consent

          2. Age 18 years or above

          3. Either sex

          4. All skin types

          5. Subjects with a diagnosis of psoriasis vulgaris with lesions located on arms, legs
             and/or trunk.

        Exclusion Criteria:

          1. Females who are pregnant, of child-bearing potential and who wish to become pregnant
             during the study, or who are breast feeding

          2. 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 is longer)for experimental biological products prior to randomisation and
             during the study

          3. Systemic treatments 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 study

          4. Use of phototherapy within the following time periods prior to randomisation and
             during the study:

               -  PUVA or Grenz ray therapy (4 weeks)

               -  UVB (2 weeks)

          5. Subjects using one of the following topical drugs within 4 weeks prior to
             randomisation and during the study:

               -  Potent or very potent (WHO group III-IV) corticosteroids

          6. Subjects using one of the following topical drugs for the treatment of psoriasis
             within 2 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. calcineurin inhibitors)

               -  Anthracen derivatives

               -  Tar

               -  Salicylic acid

          7. Subjects using emollients on the target plaques within one week before randomisation
             and during the study

          8. Initiation of, or expected changes in concomitant medication that may affect psoriasis
             vulgaris (e.g., beta blockers, anti-malaria drugs, lithium and ACE inhibitors) within
             2 weeks prior to randomisation and during the study

          9. Subjects with current diagnosis of guttate, erythrodermic, exfoliative or pustular
             psoriasis

         10. Subjects with known/suspected disorders of calcium metabolism associated with
             hypercalcemia within the last 10 years, based on medical history

         11. Subjects with any of the following conditions present on the test area: viral (e.g.
             herpes or varicella) lesions of the skin, fungal and bacterial skin infections,
             parasitic infections and atrophic skin

         12. Subjects with skin manifestations in relation to syphilis or tuberculosis, rosacea,
             perioral dermatitis, acne vulgaris, atrophic skin, striae atrophicae, fragility of
             skin veins, ichthyosis, acne rosacea, ulcers and wounds within the plaque test areas

         13. History of any severe disease or serious current condition (based on subject interview
             and/or results of screening physical examination) which, in the opinion of the
             Investigator, would put the subject at risk by participating in the study or would
             interfere significantly with the evaluation of study results or the study course (e.g.
             cancer, severe cardiopathy, severe renal insufficiency, severe hepatic insufficiency)

         14. 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)

         15. Subjects with current participation in any other interventional clinical trial, based
             on interview of the subject

         16. Subjects with known or suspected hypersensitivity to component(s) of the
             investigational products

         17. Subjects with any concomitant medical or dermatological disorder(s) which might
             preclude accurate evaluation of the psoriasis

         18. Subjects foreseeing an intensive solar exposure during the study (UV radiation, etc.)
             or having been exposed within two weeks preceding the screening visit

         19. Subjects impossible to contact in case of emergency

         20. Subjects who are known or, in the opinion of the investigator, are unlikely to comply
             with the Clinical Study Protocol (e.g. alcoholism, drug dependency or psychotic state)

         21. Subjects who are in an exclusion period in the National Biomedical Research Register
             of the French Ministry of Health at randomisation

         22. Subjects under guardianship, hospitalized in a public or private institution, for a
             reason other than the research or subject deprived of freedom

         23. Subjects previously randomised in this trial