A Plaque Test Comparing the Anti-psoriatic Effect of Marketed Products for Topical Use for Psoriasis Vulgaris
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Intervention: Daivobet® ointment; Betnovat® ointment; Diprosalic ointment; Dermovat ointment; Elocon ointment; Daivobet® ointment vehicle
Intervention description: Once daily application 6 days a week for 3 weeks; Once daily application 6 days a week for 3 weeks; Once daily application 6 days a week for 3 weeks; Once daily application 6 days a week for 3 weeks; Once daily application 6 days a week for 3 weeks; Once daily application 6 days a week for 3 weeks
Intervention MeSH terms: Calcitriol; Betamethasone
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 compare the anti-psoriatic effect of marketed products with
      Daivobet® ointment in a plaque test
    

Eligibility criteria:

        Inclusion Criteria: (in summary)

          -  Subjects having understood and signed an informed consent form

          -  All skin types

          -  Subjects with a diagnosis of psoriasis vulgaris with lesions located on arms, legs or
             trunk. The lesions must have a total size suitable for application. The subjects
             should be asked if their lesions have been stable

          -  Subjects willing and able to follow all the study procedures and complete the whole
             study

          -  Subjects affiliated to social security system

        Exclusion Criteria: (in summary)

          -  Females who are pregnant, of child-bearing potential and who wish to become pregnant
             during the study, or who are breast feeding

          -  Subjects using biological therapies (marketed or not marketed) with a possible effect
             on psoriasis (e.g. alefacept, efalizumab, etanercept, infliximab, adalimumab) within
             12 weeks prior to study drug administration

          -  Systemic treatments with all other therapies than biologicals, with a potential effect
             on psoriasis vulgaris (e.g., corticosteroids, vitamin D-analogues, retinoids,
             immunosuppressants) within the 4-week period prior to randomisation

          -  Subjects using one of the following topical drugs for the treatment of psoriasis
             within four (4) weeks prior to study drug administration: - Potent or very potent (WHO
             group III-IV) corticosteroids - PUVA or Grenz ray therapy

          -  Subjects using one of the following topical drugs for the treatment of psoriasis
             within two (2) weeks prior to study drug administration: - WHO group I-II
             corticosteroids - Topical retinoids - Vitamin D-analogues - Topical immunomodulators
             (e.g. macrolides) - Anthracen derivatives - Tar - Salicylic acid - UVB therapy

          -  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