A Psoriasis Plaque Test With LEO 29102 Cream and Its Combination Products
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Intervention: LEO 29102 cream; LEO 29102 Cream Vehicle; Betamethasone Dipropionate Cream; LEO 29102 Plus Calcipotriol Cream; LEO 29102 Plus Betamethasone Dipropionate; Daivobet® Ointment
Intervention MeSH terms: Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Calcipotriene; Betamethasone sodium phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this trial is to evaluate the anti-psoriatic effect of LEO 29102 cream and its
      combination with calcipotriol and betamethasone using a psoriasis plaque test method.
    

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