Effect of Calcipotriol Plus Hydrocortisone Ointment on the Adrenal Hormone Balance and Calcium Metabolism in Patients With Psoriasis Vulgaris on the Face and Skin Folds
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Intervention: Calcipotriol plus hydrocortisone (LEO 80190)
Intervention description: Once daily application
Intervention MeSH terms: Hydrocortisone; Calcipotriene
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      There are few therapies suitable for the treatment of psoriasis on the face and skin folds.
      As these areas are sensitive, irritation and other adverse reactions are more common than
      elsewhere on the body. The purpose of the study is to monitor the effect of once daily
      treatment for up to 8 weeks of an ointment containing calcipotriol 25 mcg/g plus
      hydrocortisone 10 mg/g on the hypothalamic-pituitary-adrenal axis and on the calcium
      metabolism in patients with psoriasis vulgaris on the face and on the intertriginous areas
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of psoriasis vulgaris involving the face and the intertriginous
             areas

          -  Clinical diagnosis of psoriasis vulgaris on the trunk and/or limbs or earlier
             diagnosed with psoriasis vulgaris on the trunk and/or limbs

          -  An extent of psoriatic involvement on the face of at least 5 cm2 and the sum of all
             facial and intertriginous lesions at least 30 cm2

          -  Treatment areas (face and intertriginous) amenable to topical treatment with a maximum
             of 100g ointment per week

          -  Disease severity of the face and intertriginous areas graded as moderate, severe or
             very severe according to the investigator´s global assessment of disease severity

          -  Patients with a normal HPA axis function: serum cortisol concentration above 5 mcg/dl
             before adrenocorticotropic hormone (ACTH: tetracosactid/cosyntropin) injection and
             serum cortisol concentration above 18 mcg/dl 30 min after ACTH
             (tetracosactid/cosyntropin) injection

          -  Albumin corrected serum calcium within reference range

          -  Females of childbearing potential have to use a highly effective method of
             contraception during the study (hormonal contraceptives on oestrogen basis are not
             allowed)

        Exclusion Criteria:

          -  A history of active allergy, asthma, allergic skin rash, or sensitivity to any
             medication (including ACTH/tetracosactid/cosyntropin) or to any component of the
             formulations being tested

          -  Systemic treatment with all other therapies than biologicals, with a potential effect
             on psoriasis vulgaris (eg vitamin D analogues, retinoids)within 2 weeks prior to Visit
             1. Stable treatment with methotrexate or fumaric acid is allowed

          -  Systemic treatment with corticosteroids within 12 weeks prior to Visit 1

          -  Systemic use of biological treatments, whether marketed or not, directed against or
             with a potential effect on psoriasis vulgaris (eg. alefacept, efalizumab, etanercept,
             infliximab, adalimumab) within 12 weeks prior to Visit 1

          -  Psoralen plus ultraviolet light A (PUVA) therapy or Grenz ray therapy within 4 weeks
             prior to Visit 1

          -  Ultraviolet B (UVB) therapy within 2 weeks prior to Visit 1

          -  Topical treatment with World Health Organization (WHO) group 2, 3 or 4 corticosteroids
             within 4 weeks prior to Visit 1

          -  Topical treatment with WHO group 1 corticosteroids within 2 weeks prior to Visit 1

          -  Any topical treatment of the face and intertriginous areas (except for emollients)
             within 2 weeks prior to Visit 1

          -  Oestrogen therapy or any other medication known to affect cortisol levels or HPA-axis
             integrity within 4 weeks prior to Visit 1

          -  Enzymatic inductors, systemic or topical cytochrome P450 inhibitors, hypoglycaemic
             sulfonamides or antidepressive medication within 4 weeks prior to Visit 1

          -  Current diagnosis of erythrodermic, exfoliative, guttate or pustular psoriasis

          -  Patients with any of the following conditions present on the treatment area: viral
             (e.g., herpes or varicella) lesions of the skin, fungal and bacterial skin infections,
             parasitic infections, 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

          -  Other inflammatory skin diseases (e.g., seborrhoeic dermatitis, contact dermatitis and
             cutaneous mycosis) that may confound the evaluation of psoriasis vulgaris on the face
             or on the intertriginous areas

          -  Planned exposure to sun, Ultraviolet A (UVA) or UVB during the study that may affect
             the psoriasis vulgaris

          -  Clinical signs or symptoms of Cushing´s disease or Addison's disease

          -  Known or suspected severe renal insufficiency or severe hepatic disorders

          -  Known or suspected disorders of calcium metabolism associated with hypercalcaemia

          -  Known or suspected endocrine disorder that may affect the results of the ACTH
             challenge test