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

LEO Pharma

Status and phase

Completed

Phase 2

Conditions

Psoriasis Vulgaris

Treatments

Drug: Calcipotriol plus hydrocortisone (LEO 80190)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00704262

LEO 80190-O23

Details and patient eligibility

About

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

Enrollment

33 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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