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

NCT ID: NCT00704262

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2009-12-31

Brief 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

Conditions

Psoriasis Vulgaris

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Calcipotriol plus hydrocortisone (LEO 80190)

Group Type: EXPERIMENTAL

Calcipotriol plus hydrocortisone (LEO 80190)

Intervention Type: DRUG

Once daily application

Interventions

Calcipotriol plus hydrocortisone (LEO 80190)

Once daily application

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LEO Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rainard Fuhr, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute of Pharmacology Parexel International GmbH, Spandauer Damm 130, Haus 31, 14050 Berlin, Germany

Locations

Burke Pharmaceuticals

Hot Springs, Arkansas, United States

Dermatology Research of Arkansas

Little Rock, Arkansas, United States

Ameriderm Research

Ormond Beach, Florida, United States

Somerset Skin Center

Troy, Michigan, United States

Psoriasis Treatment Center of Central NJ

East Windsor, New Jersey, United States

Virginia Clinical Research, Inc.

Norfolk, Virginia, United States

The Guenther Dermatology Research Centre

London, Ontario, Canada

Institute of Clinical Pharmacology Parexel International Gmbh

Berlin, , Germany

LCG Bioscience

Bourn, Cambridge, United Kingdom

ICON Development Solutions

Manchester, , United Kingdom

The Dermatology Centre, Hope Hospital

Manchester, , United Kingdom

Countries

United States; Canada; Germany; United Kingdom

Other Identifiers

LEO 80190-O23

Identifier Type: -

Identifier Source: org_study_id