Clinical trial NCT00704262: 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
Official title: Effect of Calcipotriol Plus Hydrocortisone Ointment on the Hypothalamic-pituitary-adrenal (HPA) Axis and Calcium Metabolism in Patients With Psoriasis Vulgaris on the Face and on the Intertriginous Areas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis Vulgaris
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2008-06-24
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: The Adrenal Response to the ACTH Challenge Test Defined as the Serum Cortisol Concentration Obtained After 30 and 60 Minutes
timeFrame: At Week 4 (Day 28) and Week 8 (Day 56)
measure: Change in Albumin Corrected Serum Calcium
timeFrame: From baseline to Week 4, Week 8, and end of treatment (last value recorded i.e. Week 4, 6, or 8)
Secondary outcomes:
measure: The Adrenal Response to the ACTH Challenge Test Defined as the Serum Cortisol Concentration Obtained After 30 Minutes
timeFrame: At Week 4 and Week 8
measure: The Adrenal Response to the ACTH Challenge Test Defined as the Serum Cortisol Concentration Obtained After 60 Minutes
timeFrame: At Week 4 and Week 8
measure: Serum Cortisol Concentration After 30 Minutes
timeFrame: At Week 4 and Week 8
measure: Serum Cortisol Concentration After 60 Minutes
timeFrame: At Week 4 and Week 8
measure: Change in Albumin Corrected Serum Calcium
timeFrame: From baseline to Week 2 and Week 6
measure: Albumin Corrected Serum Calcium
timeFrame: At Week 2, Week 4, Week 6 and Week 8 and end of treatment (last value recorded i.e. Week 4, 6, or 8)
measure: Albumin Corrected Serum Calcium Values Above the Upper Limit of the Reference Range
timeFrame: At Week 2, Week 4, Week 6 and Week 8 and end of treatment (last value recorded i.e. Week 4, 6, or 8)
measure: Participants With "Controlled Disease" ("Clear" or "Almost Clear") According to the Investigator's Global Assessment of Disease Severity (IGA) of the Face
timeFrame: At Week 4, Week 8 and end of treatment (last value recorded i.e. Week 4, 6, or 8)
measure: Participants With "Controlled Disease" ("Clear" or "Almost Clear") According to the IGA of the Intertriginous Areas
timeFrame: At Week 4, Week 8 and end of treatment (last value recorded i.e. Week 4, 6, or 8)
measure: Overall Disease Severity of the Face According to the IGA
timeFrame: At baseline, Week 2, Week 4, Week 6, Week 8, and end of treatment (last value recorded i.e. Week 4, 6, or 8)
measure: Overall Disease Severity of Intertriginous Areas According to the IGA
timeFrame: At baseline, Week 2, Week 4, Week 6, Week 8, and end of treatment (last value recorded i.e. Week 4, 6, or 8)
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: Burke Pharmaceuticals
state: Arkansas
city: Little Rock
country: United States
facility: Dermatology Research of Arkansas
state: Arkansas
city: Ormond Beach
country: United States
facility: Ameriderm Research
state: Florida
city: Troy
country: United States
facility: Somerset Skin Center
state: Michigan
city: East Windsor
country: United States
facility: Psoriasis Treatment Center of Central NJ
state: New Jersey
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
city: London
country: Canada
facility: The Guenther Dermatology Research Centre
state: Ontario
city: Berlin
country: Germany
facility: Institute of Clinical Pharmacology Parexel International Gmbh
city: Bourn
country: United Kingdom
facility: LCG Bioscience
state: Cambridge
city: Manchester
country: United Kingdom
facility: ICON Development Solutions
city: Manchester
country: United Kingdom
facility: The Dermatology Centre, Hope Hospital
Study officials:
affiliation: Institute of Pharmacology Parexel International GmbH, Spandauer Damm 130, Haus 31, 14050 Berlin, Germany
name: Rainard Fuhr, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: