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(s) targeted: Psoriasis Vulgaris

Intervention: Calcipotriol plus hydrocortisone (LEO 80190) (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: LEO Pharma

Official(s) and/or principal investigator(s):
Rainard Fuhr, MD, PhD, Principal Investigator, Affiliation: Institute of Pharmacology Parexel International GmbH, Spandauer Damm 130, Haus 31, 14050 Berlin, Germany

Overall contact:
Maj Britt Larsen, Phd, Phone: 45-4494-5888, Email: maj.larsen@leo-pharma.com

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

Official title: Effect of Calcipotriol Plus Hydrocortisone Ointment on the HPA Axis and Calcium Metabolism in Patients With Psoriasis Vulgaris on the Face and on the Intertriginous Areas

Study design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Effect on the hypothalamic-pituitary-adrenal axis and effect on the calcium metabolism

Secondary outcome: Overall disease severity of the face and intertriginous areas according to the investigator´s global assessment of disease severity.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Clinical diagnosis of psoriasis vulgaris involving the face and the intertriginou

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 ACTH (tetracosactid/cosyntropin) injection and serum corticol concentration above 18 mcg/dl 30 min after ATCT (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

- PUVA therapy or Grenz ray therapy within 4 weeks prior to Visit 1

- UVB therapy within 2 weeks prior to Visit 1

- Topical treatment with 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., seborrhoiec dermatitis, contact dermatitis

and cutaneous mycosis) that may confound the evaluation of psorisis vulgaris on the face or on the intertriginous areas

- Planned exposure to sun, 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

Maj Britt Larsen, Phd, Phone: 45-4494-5888, Email: maj.larsen@leo-pharma.com

Institute of Clinical Pharmacology Parexel International Gmbh, Berlin 12351, Germany; Recruiting
Rainard Fuhr, MD, PhD, Phone: 49-3030-685-414, Email: rainard.fuhr@parexel.com
Rainard Fuhr, MD, PhD, Principal Investigator

The Dermatology Centre, Hope Hospital, Manchester M6 8HD, United Kingdom; Recruiting
Christopher Griffiths, Professor, Phone: 44-0161-206-4392

ICON Development Solutions, Manchester M15 6SH, United Kingdom; Recruiting
Simon Constable, MD, Phone: +44 (161) 232 2715, Email: simon.constable@iconplc.com
Simon Constable, MD, Principal Investigator

Burke Pharmaceuticals, Hot Springs, Arkansas 71913, United States; Recruiting
Tim Dugan, Phone: 501-620-4449, Email: tdugan@burkepharmaceutical.com
Laura Manley, Phone: 501 620 4449, Email: lmanley@burkepharmaceutical.com
Dow Stough, MD, Principal Investigator

Dermatology Research of Arkansas, Little Rock, Arkansas 72205, United States; Recruiting
Brittany Kiele, Phone: 501-227-8422, Ext: 35, Email: brittanykiele01@yahoo.com
Betty Davis, Phone: 501-227-8422, Ext: 21, Email: Bettydavis01@sbcglobal.net
Scott Dinehart, MD, Principal Investigator

LCG Bioscience, Bourn, Cambridge CB3 7TR, United Kingdom; Recruiting
Anthony Priestley, MD, Phone: +44 (0)1954 717535
Anthony Priestley, MD, Principal Investigator

Ameriderm Research, Ormond Beach, Florida 32174, United States; Recruiting
Kathy Evans, RN, Phone: 386-898-0547, Ext: 116, Email: Kevans@Leavittmgt.com
Yvonne Douglas, Phone: 386-898-0547, Ext: 110, Email: Ydouglas@Leavittmgt.com
James A. Solomon, MD, Principal Investigator

Somerset Skin Center, Troy, Michigan 48084, United States; Recruiting
Dianna Fortunato, Phone: 248-244-8448, Email: Dianna@somersetskincentre.com
Heather Minard, Phone: 248-244-8448, Email: Heather@somersetskincentre.com
George Murakawa, MD, Principal Investigator

Psoriasis Treatment Center of Central NJ, East Windsor, New Jersey 08520, United States; Recruiting
Elise Nelson, Phone: 609-443-4501, Ext: 36, Email: elisepsoriasis@aol.com
Sandy Sanderstokes, Phone: 609-443-4501, Ext: 29, Email: sandypsoriasis@aol.com
Jerry Bagel, MD, Principal Investigator

The Guenther Dermatology Research Centre, London, Ontario N6A3H7, Canada; Recruiting
Lyn Guenther, MD, Phone: +1 519 435 1738, Email: dgue@gdrc.ca
Lyn Guenther, MD, Principal Investigator

Virginia Clinical Research, Inc., Norfolk, Virginia 23507, United States; Recruiting
JoEllen Wyer, Phone: 757-625-0151, Ext: 52, Email: jwyer@vcrinc.org
Rebecca Heroux, Phone: 757-625-0151, Ext: 13, Email: bheroux@vcrinc.org
David Pariser, MD, Principal Investigator

Starting date: May 2008
Ending date: December 2009
Last updated: August 13, 2009