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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LEO Pharma
ClinicalTrials.gov Identifier:
NCT00704262
First received: June 23, 2008
Last updated: October 30, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention Phase
Psoriasis Vulgaris
Drug: Calcipotriol plus hydrocortisone (LEO 80190)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by LEO Pharma:

Primary Outcome Measures:
  • Effect on the hypothalamic-pituitary-adrenal axis and effect on the calcium metabolism [ Time Frame: Week 4 and 8 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall disease severity of the face and intertriginous areas according to the investigator´s global assessment of disease severity. [ Time Frame: Week 4 and 8 ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: May 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Calcipotriol plus hydrocortisone (LEO 80190) Drug: Calcipotriol plus hydrocortisone (LEO 80190)
Once daily application

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00704262

Locations
United States, Arkansas
Burke Pharmaceuticals
Hot Springs, Arkansas, United States, 71913
Dermatology Research of Arkansas
Little Rock, Arkansas, United States, 72205
United States, Florida
Ameriderm Research
Ormond Beach, Florida, United States, 32174
United States, Michigan
Somerset Skin Center
Troy, Michigan, United States, 48084
United States, New Jersey
Psoriasis Treatment Center of Central NJ
East Windsor, New Jersey, United States, 08520
United States, Virginia
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States, 23507
Canada, Ontario
The Guenther Dermatology Research Centre
London, Ontario, Canada, N6A3H7
Germany
Institute of Clinical Pharmacology Parexel International Gmbh
Berlin, Germany, 12351
United Kingdom
LCG Bioscience
Bourn, Cambridge, United Kingdom, CB3 7TR
The Dermatology Centre, Hope Hospital
Manchester, United Kingdom, M6 8HD
ICON Development Solutions
Manchester, United Kingdom, M15 6SH
Sponsors and Collaborators
LEO Pharma
Investigators
Principal Investigator: Rainard Fuhr, MD, PhD Institute of Pharmacology Parexel International GmbH, Spandauer Damm 130, Haus 31, 14050 Berlin, Germany
  More Information

No publications provided

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT00704262     History of Changes
Other Study ID Numbers: LEO 80190-O23
Study First Received: June 23, 2008
Last Updated: October 30, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
Canada: Health Canada

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Cortisol succinate
Hydrocortisone
Hydrocortisone-17-butyrate
Calcipotriene
Calcitriol
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Cardiovascular Agents
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 28, 2014