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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 is currently recruiting participants.
Study NCT00704262.   Last updated on November 18, 2008.   Information provided by LEO Pharma

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Descriptive Information Fields
Brief Title  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 HPA Axis and Calcium Metabolism in Patients With Psoriasis Vulgaris on the Face and on the Intertriginous Areas
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

Detailed Description
Study Phase Phase II
Study Type  Interventional
Study Design  Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary Outcome Measure  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 Measure  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 ]
Condition  Psoriasis Vulgaris
Intervention  Drug: Calcipotriol plus hydrocortisone (LEO 80190)
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  30
Start Date  May 2008
Completion Date September 2009
Eligibility 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 10 cm2 and on the intertriginous areas of at least 20 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) injection and serum corticol concentration above 18 mcg/dl 30 min after ATCT (tetracosactid) 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) 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, immunosuppressants) within 2 weeks prior to Visit 1
  • Systemic treatment with corticosteroids within 12 weeks prior to Visit 1
  • Systemic use uf 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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: Maj Britt Larsen, Phd     45-4494-5888     maj.larsen@leo-pharma.com    
Contact: Vibeke Hoffmann, MSc Pharm     45-4494-5888     vibeke.hoffmann@leo-pharma.com    
Location Countries  Germany,   United Kingdom
Administrative Information Fields
NCT ID  NCT00704262
Organization ID LEO 80190-O23
Secondary IDs ††
Study Sponsor  LEO Pharma
Collaborators ††
Investigators 
Principal Investigator:     Dago Mazur, MD, PhD     Parexel International GmbH, Klinikum Neukölln, Klinik 2, Pavillon 12, Rudower Strasse 48, 12531 Berlin, Germany    
Information Provided By LEO Pharma
Verification Date November 2008
First Received Date  June 23, 2008
Last Updated Date November 18, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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