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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.
Verified by LEO Pharma, April 2008

Sponsored by: LEO Pharma
Information provided by: LEO Pharma
ClinicalTrials.gov Identifier: NCT00704262
  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 II

MedlinePlus related topics:   Psoriasis   

ChemIDplus related topics:   Hydrocortisone    Cortisol 21-phosphate    Cortisol succinate    Hydrocortamate    Hydrocortisone 21-sodium succinate    Hydrocortisone acetate    Hydrocortisone cypionate    Hydrocortisone hemisuccinate    Proctofoam-HC    Calcium gluconate    Calcipotriene    Epinephrine    Epinephrine bitartrate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

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 ]

Estimated Enrollment:   30
Study Start Date:   May 2008
Estimated Study Completion Date:   September 2009
Estimated Primary Completion Date:   April 2009 (Final data collection date for primary outcome measure)

Intervention Details:
    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 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
  Contacts and Locations

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

Contacts
Contact: Vibeke Hoffmann, MSc Pharm     45-4494-5888     vibeke.hoffmann@leo-pharma.com    
Contact: Maj Britt Larsen, Phd     45-4494-5888     maj.larsen@leo-pharma.com    

Locations
Germany
Parexel International Gmbh, Klinikum Neukölln, Klinik 2, Pavillon 12, Rudower Strasse 48     Recruiting
      Berlin, Germany, 12351
      Contact: Dago Mazur, MD, PhD     49-3030-685-4055     dago.mazur@parexel.com    
United Kingdom
The Dermatology Centre, Hope Hospital     Not yet recruiting
      Manchester, United Kingdom, M6 8HD
      Contact: Christopher Griffiths, Professor     44-0161-206-4392        

Sponsors and Collaborators
LEO Pharma

Investigators
Principal Investigator:     Dago Mazur, MD, PhD     Parexel International GmbH, Klinikum Neukölln, Klinik 2, Pavillon 12, Rudower Strasse 48, 12531 Berlin, Germany    
  More Information

Responsible Party:   LEO Pharma A/S ( Vibeke Hoffmann, Principal Clinical Project Manager )
Study ID Numbers:   LEO 80190-O23
First Received:   June 23, 2008
Last Updated:   June 23, 2008
ClinicalTrials.gov Identifier:   NCT00704262
Health Authority:   Germany: Federal Institute for Drugs and Medical Devices;   United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:
Calcipotriene
Hydrocortisone
Cortisol succinate
Skin Diseases
Facies
Psoriasis
Hydrocortisone acetate
Epinephrine
Skin Diseases, Papulosquamous

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Therapeutic Uses
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008




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