Official Title: “A Phase 3 Study Comparing an Ointment Containing Calcipotriol 25 Mcg/g Plus Hydrocortisone 10 mg g With Tacalcitol 4 Mcg/g Ointment and the Ointment Vehicle Alone, All Applied Once Daily in the Treatment of Psoriasis Vulgaris on the Face and on the Intertriginous Areas”

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 compare the efficacy and safety of once daily treatment for up to 8 weeks of an ointment containing calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g with tacalcitol 4 mcg/g ointment and the ointment vehicle alone in patients with psoriasis vulgaris on the face and on the intertriginous ares

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: March 2009

Intervention(s) in this Clinical Trial

• Drug: Calcipotriol and hydrocortisone (LEO 80190)
  • Once daily application

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
• Active Comparator: 2
• Placebo Comparator: 3

Primary Measures

• Overall disease severity of the face according to the investigator's assessment
  • Time Frame: Week 8
    Safety Issue?: No

Secondary Measures

• Overall disease severity of the face according to the investigator's assessment
  • Time Frame: Week 4
    Safety Issue?: No
• Total Sign Score of the face
  • Time Frame: Week 8
    Safety Issue?: No
• Severity scores for redness, thickness and scaliness of the face
  • Time Frame: Week 8
    Safety Issue?: No
• Overall disease severity of the intertriginous areas according to the investigator's assessment
  • Time Frame: Week 8
    Safety Issue?: No
• Total Sign Score of the intertriginous areas
  • Time Frame: Week 8
    Safety Issue?: No
• Patients with relapse during the study and time to relapse
  • Time Frame: Week 8-16
    Safety Issue?: No
• Patients with rebound during the study
  • Time Frame: Week 8-16
    Safety Issue?: Yes

Inclusion Criteria:

• Clinical diagnosis of psoriasis vulgaris involving the face
• Clinical signs of psoriasis vulgaris on the trunk and/or the limbs, or earlier diagnosed with psoriasis vulgaris on the trunk and/or the limbs
• An extent of psoriatic involvement of the face of at least 10 cm2 (the sum of all facial lesions)
• Treatment areas (the face and the intertriginous areas) amenable to topical treatment with a maximum of 10 g of ointment per day
• Disease severity graded as mild, moderate, severe or very severe according to the investigator's global assessment of disease severity of the face

Exclusion Criteria:

• Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, vitamin D analogues, retinoids, immunosuppressants) within the 4-week period prior to randomisation
• Systemic use of biological treatments, whether marketed or not, directed against or with a potential effect on psoriasis vulgaris (e.g., alefacept, efalizumab, etanercept, infliximab, adalimumab) within 3 months prior to randomisation
• PUVA therapy or Grenz ray therapy within the 4-week period prior to randomisation
• UVB therapy within the 2-week period prior to randomisation
• Topical treatment of the face and the intertriginous areas within the 2-week period prior to randomisation (use of emollients is allowed on treatment areas during this 2-week period, but not during the study)
• Topical treatment with very potent WHO group IV corticosteroids within the 2-week period prior to randomisation
• Initiation of or expected changes in concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, anti-malaria drugs, lithium and ACE inhibitors) during the study
• Systemic treatment with vitamin D preparations above 500 IU per day
• 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., seborrhiec 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, UVA or UVB that may affect the psoriasis vulgaris during the study
• Known or suspected severe renal insufficiency or severe hepatic disorders
• Known or suspected disorders of calcium metabolism associated with hypercalcemia

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: LEO Pharma

Overall Clinical Trial Officials and Contacts

Colin Fleming, MD Principal Investigator Ninewells Hospital & Medical School  

Overall Contact: Kirsten L Nørrelund, MSc Pharm +4544945888 kirsten.noerrelund@leo-pharma.com

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00640822

Study ID Number: LEO 80190-O22

ClinicalTrials.gov Identifier: NCT00640822

Health Authority: Canada: Health Canada