Efficacy and Safety of Calcipotriol Plus Hydrocortisone Ointment Compared With Tacalcitol Ointment in Patients With Psoriasis on the Face and Skin Folds

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Psoriasis Vulgaris

Intervention / Treatment
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* Drug: Calcipotriol plus hydrocortisone ointment vehicle
* Drug: Tacalcitol Ointment
* Drug: Calcipotriol plus hydrocortisone ointment


Participation Criteria
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Eligibility Criteria
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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., seborrhoeic 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Calcipotriol plus Hydrocortisone ointment<br>Calcipotriol plus Hydrocortisone ointment once daily for up to 8 weeks | Drug: Calcipotriol plus hydrocortisone ointment<br>* Once daily application for up to 8 weeks<br>|
| Active Comparator: Tacalcitol<br>Tacalcitol once daily for up to 8 weeks | Drug: Tacalcitol Ointment<br>* Once daily application for up to 8 weeks<br>|
| Placebo Comparator: Calcipotriol plus Hydrocortisone ointment vehicle<br>Calcipotriol plus Hydrocortisone ointment vehicle once daily for up to 8 weeks | Drug: Calcipotriol plus hydrocortisone ointment vehicle<br>* Once daily application for up to 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects With Controlled Disease According to the Investigator Assessment of the Face at Week 8 |  | Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Disease Severity of the Face According to the Investigator's Assessment |  | Week 4 | 
| Total Sign Score of the Face |  | Week 8 | 
| Severity Scores for Redness, Thickness and Scaliness of the Face |  | Week 8 | 
| Overall Disease Severity of the Intertriginous Areas According to the Investigator's Assessment |  | Week 8 | 
| Total Sign Score of the Intertriginous Areas |  | Week 8 | 
| Patients With Relapse During the Study and Time to Relapse |  | Week 8-16 | 
| Patients With Rebound During the Study |  | Week 8-16 |