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

LEO Pharma

Status and phase: Completed; Phase 3

Conditions: Psoriasis Vulgaris

Treatments: Drug: Calcipotriol plus hydrocortisone ointment vehicle; Drug: Tacalcitol Ointment; Drug: Calcipotriol plus hydrocortisone ointment

Study type: Interventional

Funder types: Industry

Identifiers

NCT00640822

LEO 80190-O22

Details and patient eligibility

About

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

Enrollment: 782 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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782 participants in 3 patient groups, including a placebo group

Calcipotriol plus Hydrocortisone ointment

Experimental group

Description:

Calcipotriol plus Hydrocortisone ointment once daily for up to 8 weeks

Treatment:

Drug: Calcipotriol plus hydrocortisone ointment

Tacalcitol

Active Comparator group

Description:

Tacalcitol once daily for up to 8 weeks

Treatment:

Drug: Tacalcitol Ointment

Calcipotriol plus Hydrocortisone ointment vehicle

Placebo Comparator group

Description:

Calcipotriol plus Hydrocortisone ointment vehicle once daily for up to 8 weeks

Treatment:

Drug: Calcipotriol plus hydrocortisone ointment vehicle