CompletedPhase 3

Efficacy and Safety of Calcipotriol Plus Hydrocortisone Ointment in Psoriasis Vulgaris on the Face and Skin Folds

Croatia, Germany, Poland1,245 participantsStarted 2008-05

Plain-language 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 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 calcipotriol 25 mcg/g in the ointment vehicle, hydrocortisone 10 mg/g in the ointment vehicle and the ointment vehicle alone in patients with psoriasis vulgaris on the face and on the intertriginous areas (= double-blind phase). Furthermore, the safety and efficacy will be evaluated for up to 60 weeks treatment as required of calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g ointment in psoriasis vulgaris on the face and intertriginous areas (= open-label phase).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 100 g of ointment per week * 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 double-blind phase of the study) * Topical tre…

What they're measuring

Participants With "Controlled Disease" According to the Investigator's Global Assessment(IGA) of Disease Severity of the Face at Week 8 (Visit 6) in the Double-blind Phase

Timeframe: At Week 8 (end of treatment for double-blind phase)

Trial details

NCT IDNCT00691002

SponsorLEO Pharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-01

Results submitted2018-01-29