AgingResearch.NewsJoin free

Phase 3Completed

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

Calcipotriol Plus Hydrocortisone in Psoriasis Vulgaris on the Face and on the Intertriginous Areas

Sponsor
LEO Pharma (Industry)
Enrollment
1,245 enrolled
Conditions
Psoriasis Vulgaris
Interventions
Calcipotriol plus hydrocortisone (LEO 80190); LEO 80190 Vehicle; Hydrocortisone; Calcipotriol
Ages
adults, older adults
Registry
NCT00691002

Full record on ClinicalTrials.gov

From the registry

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).

Primary outcomes

  • 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

History

  1. Last registry update

  2. Results first posted

  3. Primary completion

  4. Registered

  5. Started