Efficacy and Safety of Calcipotriol Plus Hydrocortisone Ointment in Psoriasis Vulgaris on the Face and Skin Folds
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).
Timeline
- Start
- 2008-05
- Primary completion
- 2010-01
- Completion
- 2010-01
Outcome
Mixed primary results
registry analysis (superiority test); LEO 80190 vs Calcipotriol; p = 0.11; Odds Ratio (OR) 1.28 (95% CI 0.94 to 1.74); Cochran-Mantel-Haenszel NCT00691002 ↗
registry analysis (superiority test); LEO 80190 vs Hydrocortisone; p <0.001; Odds Ratio (OR) 1.79 (95% CI 1.31 to 2.45); Cochran-Mantel-Haenszel NCT00691002 ↗
registry analysis (superiority test); LEO 80190 vs LEO 80190 Vehicle; p <0.001; Odds Ratio (OR) 2.70 (95% CI 1.80 to 4.04); Cochran-Mantel-Haenszel NCT00691002 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Calcipotriol | Small molecule | 25 unknown | Topical |
| Subject | Hydrocortisone | Other / unclassified | 10 unknown | Topical |