Effect of Calcipotriol and Hydrocortisone in Patients with Psoriasis
EFFECT OF CALCIPOTRIOL PLUS HYDROCORTISONE OINTMENT ON THE HYPOTHALAMIC PITUITARY ADRENAL (HPA) AXIS AND CALCIUM METABOLISM IN PATIENTS WITH PSORIASIS VULGARIS ON THE FACE AND ON THE INTERTRIGINOUS AREAS.
Christopher E M Griffiths
LEO Pharma A/S
The development of study drug LEO 80190 ointment and this trial, is being funded by LEO Pharma A/S for the treatment of Psoriasis Vulgaris of the face and intertriginous areas i.e. armpits, groin, skin between the buttocks and the folds below the breasts. Psoriasis is a chronic inflammation of the skin. The disease progresses in episodes; during such an episode the skin is red and thickened, covered by silvery-white scales and often itchy. The drug being tested in this study is a combination of hydrocortisone 10 mg (an anti-inflammatory drug) and calcipotriol 0.025 mg (a substance similar to vitamin D). Both drugs are already marketed separately for the treatment of psoriasis. The main purpose of this clinical study is to look at the effect of once daily use of the study drug on adrenal hormone balance (adrenal hormones e.g. cortisone are produced by the body under stressful conditions) and calcium metabolism (calcium is the main component of our bones) when applied to the face and skin folds. Furthermore, safety and tolerability of the drug along with whether the study drug has an effect on the psoriasis of the face and skin folds will be investigated. Approximately 30 patients will be enrolled onto this study at sites in Germany, Canada, USA and two sites in the UK. Patients will have a screening visit, followed by 4-6 outpatient visits. The following procedures will be conducted during the trial; blood sampling, pregnancy testing, ECG (electrocardiogram), dermatological assessments of psoriasis, general health questions, applying study medication as prescribed and an ACTH challenge test. The ACTH challenge is a common test used to check the function of the cortisol hormone-system. It is anticipated that the trial will be completed by the end of 2009.
London - Harrow Research Ethics Committee
Date of REC Opinion
6 Oct 2008