Pharmacology
Pharmacodynamics
A number of clinical studies have been conducted to research possible adverse effects of this drug combination, which can be expected from experiences with corticosteroids and vitamin D analogs. Hypothalamic-pituitary-adrenal axis suppression
In a small study of calcipotriol/betamethasone dipropionate (Cal/BD) ointment once-daily for 4 weeks, no patients (N=11 tested) demonstrated adrenal suppression defined as 30-minute post-stimulation cortisol level ≤18 mcg/dL. In two other studies of Cal/BD ointment, 1 patient of 19 (5.3%) had adrenal suppression, as did 5 patients of 32 (15.6%) after 4 weeks of treatment. In the latter study, it may be noted that patients used Cal/BD ointment on the body in addition to Cal/BD topical suspension on the scalp.Potential effects on hypothalamic-pituitary-adrenal (HPA axis) function of the foam formulation were evaluated in a clinical trial of adults (N=35) with moderate to severe plaque psoriasis covering a mean of 18% of the body surface area of the trunk and limbs and 50% of the scalp. The foam was applied once daily to all lesions on the trunk, limbs and scalp for 4 weeks. Mean (range) weekly exposure was 62 (13.5–113) g. After 4 weeks, no patient exhibited adrenal suppression, defined as a cortisol level ≤497 nmol/L 30 minutes after adrenocorticotropic hormone challenge. Lack of adrenal suppression over the course of four weeks does not preclude the possibility of HPA axis suppression during prolonged exposure.
Contraindications
Calcipotriol/betamethasone dipropionate is contraindicated in patients with hypersensitivity to either glucocorticoids or vitamin D or disorders in calcium metabolism. This drug is also contraindicated for patients with erythrodermic, exfoliative, or pustular psoriasis. Adverse effects
A number of clinical studies have been conducted to investigate possible adverse events of this fixed combination corticosteroid and vitamin D analog. Safety and tolerability of calcipotriol/betamethasone dipropionate (Cal/BD) ointment has been assessed in a combined total of 2448 patients, exposed to treatment for 4 or 8 weeks (median weekly dose of 24.5 g). The most common adverse events for patients receiving Cal/BD were pruritus (3.1%), headache (2.8%), and nasopharyngitis (2.3%). Lesional/perilesional adverse events, defined as an adverse event located ≤2 cm from the lesional border, were reported by 8.7% of patients treated with Cal/BD ointment. Median time to onset of lesional/perilesional adverse events was 7 days.Adverse events during treatment with the foam formulation have been evaluated in three 4-week randomized, multicenter, prospective vehicle- and/or active-controlled clinical trials of subjects with plaque psoriasis. The median weekly dose was 24.8 g. Application site irritation, application site pruritus (itching), folliculitis (inflammation of hair follicles), skin hypopigmentation (loss of skin color), hypercalcemia (increased blood calcium levels), urticaria, and exacerbation of psoriasis were reported in <1% of subjects. Local long-term adverse effects of continuous steroid exposure may include skin atrophy, stretch marks, telangiectasia (spider veins), dryness, local infections, and miliaria ("prickly heat").