1. A Novel Aerosol Foam Formulation of Calcipotriol and Betamethasone Has No Impact on HPA Axis and Calcium Homeostasis in Patients With Extensive Psoriasis Vulgaris.
- Author
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Taraska V, Tuppal R, Olesen M, Bang Pedersen C, and Papp K
- Subjects
- Aerosols, Calcitriol administration & dosage, Drug Combinations, Female, Homeostasis, Humans, Hypothalamo-Hypophyseal System drug effects, Male, Middle Aged, Pituitary-Adrenal System drug effects, Psoriasis physiopathology, Betamethasone administration & dosage, Calcitriol analogs & derivatives, Calcium metabolism, Dermatologic Agents administration & dosage, Psoriasis drug therapy
- Abstract
Background: Fixed combination calcipotriol 50 µg/g (Cal; as hydrate) plus betamethasone 0.5 mg/g (as dipropionate; BD) has been formulated in an innovative aerosol foam., Objective: To assess systemic safety of Cal/BD aerosol foam., Methods: In a multicentre, single-arm, open-label, maximal-use systemic-exposure trial, adult patients with moderate to severe, extensive psoriasis (15%-30% of body surface area, including ≥30% of scalp) applied Cal/BD foam once daily. Endpoints were week 4 abnormal adrenocorticotropic hormone (ACTH) challenge test and change in albumin-corrected serum calcium, 24-hour urinary calcium excretion, and urinary calcium-creatinine ratio., Results: 35 patients reaching week 4 exhibited normal ACTH responses. At week 4, changes in calcium homeostasis were minor and not clinically relevant; no patients experienced elevations above normal. Disease severity generally improved, and 49% of patients achieved treatment success according to the Physician's Global Assessment of Disease Severity., Conclusion: No clinically relevant HPA axis or calcium homeostasis impact was observed with 4 weeks of once-daily Cal/BD foam in patients with extensive psoriasis vulgaris., (© The Author(s) 2015.)
- Published
- 2016
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