A Novel Aerosol Foam Formulation of Calcipotriol and Betamethasone Has No Impact on HPA Axis and Calcium Homeostasis in Patients With Extensive Psoriasis Vulgaris.

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 homeost

SUBMITTER: Taraska V 

PROVIDER: S-EPMC4708614 | biostudies-literature | 2016 Jan

REPOSITORIES: biostudies-literature