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J Cutan Med Surg. 2016 Jan;20(1):44-51. doi: 10.1177/1203475415597094. Epub 2015 Jul 29.

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 information

1
The Derm Centre, Winnipeg, MB, Canada vhblackwood@shaw.ca.
2
Oshawa Clinic, Oshawa, ON, Canada.
3
LEO Pharma A/S, Ballerup, Denmark.
4
K Papp Clinical Research and Probity Medical Research, Waterloo, ON, Canada.

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.

KEYWORDS:

dermatology; psoriasis

PMID:
26224733
PMCID:
PMC4708614
DOI:
10.1177/1203475415597094
[Indexed for MEDLINE]
Free PMC Article

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