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Multicenter Study
. 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

Victoria Taraska  1 , Raj Tuppal  2 , Martin Olesen  3 , Claus Bang Pedersen  3 , Kim Papp  4
Affiliations
Multicenter Study

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

Victoria Taraska et al. J Cutan Med Surg. 2016 Jan.

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.

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Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Dr Taraska has been a speaker/investigator for LEO Pharma, Basilea, Amgen, Galderma, AbbVie, Allergan, Cipher, and Valeant. Dr Tuppal has been a speaker/investigator for Amgen, Pfizer, LEO Pharma, Galderma, Valeant, Novartis, and Schering (MSD). Dr Olesen and Dr Bang Pedersen are employees of LEO Pharma. Dr Papp has been a consultant for Janssen, Johnson & Johnson, Kirin, Kyowa, LEO Pharma, Lypanosys, Merck, Mitsubishi Pharma, Novartis, Pan Genetics, Pfizer, Roche, Merck Serono, Takeda, UCB, and Vertex; a speakers’ bureau member for Janssen, Merck, Novartis, and Pfizer; an investigator for Janssen, Kyowa, LEO Pharma, Merck, Novartis, Pfizer, Stiefel, and Takeda; a speaker for Janssen, Kyowa, Lypanosys, Merck, Mitsubishi Pharma, Novartis, Pfizer, Merck Serono, Takeda, UCB, Vertex, and Wyeth; a steering committee member for Janssen, Kirin, Kyowa, Merck, Novartis, and Pfizer; and an advisory board member for Janssen, Merck, Novartis, Pfizer, and UCB.

Figures

Figure 1.
Figure 1.
Serum cortisol levels 30 minutes after adrenocorticotropic hormone (ACTH) challenge test at week 4 versus average weekly drug use. Data are from patients who completed the study per protocol and with drug usage data (n = 32). The cortisol assay used was the Siemens ADVIA Centaur XP.
Figure 2.
Figure 2.
Individual patient (a) albumin-corrected serum calcium values, (b) 24-hour urinary calcium levels, and (c) urinary calcium-creatinine ratios at screening visit 2 (ie, baseline) and at week 4. Data not shown for patients who discontinued after 2 weeks of treatment.
Figure 3.
Figure 3.
Percentage of patients in each category of the Physician’s Global Assessment of Disease Severity at baseline, week 2, and week 4.
See this image and copyright information in PMC

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