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J Dermatolog Treat. 2016;27(2):120-7. doi: 10.3109/09546634.2015.1083935. Epub 2015 Oct 7.

Superior efficacy of calcipotriene and betamethasone dipropionate aerosol foam versus ointment in patients with psoriasis vulgaris--A randomized phase II study.

Author information

1
a Department of Dermatology , University of California , San Francisco , San Francisco , CA , USA .
2
b Department of Dermatology , University of Texas Health Science Center , Houston , TX , USA .
3
c University of Washington School of Medicine , Seattle , WA , USA .
4
d Suzanne Bruce and Associates, PA , Houston , TX , USA .
5
e LEO Pharma A/S , Ballerup , Denmark , and.
6
f Psoriasis Treatment Center of Central New Jersey , East Windsor , NJ , USA.

Abstract

BACKGROUND:

An aerosol foam formulation of fixed combination calcipotriene 0.005% (as hydrate; Cal) plus betamethasone dipropionate 0.064% (BD) was developed to improve psoriasis treatment.

OBJECTIVES:

To compare the efficacy and safety of Cal/BD aerosol foam with Cal/BD ointment after 4 weeks.

METHODS:

In this Phase II, multicenter, investigator-blind, 4-week trial, adult patients with psoriasis vulgaris were randomized to Cal/BD aerosol foam, Cal/BD ointment, aerosol foam vehicle or ointment vehicle (3:3:1:1). The primary efficacy endpoint was the proportion of patients at week 4 who achieved treatment success (clear or almost clear with at least a two-step improvement) according to the physician's global assessment of disease severity.

RESULTS:

In total, 376 patients were randomized. At week 4, significantly more patients using Cal/BD aerosol foam achieved treatment success (54.6% versus 43.0% [ointment]; p = 0.025); mean modified (excluding the head, which was not treated) psoriasis area and severity index score was significantly different between Cal/BD aerosol foam and Cal/BD ointment (mean difference -0.6; p = 0.005). Rapid, continuous itch relief occurred with both active treatments. One adverse drug reaction was reported with Cal/BD aerosol foam (application site itch).

CONCLUSIONS:

Cal/BD aerosol foam demonstrates significantly greater efficacy and similar tolerability compared with Cal/BD ointment for psoriasis treatment.

KEYWORDS:

Aerosol foam; betamethasone dipropionate; calcipotriene; psoriasis vulgaris; topical treatments

PMID:
26444907
PMCID:
PMC4772687
DOI:
10.3109/09546634.2015.1083935
[Indexed for MEDLINE]
Free PMC Article

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