Fixed combination aerosol foam calcipotriene 0.005% (Cal) plus betamethasone dipropionate 0.064% (BD) is more efficacious than Cal or BD aerosol foam alone for psoriasis vulgaris: A randomized, double-blind, multicenter, three-arm, phase 2 study

Mark Lebwohl, Stephen Tyring, Michael Bukhalo, Javier Alonso-Llamazares, Martin Olesen, David Lowson, Paul Yamauchi

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81 Scopus citations

Abstract

Objective: To evaluate the efficacy of fixed combination aerosol foam calcipotriene 0.005% (cal) plus betamethasone dipropionate 0.064% (BD). Design: Patients were randomized (100:101:101) to receive cal/BD foam, cal foam, or BD foam once daily for four weeks. Setting: Twenty-eight United states centers. Participants: 302 patients (≥18 years) with psoriasis vulgaris (plaque psoriasis; ≥mild disease severity by physician's global assessment). Measurements: Treatment success of the body ("clear"/"almost clear" from baseline moderate/severe disease; "clear" from baseline mild disease). involved scalp treatment success was an additional endpoint. Results: Most patients (76%) had moderate psoriasis of the body (66% for scalp). at Week 4, 45 percent of cal/BD foam patients achieved treatment success, significantly more than cal foam (14.9%; or 4.34 [95%ci 2.16, 8.72] P<0.001) or BD foam (30.7%; 1.81 [1.00, 3.26] P=0.047). Fifty-three percent of cal/BD foam patients achieved treatment success of the scalp, significantly greater than cal foam (35.6%; 1.91 [1.09, 3.35] P=0.021), but not BD foam (47.5%; 1.24 [0.71, 2.16] P=0.45). Mean modified psoriasis area and severity index (population baseline 7.6) improved in all groups, with statistically significant differences in Week 4 cal/BD foam score (2.37) versus cal foam (4.39; mean difference -2.03 [-2.63, -1.43] P<0.001) and BD foam (3.37; -1.19 [-1.80, -0.59] P<0.001). Four (cal/BD), 10 (cal), and 8 (BD) adverse drug reactions were reported. Conclusion: cal/BD foam was significantly more effective than cal foam and BD foam in providing treatment success at Week 4 and effective on involved scalp. Trial registration: ncT01536938.

Original languageEnglish
Pages (from-to)34-41
Number of pages8
JournalJournal of Clinical and Aesthetic Dermatology
Volume9
Issue number2
StatePublished - Feb 2016

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