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.
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 physicians 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.
The Journal of clinical and aesthetic dermatology