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).


METHODS
Patients were randomized (100:101:101) to receive Cal/BD foam, Cal foam, or BD foam once daily for four weeks.


METHODS
Twenty-eight United States centers.


METHODS
302 patients (≥18 years) with Psoriasis vulgaris (plaque Psoriasis; ≥mild disease severity by physicians global assessment).


METHODS
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.


CONCLUSIONS
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.


BACKGROUND
NCT01536938.
Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York;
Mark
M
Lebwohl
Department of Dermatology, University of Texas, Houston, Texas;
Stephen
S
Tyring
Altman Dermatology Associates, Arlington Heigrits, Illinois;
Michael
M
Bukhalo
Department of Dermatology, VA Medical Center, Miami, Florida;
Javier
J
Alonso-Llamazares
LEO Pharma A/S, Ballerup, Denmark;
Martin
M
Olesen
LEO Pharma A/S, Ballerup, Denmark;
David
D
Lowson
Dermatology Institute and Skin Care Center, Santa Monica, California.
Paul
P
Yamauchi