Calcipotriene plus betamethasone dipropionate topical suspension for the
treatment of mild to moderate psoriasis vulgaris on the body: a randomized,
double-blind, vehicle-controlled trial.
Author(s): Menter A(1), Gold LS, Bukhalo M, Grekin S, Kempers S, Boyce BM, Ganslandt C,
Villumsen J, Lebwohl M.
Affiliation(s): Author information:
(1)Dermatology Department, Baylor University Medical Center, Dallas, TX, USA.
amderm@gmail.com
Publication date & source: 2013, J Drugs Dermatol. , 12(1):92-8
BACKGROUND/OBJECTIVES: A combination topical suspension/gel containing
calcipotriene plus betamethasone dipropionate has been developed as a safe and
effective treatment for patients with psoriasis vulgaris of the scalp. This same
preparation has the potential to be a convenient, effective, and cosmetically
appealing formulation for psoriasis on the body. This trial evaluated the
efficacy and safety of a topical suspension containing calcipotriene plus
betamethasone dipropionate compared with its constituent components and topical
suspension vehicle in the treatment of mild to moderate psoriasis on the trunk
and limbs.
METHODS: This was a randomized, double-blind, vehicle-controlled, 4-arm trial in
1,152 subjects. The co-primary efficacy end points were the proportion of
subjects achieving controlled disease based on the Investigators' Global
Assessment of disease severity at weeks 4 and 8. Adverse events, vital signs, and
clinical laboratory measurements were also assessed.
RESULTS: At week 4, a greater proportion of subjects in the calcipotriene plus
betamethasone group achieved controlled disease compared with subjects in the
calcipotriene-only and vehicle-only treatment groups. At week 8, a statistically
significantly (P<.01) greater proportion of subjects in the calcipotriene plus
betamethasone group achieved controlled disease compared with subjects in the 3
other treatment groups. Adverse events and other safety assessments were similar
between the groups.
CONCLUSION: The topical suspension containing calcipotriene plus betamethasone
dipropionate traditionally used for scalp psoriasis is also a safe and effective
once-daily treatment for psoriasis vulgaris on the body.
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