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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.

Journal of drugs in dermatology : JDD (2013-02-05)
Alan Menter, Linda Stein Gold, Michael Bukhalo, Steven Grekin, Steven Kempers, Brent M Boyce, Cecilia Ganslandt, John Villumsen, Mark Lebwohl
ABSTRACT

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. 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. 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. 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.

MATERIALS
Product Number
Brand
Product Description

Sigma-Aldrich
Calcipotriol hydrate, ≥98% (HPLC)
Sigma-Aldrich
Betamethasone, ≥98%
Sigma-Aldrich
Betamethasone 17,21-dipropionate
Supelco
Betamethasone, VETRANAL®, analytical standard
Betamethasone dipropionate, European Pharmacopoeia (EP) Reference Standard
Betamethasone, European Pharmacopoeia (EP) Reference Standard
Sigma-Aldrich
Betamethasone, meets USP testing specifications