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
January 2013 | Volume 12 | Issue 1 | Original Article | 92 | Copyright © 2013
Alan Menter MD,a Linda Stein Gold MD,b Michael Bukhalo MD,c Steven Grekin DO,d Steven Kempers MD,e Brent M. Boyce MD,f Cecilia Ganslandt MD, gJohn Villumsen MSc,h and Mark Lebwohl MDi
aDermatology Department, Baylor University Medical Center, Dallas, TX bDepartment of Dermatology, Henry Ford Health System, Detroit, MI cAltman Dermatology Associates, Arlington Heights, IL dGrekin Skin Institut
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.
J Drugs Dermatol. 2013;12(1):92-98.
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Psoriasis is a multisystem disease with predominantly skin and joint manifestations, affecting approximately 2% of the population.1 It is characterized by well-demarcated, erythematous, scaly plaques, which are often itchy. Psoriasis vulgaris (plaque-type psoriasis) is the most common clinical type, affecting approximately 80% of patients.1 Psoriasis is associated with multiple physical and psychiatric comorbidities, including metabolic syndrome, cardiovascular disease, depression, and impairment of social and/or work functioning and quality of life (QOL).1-3
Current treatment options for psoriasis include topical therapies, phototherapy, photochemotherapy (PUVA), and systemic and biologic agents. The majority of patients have mild to moderate disease, which can be controlled with appropriate topical agents.4 Topical agents are also frequently used as adjunctive therapy in patients with more extensive disease who are being treated with other therapy modalities.4 Vitamin D analogues and topical steroids are the most commonly used topical agents and are well tolerated and safe when used appropriately.5
A 2-compound ointment containing 50 μg/g calcipotriene plus 0.5 mg/g betamethasone (as dipropionate) has shown good efficacy and safety in the treatment of psoriasis vulgaris on the body.6 The active ingredients provide a dual mechanism of action and have minimal systemic absorption when used appropriately. The skin irritation sometimes noted with calcipotriene monotherapy is reduced by the presence of betamethasone, while the addition of calcipotriene to betamethasone has the potential of steroid-sparing benefits.4 In some patients, ointments are unacceptably greasy and messy to use, resulting in decreased adherence to the treatment regimen.7 Therefore, there is an ongoing need to develop more acceptable formulations that better meet patients’ needs and wishes and increase adherence to the prescribed treatment regimen.