By Jill Stein
SAN FRANCISCO -- March 9, 2009 -- Clobetasol propionate (CP) 0.05% spray followed by calcitriol ointment is effective and well tolerated for the management of moderate to severe plaque psoriasis, researchers stated here at the American Academy of Dermatology (AAD) 67th Annual Meeting.
Mark Lebwohl, MD, Dermatology Division, Mount Sinai School of Medicine, New York, New York, and colleagues presented the results of the multicentre, open-label study here on March 6 in a poster presentation.
Topical therapy has been the first-line of defence against psoriasis, but there is currently a shift from a focus on short-term treatment of disease outbreaks to maintenance of long-term control, researchers explained.
The researchers therefore tested the efficacy and safety of a consecutive treatment regimen of twice-daily CP spray for up to 4 weeks followed by twice-daily calcitriol ointment 3 mcg/g for up to 8 weeks.
The study enrolled 300 patients but the researcher presented results of an analysis of 161 patients that made up the modified intent-to-treat population.
Overall, 119 (73.9%) patients achieved treatment success after 12 weeks of treatment. Treatment success was defined as at least 1 grade improvement in the overall disease severity score from baseline to week 12.
The treatment regimen was generally well tolerated with 91 adverse events reported in 49 patients (27.8%) at the time of the interim analysis. Of these, about 33% were severe and 16.5% were thought to be possibly or likely related to the study medication.
The most commonly reported cutaneous irritations were mild to moderate pruritus, stinging and burning, and telangiectasia. There were no cases of skin atrophy, and folliculitis was present in 1 patient in the safety population at week 12 compared with 2 reports at enrolment.
The results of the study combined with results from earlier trials support the use of a consecutive treatment regimen of CP spray followed by calcitriol ointment for moderate to severe plaque psoriasis, the researchers concluded.
The study was supported by Galderma Laboratories, L.P.
[Presentation title: A Consecutive Treatment Regimen of Clobetasol Propionate 0.05% Spray Followed by Calcitriol Ointment 3 mcg/g for the Management of Moderate to Severe Plaque Psoriasis. Abstract P3362]
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