PSO-LONG: Design of a Novel, 12-Month Clinical Trial of Topical, Proactive Maintenance with Twice-Weekly Cal/BD Foam in Psoriasis

AbstractBackgroundPsoriasis vulgaris is commonly treated with topical corticosteroids and vitamin  D analogues. Although potent and super-potent topical corticosteroids are very effective at clearing psoriasis, with short-term reactive treatment durations, symptoms usually recur after treatment discontinuation, necessitating long-term disease management strategies. A foam formulation of calcipo triol and betamethasone dipropionate (Cal/BD foam), consisting of calcipotriol 50 μg/g and betamethasone dipropionate 0.5 mg/g, is approved for the daily treatment of psoriasis for up to 4 weeks. Here, we describe a clinical trial protocol for evaluating the long-term safety and efficacy of twic e-weekly Cal/BD foam as a proactive topical maintenance therapy for plaque psoriasis for up to 52 weeks.ObjectiveThe aim of this trial was to evaluate the safety and efficacy of Cal/BD foam when applied twice weekly for up to 52  weeks as proactive maintenance therapy, with the goal of preventing or delaying disease relapse as long as possible while minimizing adverse effects.MethodsOnce-daily Cal/BD foam treatment responders from an initial 4-week open-label period were randomized to receive Cal/BD foam or foam vehicle applied to previously cleared plaques twice weekly for up to 52  weeks. In case of relapse, affected subjects in either group received rescue therapy with once-daily Cal/BD foam for 4 weeks on active areas. Thus, the trial (NCT02899962) compared the long-term use of Cal...
Source: Advances in Therapy - Category: Drugs & Pharmacology Source Type: research