PSO-LONG: Design of a Novel, 12-Month Clinical Trial of Topical, Proactive Maintenance with Twice-Weekly Cal/BD Foam in
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PSO-LONG: Design of a Novel, 12-Month Clinical Trial of Topical, Proactive Maintenance with Twice-Weekly Cal/BD Foam in Psoriasis Linda Stein Gold . Javier Alonso-Llamazares . Jean-Philippe Lacour . Richard B. Warren . Stephen K. Tyring . Leon Kircik . Paul Yamauchi . Mark Lebwohl
Received: July 28, 2020 / Accepted: September 3, 2020 Ó The Author(s) 2020
ABSTRACT Background: Psoriasis vulgaris is commonly treated with topical corticosteroids and vitamin D analogues. Although potent and superpotent topical corticosteroids are very effective at clearing psoriasis, with short-term reactive treatment durations, symptoms usually recur
Digital Features To view digital features for this article, go to https://doi.org/10.6084/m9.figshare.12834647. Electronic supplementary material The online version of this article (https://doi.org/10.1007/s12325020-01497-6) contains supplementary material, which is available to authorized users. L. Stein Gold Department of Dermatology, Henry Ford Health System, Detroit, MI, USA
after treatment discontinuation, necessitating long-term disease management strategies. A foam formulation of calcipotriol and betamethasone dipropionate (Cal/BD foam), consisting of calcipotriol 50 lg/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 twice-weekly Cal/BD foam as a proactive topical maintenance therapy for plaque psoriasis for up to 52 weeks. Objective: The aim of this trial was to evaluate the safety and efficacy of Cal/BD foam when L. Kircik Icahn School of Medicine at Mount Sinai, New York, NY, USA L. Kircik Indiana University School of Medicine, Indianapolis, IN, USA
J. Alonso-Llamazares Department of Dermatology, VA Medical Center, Miami, FL, USA
L. Kircik Physicians Skin Care, PLLC, Louisville, KY, USA
J.-P. Lacour Department of Dermatology, University Hospital of Nice, Nice, France
P. Yamauchi Division of Dermatology, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA
R. B. Warren Dermatology Centre, Salford Royal NHS Foundation Trust, NIHR Manchester BRC University of Manchester, Manchester, UK
M. Lebwohl (&) Icahn School of Medicine at Mount Sinai, New York, NY, USA e-mail: [email protected]
S. K. Tyring Department of Dermatology, University of Texas Health Science Center, Houston, TX, USA
Adv Ther
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. Methods: Once-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/BD foam
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