Journal of Clinical and Aesthetic Dermatology

MauiDerm 2017

An evidence-based, peer-reviewed journal for practicing clinicians in the field of dermatology

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S17 JCAD journal of clinical and aesthetic dermatology May 2017 • Volume 10 • Number 5 (Supplement 1) T SS. At Day15, both DFD-01 and A ugBD showed improved erythema (66.2% vs. 62.5%), scaling (70.7% vs. 62.5%), plaque elevation (65.4% vs. 62.5%), and TSS (53.4% vs. 43.8%). DFD- 01 reduced erythema and scaling in significantly more subjects than vehicle (p≤0.003) at Day 8 and DFD-01 reduced p laque elevation in more subjects than vehicle at Day 15 (p<0.001). DFD-01 and AugBD also demonstrated comparable efficacy for lesions located on the trunk or extremities on all measures except erythema, where DFD-01 improved erythema in significantly more subjects than AugBD on Day 4 (p=0.024). Conclusion: DFD-01, a topical formulation of betamethasone dipropionate 0.05% in an emollient-like spray improved lesions on knees and elbows. Improvements were seen in erythema, plaque elevation, scaling, and Total Sign Score (TSS). Responses were similar to those seen for lesions on other areas of the extremities and on the trunk. Financial diclosures/funding: This study was funded and sponsored by Promius Pharma, Princeton, NJ Disclosures: Dr. Kircik has received grants and/or honoraria from Abbott Laboratories, Aclaris, Acambis, Allergan, Inc., Amgen Inc., Anacor Pharmaceuticals, Assos Pharma, Astellas Pharma US, Inc, Asubio, Berlex Laboratories (Bayer Healthcare Pharmaceuticals), Biogen-Idec, Biolifes, Biopelle, Boehringer- Ingleheim, Breckinfidge Pharma, Colbar, Celgene, Centocor, Inc., CollaGenex, Combinatrix, Connetics Corp., Coria, Dermira, Dermick Laboratories, Dow Pharmaceutical Sciences, Inc., Galderma Laboratories, LP, Genentech, Inc., GlaxoSmithKline, PLC, HealthPoint, LTD, Idera, Intendis, Innocutis, Innovail, Johnson & J ohnson, Laboratory Skin Care, Inc., L eo, L'Oreal, 3M, Maruho, Medical International Technologies, Merck, Medicis Pharmaceutical Corp., Merz, Nano Bio, Novartis AG, Noven Pharmaceuticals, Nucryst Pharmaceuticals Corp, Obagi, OrthoNeutrogna, Promius Pharma, P ediaPharma, QLT, Inc., PharmaDerm, Pfizer, PuraCap, QAuinnova, Quatrix, Serono (Merck Serono International, SA, SkinMedica, Inc., Stiefel Laboratories, Inc., Taro, ToelrRx, Triax, UCB, valeant Pharmaceuticals Intl, Warner-Chilcott, XenoPort, and ZAGE. Dr. Bagel reports grants from Promius Pharma, during the conduct of the study; grants from Leo, grants from Celgene, grants from Abbvie, grants from BI, other from Novartis, other from Janssen, other from Valeant, other from Regeneron, other from Eli Lilly. A Phase 2, Multicenter, Double- blind, Randomized, Vehicle Controlled Clinical Study to Assess the Safety and Efficacy of a Halobetasol/Tazarotene Fixed Combination in the Treatment of Plaque Psoriasis Presenters: Linda Stein Gold, MD, 1 David M Pariser, MD, 2 Jeffrey L. Sugarman, MD, PhD, 3 Radhakrishnan Pillai, PhD 4 Affiliations: 1 Henry Ford Hospital, Detroit, MI; 2 Virginia Clinical Research, Inc., Norfolk, VA; 3 University of California, San Francisco, CA; 4 Dow Pharmaceutical Sciences Inc. (a division of Valeant Pharmaceuticals, North America LLC) Petaluma, CA Background: Psoriasis is a chronic, immune-mediated disease that varies widely in its clinical expression. Treatment options focus on relieving symptoms, reducing inflammation, induration, and scaling, and controlling the extent of the disease. The mainstay o f psoriasis treatment is a topical c orticosteroid; however, long-term safety remains a concern, particularly with the more potent formulations. Combination therapy with a corticosteroid and tazarotene may afford relief from inflammation, and a reduction in adverse events, such as s kin atrophy. Objective: To investigate the efficacy and safety of a once-daily application of a fixed combination halobetasol propionate 0.01% and tazarotene 0.045% (HP/TAZ) lotion in comparison with its monads and vehicle in subjects with moderate or severe plaque psoriasis. Methods: Multicenter, randomized, double-blind, vehicle-controlled Phase 2 study in moderate or severe psoriasis (N=212). Subjects randomized (2:2:2:1 ratio) to receive HP/TAZ, individual monads, or vehicle, once daily for eight weeks. Efficacy assessments included treatment success (defined as at least a 2-grade improvement from baseline in the IGA score and a score of "clear" or "almost clear"), and impact on individual signs of psoriasis at the target lesion. Safety and treatment emergent adverse events (TEAEs) was evaluated throughout. Results: HP/TAZ lotion demonstrated statistically significant superiority over vehicle as early as two weeks. At Week 8, 52.5 percent of subjects had treatment success compared with 33.3, 18.6, and 9.7 percent in the HP (p=0.033), TAZ (p<0.001), and vehicle (p<0.001) groups, respectively. HP/TAZ lotion was superior to its monads and vehicle in reducing the psoriasis signs of erythema, plaque elevation, and scaling. At Week 8, treatment success was achieved by 54.2 percent of subjects for erythema, 67.8 percent for plaque elevation, and 64.4 percent for scaling. Most frequently reported TEAEs were

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