The Clinical Relevance and Therapeutic Benefit of Established Active Ingredients Incorporated into Advanced Foam Vehicles: Vehicle Characteristics Can Influence and Improve Patient Outcomes

February 2019 | Volume 18 | Issue 2 | Supplement Individual Articles | 100 | Copyright © February 2019

James Q. Del Rosso DO,Ma Leon Kircik MD,b Joshua Zeichner MD,c Linda Stein Gold MDd

aJDR Dermatology Research/Thomas Dermatology, Las Vegas, NV; Touro University, Henderson, NV bIcahn School of Medicine at Mount Sinai, New York, NY cIcahn School of Medicine at Mount Sinai, New York, NY dHenry Ford Hospital, Detroit, MI

Figure1Calcipotriene 0.005% Foam for Plaque Psoriasis Calcipotriene is a structural analog of vitamin D3, exhibiting similar keratinocyte receptor binding capacity but with 100- fold lower potency of effect on calcium metabolism, likely due to its more rapid cutaneous metabolism.34,35 Improvement of psoriasis after topical application of calcipotriene appears to relate to inhibition of keratinocyte proliferation, improved keratinocyte differentiation and modulation of T lymphocyte proliferation.34,35 Calcipotriene for psoriasis has been used successfully as monotherapy and also sequentially with TCS, contributing to reduced TCS side effects and longer periods of disease remission.34-37 Calcipotriene Foam Studies Calcipotriene 0.005% foam (CalcipF) is approved by the Food and Drug Administration (FDA) for topical treatment of plaque psoriasis of the scalp and body in patients greater than equal to 18 years of age; a thin layer is to be applied into affected areas twice daily (BID).24 Studies were performed in both body psoriasis and scalp psoriasis using conventional inclusion/exclusion/washout criteria and safety assessments including laboratory testing.27 The CalcipF was packaged in aluminum cans pressurized with a propane/butane propellant, with vehicle foam identically packaged except for absence of the active ingredient. Notably, twenty-one adolescent subjects (ages 12-17 years) were included collectively in the body and scalp studies, with this number of subjects too low for the FDA to grant approval down to age 12 years. As discussed earlier, CalcipF is an aqueous-based emulsion foam that is devoid of ethanol, preservatives, and fragrances.24 Patient assessments of clinically relevant foam characteristics will be discussed later in this article.Body Plaque Psoriasis Two 8-week, randomized, controlled, double-blind trials (RCTs) were completed in subjectsg greater than equal to 12 years of age treated with CalcipF BID (n=437) or vehicle BID (n=222) with mild to moderate body plaque psoriasis affecting the trunk and/or extremities (N=659); 71% were rated as moderate and 29% as mild based on Investigator Static Global Assessment (ISGA).27 The mean body surface area (BSA) affected was 6.3% (range, 2%-20%). Target lesions were also assessed. Both genders were equally represented (54% male; 46% female). The primary efficacy endpoint was percent subjects achieving ISGA of clear or almost clear with a greater than equal to 2-grade improvement at end of treatment (EOT/ week 8).Primary endpoint success in Study 1 was achieved by 14% and 7% of subjects in the CalcipF group and vehicle group, respectively (P=0.058), which included a higher number of baseline ISGA mild subjects (31.8%). In Study 2, endpoint success wasFigure2