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

Figure4Figure5(IGA) ratings of moderate or severe facial AV treated with TazF QD (n=744) or vehicle foam QD (n=741). Subjects were enrolled after confirming eligibility based on inclusion and exclusion criteria, including prior treatment washout periods, and with completion of conventional safety assessments and laboratory testing at baseline and throughout the study.33 Subjects applied study drug to the face with efficacy and safety outcomes assessed throughout the study, but were also allowed to treat upper truncal AV if present. Most randomized subjects presented with moderate severity (80%) with the remainder rated as severe (20%); mean lesion counts at baseline were 31.9 inflammatory (papules, pustules, ≤2 nodules), 47.8 non-inflammatory (comedonal), and 79.8 total AV lesions. Gender representation was essentially equal (51% male, 49% female), with 58% of subjects being adolescent (ages 12-17 years). Racial distribution was 77% White, 15% African-American, 4% Asian, and 4% other The primary efficacy endpoint was the percent of subjects achieving IGA of clear or almost clear with ≥2-grade improvement at EOT (week 12); percent reductions in lesion counts were also evaluated.33 Primary efficacy success achieved at week 12 was 28.2% in TazF-treated subjects and 14.7% in vehicle-treated subjects (P<.001).33 Figure 4 depicts mean % reductions in individual lesion counts, with significant decreases noted in both inflammatory and non-inflammatory (comedonal) lesions (P<.001 for both).33 Figure 5 shows the EOT outcome achieved in a subject treated with TazF.Local ASRs associated with TazF occurred early with peak incidence at week 2, followed by progressive improvement to baseline, consistent with what is anticipated historically with topical retinoid use.33 ASRs such as dermatitis, erythema, sting