Johnny Peppers1, Amy S Paller2, Tomoko Maeda-Chubachi3, Sterling Wu4, Kevin Robbins5, Kelly Gallagher4, John E Kraus6. 1. PRA Health Sciences, Raleigh, North Carolina. 2. Feinberg School of Medicine, Northwestern University, Chicago, Illinois. 3. Novan Inc, Morrisville, North Carolina. 4. GlaxoSmithKline, Collegeville, Pennsylvania. 5. GlaxoSmithKline, Collegeville, Pennsylvania. Electronic address: kevin.x.robbins@gsk.com. 6. ICON plc, Research Triangle Park, North Carolina.
Abstract
BACKGROUND: Safe and efficacious topical treatments are needed for atopic dermatitis (AD). OBJECTIVE: We assessed the safety and efficacy of tapinarof cream (2 concentrations and 2 application frequencies) in patients with AD. METHODS: A double-blind, vehicle-controlled, randomized, 6-arm trial (1:1:1:1:1:1) in patients age 12 to 65 years, with body surface area involvement of at least 5% to 35% and an Investigator's Global Assessment score of 3 or higher (moderate to severe) at baseline. Primary end points included an Investigator's Global Assessment score of clear or almost clear (0 or 1) and a minimum 2-grade improvement (treatment success) at week 12. Secondary analyses included a 75% or greater improvement in Eczema Area and Severity Index score, reduction of numeric rating scale (NRS) score for itch from baseline, and other prespecified end points. RESULTS: The rates of treatment success with tapinarof cream at week 12 were 53% (a concentration of 1% twice daily), 46% (a concentration of 1% once daily), 37% (a concentration of 0.5% twice daily), 34% (0.5% once daily), 24% (vehicle twice daily), and 28% (vehicle once daily). The rate with a concentration of 1% twice daily (53%) was statistically significantly higher than the rate with vehicle twice daily (24%). Treatment success was maintained for 4 weeks after the end of tapinarof treatment. The rate of treatment-emergent adverse events was higher with tapinarof (93 of 165 [56%]) than with vehicle (34 of 82 [41%]), and the events were mild to moderate in intensity. LIMITATIONS: Large confirmation trials are needed. CONCLUSIONS:Tapinarof cream is efficacious and well tolerated in adolescent and adult patients with AD.
RCT Entities:
BACKGROUND: Safe and efficacious topical treatments are needed for atopic dermatitis (AD). OBJECTIVE: We assessed the safety and efficacy of tapinarof cream (2 concentrations and 2 application frequencies) in patients with AD. METHODS: A double-blind, vehicle-controlled, randomized, 6-arm trial (1:1:1:1:1:1) in patients age 12 to 65 years, with body surface area involvement of at least 5% to 35% and an Investigator's Global Assessment score of 3 or higher (moderate to severe) at baseline. Primary end points included an Investigator's Global Assessment score of clear or almost clear (0 or 1) and a minimum 2-grade improvement (treatment success) at week 12. Secondary analyses included a 75% or greater improvement in Eczema Area and Severity Index score, reduction of numeric rating scale (NRS) score for itch from baseline, and other prespecified end points. RESULTS: The rates of treatment success with tapinarof cream at week 12 were 53% (a concentration of 1% twice daily), 46% (a concentration of 1% once daily), 37% (a concentration of 0.5% twice daily), 34% (0.5% once daily), 24% (vehicle twice daily), and 28% (vehicle once daily). The rate with a concentration of 1% twice daily (53%) was statistically significantly higher than the rate with vehicle twice daily (24%). Treatment success was maintained for 4 weeks after the end of tapinarof treatment. The rate of treatment-emergent adverse events was higher with tapinarof (93 of 165 [56%]) than with vehicle (34 of 82 [41%]), and the events were mild to moderate in intensity. LIMITATIONS: Large confirmation trials are needed. CONCLUSIONS:Tapinarof cream is efficacious and well tolerated in adolescent and adult patients with AD.