Dermal Safety of Tapinarof Cream 1%: Results From 4 Phase 1 Trials

October 2022 | Volume 21 | Issue 10 | 1084 | Copyright © October 2022


Published online September 22, 2022

John E. Jett PhD, Michael McLaughlin MS MSE, Timothy Wilson MS, Matthew C. Somerville MS, Wayne DellaMaestra MCS, David S. Rubenstein MD PhD, Stephen C. Piscitelli PharmD

Dermavant Sciences, Inc., Morrisville, NC



response scores than the non-irradiated sites. Statistically significant differences in the mean dermal response score were observed between tapinarof cream 1% irradiated and tapinarof cream 1% non-irradiated sites (P=0.0014), as well as between vehicle irradiated and vehicle non-irradiated sites (P=0.0044).

Additional Safety Measures
A low incidence of AEs was reported across the 4 trials (Table 5). All AEs occurred in the photoallergy trial and none was considered related to tapinarof cream 1%. Four participants (6.9%) in the photoallergy trial experienced 5 treatmentemergent AEs (TEAEs); 2 were mild in severity (urinary tract infection and headache), 1 was moderate (nausea), and 2 were severe (nephrolithiasis and ligament sprain). Two participants discontinued the study due to AEs.