Investigation of the Efficacy and Safety of
TO
‐208 in Patients 2 Years of Age or Older With Molluscum Contagiosum in Japan: A Randomized, Double‐Blind, Placebo‐Controlled, Phase 3 Study (208‐3‐1) an
Takafumi Kadono, Tsuyoshi Mitsuishi, Akira Shimizu, Yasushi Suga, Daisuke Watanabe, Shinya Kaneko, Ryota Ishiwata, Thomas F. Haws, Susan Cutler, Atsuyuki Igarashi ABSTRACT
Molluscum contagiosum (MC) is a common viral skin infection in children. In the two Phase 3 Cantharidin Application in Molluscum Patients [CAMP‐1 and CAMP‐2] studies, cantharidin, a drug‐device combination containing cantharidin (0.7%), a topical vesicant, was significantly superior to placebo in achieving complete clearance of MC lesions at the end of the study. The aim of this study was to evaluate the efficacy and safety of TO‐208, a drug‐device combination containing 0.7% w/v cantharidin, compared with a placebo in patients with MC in Japan. In this Phase 3, double‐blind study, patients aged ≥ 2 years with ≥ 5 MC lesions at baseline were randomly assigned (1:1 ratio) to the TO‐208 group or placebo group, with up to 4 applications every 21 days. The primary efficacy endpoint was the proportion of subjects with complete MC lesion clearance (baseline and new) at Day 85. The full analysis set was conducted for the efficacy population. The secondary efficacy outcome was the percentage change from baseline in the total number of MC lesions, including both baseline and newly developed lesions. The safety endpoints were adverse events and local skin reactions. In total, 148 subjects received TO‐208 and 155 received placebo. The proportion of subjects achieving complete clearance at Day 85 was significantly higher with TO‐208 compared to placebo 50.0% versus 23.2% ( p < 0.001). The percentage change in MC lesions from baseline to Day 85 was −88.35% versus −44.57% ( p < 0.001). Commonly reported adverse events with TO‐208 were mild or moderate blistering, pruritus, pain, and erythema at the application site. Overall, TO‐208 was significantly superior to the placebo in achieving complete clearance of MC lesions at the end of the study visit and was generally well tolerated, with adverse events that were predominantly mild to moderate in severity and limited to application sites.
Trial Registration: Japan Registry of Clinical Trials: jRCT2041220039