400 BOTE (Beginning Of The End) inflammation can be enhanced with SB206, a nitric oxide-releasing topical medication for molluscum contagiosum

Abstract

The beginning-of-the-end (“BOTE”) sign names inflammation that predicts imminent resolution of molluscum contagiosum (MC), but has never been prospectively studied. Integrated data from two phase 3, multicenter, randomized, double-blind, vehicle-controlled 12-week clinical trials of topical nitric oxide–releasing SB206 gel was used to evaluate an association between BOTE inflammation and MC lesion reduction among 707 randomized patients ≥6 months old. Investigators received training to evaluate BOTE components (erythema, edema, crusting, bullous reaction, erosion) using a 5-grade scoring system, and BOTE condition was scored prospectively during the study. Approximately 80% of patients exhibited BOTE inflammation at any time, regardless of treatment group. At week 12, initial MC lesion counts among vehicle-treated patients decreased by 50.7% from baseline for baseline BOTE+ vs 29.1% for baseline BOTE– patients (P =0 .0015). Among SB206-treated patients, MC lesion counts decreased by 63.3% from baseline for baseline BOTE+ vs 51.7% for baseline BOTE– (P =0 .0194). Among vehicle-treated patients, 48 (22.8%) who never developed BOTE inflammation during the 12-week study had an 18.5% reduction from baseline MC lesion counts vs a 34.0% reduction in 165 patients (76.7%) who experienced BOTE at any time during the study. This suggests a projected duration of 15 months until lesion clearance for BOTE– vs 6 months for BOTE+ patients. Those who were both BOTE+ and treated with SB206 had the greatest reduction in MC lesion count. SB206 may trigger BOTE inflammation and shorten the duration of MC infection.