SB206, a Nitric Oxide–releasing Topical Medication Induces the BOTE (Beginning-of-the-End) Sign and Molluscum Clearance

ABSTRACT The beginning-of-the-end “BOTE” sign has been proposed to describe well-recognized clinical signs of inflammation (including erythema, induration, and scale) that predict imminent resolution of molluscum contagiosum (MC). This phenomenon has never been prospectively studied. An integrated analysis of 2 prospective, 12-week, randomized, double-blind clinical trials of topical nitric oxide–releasing SB206 gel evaluated an association between BOTE sign and MC lesion reduction. Of 707 randomized patients, ∼80% exhibited BOTE sign regardless of treatment assignment. At week 12, MC lesion counts decreased from baseline by 50.7% for baseline BOTE+ vs 29.1% for BOTE– vehicle patients (P = .0015) compared with a 63.3% decrease for baseline BOTE+ vs 51.7% for BOTE– (P = .0194) SB206 patients. Among vehicle patients, 48 (22.3%) who were never BOTE+ had an 18.5% reduction from baseline in MC lesion counts vs a 34.0% reduction in 165 patients (76.7%) who experienced BOTE at any time, suggesting the projected duration of lesion clearance for patients with 18–20 MC lesions is 15 months for BOTE– vs 6 months for BOTE+. Patients who were both BOTE+ and treated with SB206 had the greatest reduction in MC lesion count. SB206 may trigger BOTE sign and shorten the duration of MC infection.