concentrations on day 15. A 5-year-old white male (20.0 kg, with 31 baseline molluscum lesions, 6.05% of BSA treated) had a single quantifiable concentration of 5.12 ng/mL at 2 hours post-application, close to the LLOQ of 5 ng/mL. An 11-year old white female weighing 42.2 kg who had 48 molluscum lesions at baseline and 3.69% of BSA treated had 4 quantifiable concentrations (10.4, 20.8, 33.9, and 22.5 ng/mL on day 15 preapplication, 1-, 3-, and 6-hours post-application, respectively). Her AUC0-3 was 75.5 h*ng/mL; however, plasma hMAP3 concentrations fell below the LLOQ by week 12. Mean nitrate plasma concentration–time data by age group are displayed in Figure 1. In general, mean nitrate concentration– time profiles (non-baseline corrected) were similar on days 1 and 15 and remained relatively flat throughout the sampling interval.
Mean plasma nitrate concentrations were slightly higher in younger patients (<6 years) on day 15, with mean concentrations ranging from 1400 to 1730 ng/mL, compared with older patients (≥6 years), for whom mean concentrations ranged from 1200 to 1410 ng/mL. The 2 patients with measurable hMAP3 levels also exhibited relatively flat nitrate levels from day 1 to 15.
Safety
Overall, 37 TEAEs were reported for 16 of 34 (47.1%) patients (Table 2). The most frequently reported TEAEs were applicationsite pain (13/34 [38.2%]) and application-site erythema (6/34 [17.6%]), mostly mild or moderate in severity. TEAEs of application-site scar were reported in 5 patients, and all were considered mild in severity. No patients formed keloid or hypertrophic scars. Fifteen patients had ≥1 TEAE related to berdazimer gel, 10.3%, with the most frequently reported being application-site pain (13/15 [86.7%]). Severe TEAEs were reported in only 3 patients, all application-site pain and probably medication related. There were no serious TEAEs, TEAEs leading to treatment discontinuation, or deaths.
Tolerability
Overall, mean LSR composite scores peaked by week 2, then
