ratio of females to males in each treatment group, and there was a higher percentage of subjects aged 12 - 17 years in the vehicle group. Total baseline lesion counts were high, averaging 98.5±39.0intheA/BPOgel0.3%/2.5%groupand97.6±36.6inthe vehicle group. Baseline inflammatory and noninflammatory lesion counts were comparable across groups (Table 1). Efficacy by Gender
Success rates were significantly superior with A/BPO gel 0.3%/2.5% compared to vehicle at week 12 in both males (P=0.039) and females (P=0.009; Figure 1). As shown in Figure 2, there were comparable lesion count reductions at week 12 in acne lesions among both males and females, with statistically significantly superior reductions in all cases (P<0.001) compared with vehicle. As shown, the improvements were greatest among those with the most severe acne (IGA 4) at baseline. Males in the A/BPO gel 0.3%/2.5% group experienced a mean -64.5% change in noninflammatory lesions (vs -33.3% change for the vehicle group; P<0.001; Figure 3A) and females experienced a mean -60.8%% change (vs -32.4% change in the vehicle group, P<0.001; Figure 3A) at week 12 (LOCF). For inflammatory lesions, males in the A/BPO gel 0.3%/2.5% group experienced a mean -62.6% change (vs -32.8% change for the vehicle group, P<0.001; Figure 3B) and females experienced a mean -62.9%% change (vs -36.7% change in the vehicle group, P<0.001; Figure 3B) at week 12 (LOCF).
Efficacy by Age
Figure 4 presents the lesion reduction stratified by age (12-17 vs ≥18 years). Both age groups exhibited significant reductions from baseline in mean noninflammatory and inflammatory lesions when A/BPO gel 0.3%/2.5% treatment was compared with vehicle at week 12. Again, A/BPO gel 0.3%/2.5% treatment showed greater efficacy in subjects with more severe acne (IGA 4) at baseline. Subjects age 12–17 years old in the A/BPO gel 0.3%/2.5% group experienced a mean -62.7%
