The percent of PP patients that achieved ≥1-point improvement [decrease in severity] from baseline on the overall POL severity scale of both lips together on day 84 was 66.7% with test device and 57.1% with comparator.
The change from baseline to day 84 in overall LFGS with both lips together in the PP population was 1.37 with test device and 1.42 with comparator (Figure 2).
The change from baseline to day 168 in overall LFGS of both lips together in the PP population was 1.00 with test device and 0.93 with comparator.
pGAI
In the PP population, the proportion of patients much improved or very much improved was greatest at day 56 for both groups (81% test device, 76% comparator) and lowest on day 168 (65% test device, 44% comparator). On day 84, the proportions improved, much improved, or very much improved for test device vs comparator were 96% vs 89%, respectively, and on day 168 were 93% vs 82%, respectively. The results for each category (improved, much improved, very much improved) are shown in Figures 3 through 5.
iGAI
For the PP population, the proportions of patients much improved or very much improved was greatest at day 56 for both groups (78% test device, 78% comparator) and lowest at day 168 (46% test device, 40% comparator). At day 28, the proportions of patients much improved or very much improved were 59% and
