Table 5.
Anti-SA Activity – PD Population
| XF-73 in 2% Gel 0.5 mg/g (N = 11) | XF-73 in 2% Gel 2.0 mg/g (N = 13) | XF-73 in 4% Gel 0.5 mg/g (N = 12) | All Active Treatments (N = 36) | Placebo in 4% Gel (N = 12) | |
|---|---|---|---|---|---|
| Day 1: Absence of SA Colonization | |||||
| No | 10 (90.9%) | 13 (100.0%) | 12 (100.0%) | 35 (97.2%) | 11 (91.7%) |
| Yes | 1 (9.1%) | 0 | 0 | 1 (2.8%) | 1 (8.3%) |
| p-value vs. Placebo | 0.7391 | 1.0000 | 1.0000 | 0.9415 | n/a |
| Day 2: Positive Response to Treatment | |||||
| No | 4 (36.4%) | 5 (38.5%) | 6 (50.0%) | 15 (41.7%) | 9 (75.0%) |
| Yes | 7 (63.6%) | 8 (61.5%) | 6 (50.0%) | 21 (58.3%) | 3 (25.0%) |
| p-value vs. Placebo | 0.0736 | 0.0749 | 0.2002 | 0.0467 | n/a |
| Day 3: Positive Response to Treatment | |||||
| No | 5 (45.5%) | 6 (46.2%) | 6 (50.0%) | 17 (47.2%) | 8 (66.7%) |
| Yes | 6 (54.5%) | 7 (53.8%) | 6 (50.0%) | 19 (52.8%) | 4 (33.3%) |
| p-value vs. Placebo | 0.2735 | 0.2655 | 0.3401 | 0.2028 | n/a |
| Day 4: Positive Response to Treatment | |||||
| No | 5 (45.5%) | 6 (46.2%) | 5 (41.7%) | 16 (44.4%) | 7 (58.3%) |
| Yes | 6 (54.5%) | 7 (53.8%) | 7 (58.3%) | 20 (55.6%) | 5 (41.7%) |
| p-value vs. Placebo | 0.4211 | 0.4179 | 0.3421 | 0.3084 | n/a |
| Day 5: Positive Response to Treatment | |||||
| No | 4 (36.4%) | 5 (38.5%) | 5 (41.7%) | 14 (38.9%) | 6 (50.0%) |
| Yes | 7 (63.6%) | 8 (61.5%) | 7 (58.3%) | 22 (61.1%) | 6 (50.0%) |
| p-value vs. Placebo | 0.4067 | 0.4296 | 0.5000 | 0.3649 | n/a |
| Day 6: Positive Response to Treatment | |||||
| No | 4 (36.4%) | 6 (46.2%) | 7 (58.3%) | 17 (47.2%) | 7 (58.3%) |
| Yes | 7 (63.6%) | 7 (53.8%) | 5 (41.7%) | 19 (52.8%) | 5 (41.7%) |
| p-value vs. Placebo | 0.2632 | 0.4179 | 0.6599 | 0.3700 | n/a |
| Day 14: Positive Response to Treatment | |||||
| No | 5 (45.5%) | 12 (92.3%) | 12 (100.0%) | 29 (80.6%) | 11 (91.7%) |
| Yes | 6 (54.5%) | 1 (7.7%) | 0 | 7 (19.4%) | 1 (8.2%) |
| p-value vs. Placebo | 0.0240 | 0.7800 | 1.0000 | 0.3457 | n/a |
n/a = not applicable, PD = pharmacodynamics(s).
Note: Positive response to treatment was defined as reaching an absence of SA colonization, which was indicated by a semi-quantitative SA score of “Negative” or 0. P-values are from pairwise one-sided Fisher’s exact tests versus placebo.