TABLE 3.
Summary of efficacy outcomes (modified intention‐to‐treat population)
| Endpoint | 0.75% metronidazole gel (n = 65) | Vehicle (n = 65) | Difference (0.75% metronidazole gel vs vehicle) | |||
|---|---|---|---|---|---|---|
| n | n (%) [95% CI] e | n | n (%) [95% CI] e | % [95% CI] e | p | |
| Primary a | ||||||
| Proportion of patients who achieved a score of ≥3 for both percent change in inflammatory lesions and change in erythema severity at week 12 | 65 | 47 (72.3) [59.8–82.7] | 65 | 24 (36.9) [25.3–49.8] | 35.4 [17.9–51.3] | <0.0001 |
| Secondary a , b | ||||||
| Proportion of patients who achieved a score of ≥3 for percent change in the number of inflammatory lesions at week 12 | 65 | 52 (80.0) [68.2–88.9] | 65 | 29 (44.6) [32.3–57.5] | 35.4 [17.9–51.3] | <0.0001 |
| Proportion of patients who achieved score of ≥3 for change in erythema severity at week 12 | 65 | 51 (78.5) [66.5–87.7] | 65 | 37 (56.9) [44.0–69.2] | 21.5 [3.6–38.4] | 0.0086 |
| Proportion of patients who achieved an IGA score of 0 or ≤1 at week 12 | 65 | 25 (38.5) [26.7–51.4] | 65 | 12 (18.5) [9.9–30.0] | 20.0 [2.1–37.0] | 0.0115 |
| n | LS mean [95% CI] | n | LS mean [95% CI] | LS mean [95% CI] | p | |
|---|---|---|---|---|---|---|
| Change over time in percent change in the number of inflammatory lesions (week 12) | 65 | ‒76.4 [‒90.5 to ‒62.4] | 65 | ‒27.5 [‒41.7 to ‒13.3] | ‒48.9 [‒68.9 to ‒28.9] | <0.0001 |
| Change over time in erythema severity (week 12) | 65 | 1.6 [1.4–1.8] | 65 | 2.2 [1.9–2.4] | ‒0.6 [‒0.9 to ‒0.3] | 0.0004 |
| n | n (%) [95% CI] e | n | n (%) [95% CI] e | % [95% CI] e | p | |
|---|---|---|---|---|---|---|
| Other | ||||||
| Proportion of patients with an improvement of ≥4 points in the DLQI total score at week 12 c | 23 | 16 (69.6) [47.1–86.8] | 28 | 18 (64.3) [44.1–81.4] | 5.3 [‒22.1 to 32.1] | 0.6906 |
| Proportion of patients with an improvement of ≥10 points in the Skindex‐16 overall score at week 12 d | 52 | 43 (82.7) [69.7–91.8] | 58 | 32 (55.2) [41.5–68.3] | 27.5 [9.0–44.8] | 0.0020 |
p‐values for binary variables were calculated using the Pearson χ2‐test. p‐values for continuous variables were calculated using the mixed model for repeated measure.
Abbreviations: CI, confidence interval; DLQI, dermatology life quality index; IGA, Investigator’s Global Assessment; LS, least squares.
a
For binary variables, missing values were imputed as non‐responders; no imputations were made for continuous variables.
b
Analyses of secondary endpoints were not adjusted for multiplicity.
c
Among patients with a DLQI score of ≥4 at baseline.
d
Among patients with a Skindex‐16 score of ≥10 at baseline.
e
Exact 95% CI are shown.