TABLE 2.
Primary and secondary outcomes at baseline and Days 7 and 14.
| Variable | Groups | p‐value | ||
|---|---|---|---|---|
| Atorvastatin nano‐emulgel 1% w/w | Atorvastatin emulgel 1% w/w | Placebo emulgel | ||
| Mean (SD) | ||||
| Redness | ||||
| Baseline | 2.44 (0.7) | 2.40 (0.6) | 2.29 (0.68) | 0.955 |
| Day 7 | 0.8 (0.4) | 1.0 (0.89) | 1.53 (0.51) | 0.003 * |
| Day 14 | 0.15 (0.06) | 0.2 (0.44) | 0.82 (0.52) | 0.001 * |
| Oedema | ||||
| Baseline | 1.63 (0.7) | 1.5 (0.63) | 1.76 (0.66) | 0.804 |
| Day 7 | 0.72 (0.66) | 0.56 (0.51) | 1.00 (0.50) | 0.001 * |
| Day 14 | 0.11 (0.32) | 0.19 (0.40) | 0.24 (0.43) | 0.630 |
| Ecchymosis | ||||
| Baseline | 2.2 (0.4) | 2.00 (0.3) | 2.10 (0.28) | 0.859 |
| Day 7 | 0.8 (0.24) | 0.95 (0.36) | 1.35 (0.06) | 0.001 * |
| Day 14 | 0.2 (0.08) | 0.31 (0.1) | 0.59 (0.15) | 0.001 * |
| Discharge | ||||
| Baseline | 0.78 (0.42) | 0.65 (0.15) | 0.67 (0.10) | 0.844 |
| Day 7 | 0.17 (0.06) | 0.15 (0.07) | 0.3 (0.06) | 0.001 * |
| Day 14 | 0.00 (0.0) | 0.00 (0.0) | 0.00 (0.0) | 1.000 |
| Approximation | ||||
| Baseline | 0.61 (0.11) | 0.55 (0.09) | 0.6 (0.1) | 0.754 |
| Day 7 | 0.25 (0.07) | 0.20 (0.20) | 0.30 (0.06) | 0.021 * |
| Day 14 | 0.08 (0.01) | 0.06 (0.02) | 0.1 (0.02) | 0.853 |
| REEDA | ||||
| Baseline | 1.48 (0.33) | 1.40 (0.30) | 1.41 (0.28) | 0.665 |
| Day 7 | 0.54 (0.19) | 0.60 (0.19) | 0.90 (0.12) | 0.022 * |
| Day 14 | 0.12 (0.04) | 0.15 (0.05) | 0.35 (0.06) | 0.019 * |
| VAS | ||||
| Baseline | 9.22 (0.8) | 9.00 (0.8) | 9.26 (0.77) | 0.551 |
| Day 1 | 6.72 (0.89) | 7.50 (1.3) | 7.06 (0.74) | 0.010 |
| Day 2 | 5.86 (0.9) | 6.38 (0.95) | 6.82 (0.88) | 0.015 |
| Day 7 | 3.56 (1.9) | 4.06 (1.43) | 5.35 (1.11) | 0.001 * |
| Day 14 | 2.22 (1.16) | 2.87 (1.54) | 3.7 (0.15) | 0.006 * |
*
Statistically significant (p‐value < 0.05); REEDA: Redness, Edema, Ecchymosis/bruising, Discharge, Approximation; VAS: visual analogue scale; w/w: weight/weight; SD: standard deviation.