Table 2.
Pain score | Visit 1 | Visit 2 | Visit 3 | Change from visit 1 to 2 | Change from visit 2 to 3 | Change from visit 1 to 3 |
---|---|---|---|---|---|---|
Phase one (n = 27) | ||||||
Control keloids | ||||||
Mean ± SD | 1.2 ± 2.0 | 1.0 ± 1.8 | 1.0 ± 1.9 | − 0.2 ± 1.0 | − 0.04 ± 0.8 | − 0.2 ± 1.3 |
Median (min, max) | 0.0 (0.0, 6.0) | 0.0 (0.0, 5.0) | 0.0 (0.0, 7.0) | 0.0 (− 5.0, 1.0) | 0.0 (− 2.0, 3.0) | 0.0 (− 5.0, 3.0) |
p value for comparing visits within the control group | 0.344 | 0.796 | 0.256 | |||
Microneedle-treated keloids | ||||||
Mean ± SD | 0.9 ± 1.5 | 0.3 ± 0.8 | 0.4 ± 1.1 | − 0.5 ± 1.1 | − 0.1 ± 0.9 | − 0.4 ± 1.1 |
Median (min, max) | 0.0 (0.0, 5.0) | 0.0 (0.0, 3.0) | 0.0 (0.0, 4.0) | 0.0 (− 4.0, 0.0) | 0.0 (− 2.0, 4.0) | 0.0 (− 4.0, 1.0) |
p value for comparing visits within the microneedle group | 0.007 | 0.509 | 0.035 | |||
Phase two (n = 17) | ||||||
Control keloids | ||||||
Mean ± SD | 0.6 ± 1.8 | 0.7 ± 1.8 | 0.4 ± 1.2 | 0.1 ± 0.5 | − 0.3 ± 0.8 | − 0.2 ± 0.7 |
Median (min, max) | 0.0 (0.0, 7.0) | 0.0 (0.0, 7.0) | 0.0 (0.0, 4.0) | 0.0 (0.0, 2.0) | 0.0 (− 3.0, 0.0) | 0.0 (− 3.0, 0.0) |
p value for comparing visits within the control group | 0.477 | 0.141 | 0.286 | |||
Microneedle-treated keloids | ||||||
Mean ± SD | 0.4 ± 1.7 | 0.1 ± 0.5 | 0.5 ± 1.9 | − 0.3 ± 1.2 | 0.4 ± 1.5 | 0.1 ± 0.2 |
Median (min, max) | 0.0 (0.0, 7.0) | 0.0 (0.0, 2.0) | 0.0 (0.0, 8.0) | 0.0 (− 5.0, 0.0) | 0.0 (0.0, 6.0) | 0.0 (0.0, 1.0) |
p value for comparing visits within the microneedle group | 0.187 | 0.157 | 0.792 | |||
p value for comparing visits between control and microneedle groups | ||||||
Phase one control versus phase one microneedle group | 0.230 | 0.551 | 0.551 | |||
Phase two control versus phase two microneedle group | 0.058 | 0.025 | 0.161 | |||
p value for comparing microneedle groups between phase one and phase two | ||||||
Phase one microneedle versus phase two microneedle group | 0.515 | 0.105 | 0.055 |
Significance level of p ≤ 0.05 are shown in underline