TABLE 2.
Changes from the baseline in hair count and diameter at weeks 8 and 16
| ITT | Observed value | Change from baseline | ||||
|---|---|---|---|---|---|---|
| Vehicle (n = 19) | ADSC‐CE (n = 19) | P value | Vehicle (n = 19) | ADSC‐CE (n = 19) | P value | |
| Hair counts, number | ||||||
| Week 0 | 17.58 ± 4.13 | 13.95 ± 4.01 | .009 a | — | — | — |
| Week 8 | 17.05 ± 4.85 | 15.95 ± 4.78 | .011 b | −0.53 ± 2.39 | 2.00 ± 2.79 | .005 a |
| Week 16 | 18.79 ± 4.92 | 17.63 ± 5.41 | .003 b | 1.21 ± 1.87 | 3.68 ± 3.06 | .014 c |
| Hair diameter, mm | ||||||
| Week 0 | 0.055 ± 0.006 | 0.057 ± 0.006 | .508 c | — | — | — |
| Week 8 | 0.059 ± 0.007 | 0.063 ± 0.008 | .140 c | 0.004 ± 0.005 | 0.006 ± 0.007 | .569 c |
| Week 16 | 0.059 ± 0.006 | 0.065 ± 0.009 | .058 c | 0.003 ± 0.004 | 0.008 ± 0.007 | .014 a |
| PP | Observed value | Change from baseline | ||||
|---|---|---|---|---|---|---|
| Vehicle (n = 16) | ADSC‐CE (n = 18) | P value | Vehicle (n = 16) | ADSC‐CE (n = 18) | P value | |
| Hair counts, number | ||||||
| Week 0 | 17.81 ± 4.32 | 13.89 ± 4.11 | .011 a | — | — | — |
| Week 8 | 17.19 ± 5.17 | 16.00 ± 4.91 | .014 b | −0.63 ± 2.60 | 2.11 ± 2.83 | .006 a |
| Week 16 | 19.25 ± 5.12 | 17.78 ± 5.53 | .006 b | 1.44 ± 1.97 | 3.89 ± 3.01 | .025 c |
| Hair diameter, mm | ||||||
| Week 0 | 0.055 ± 0.005 | 0.057 ± 0.006 | .332 c | — | — | — |
| Week 8 | 0.059 ± 0.007 | 0.064 ± 0.008 | .073 c | 0.004 ± 0.006 | 0.007 ± 0.008 | .863 c |
| Week 16 | 0.059 ± 0.005 | 0.066 ± 0.009 | .021 c | 0.004 ± 0.004 | 0.008 ± 0.007 | .023 a |
Notes. Values are expressed as mean ± SD. Shapiro‐Wilk's test was used to test for normality.
Abbreviations: —, no data; ADSC‐CE, adipose‐derived stem cell constituent extract; ITT, intention‐to‐treat; PP, per protocol.
a
P values according to independent t test.
b
P values were adjusted for the observed value at baseline by using the baseline values as covariates in analysis of covariance.
c
P values according to Mann‐Whitney U test.