Table 2.
Summary of Efficacy: Mean Changes in Hair. This table shows statistically significant efficacy in primary outcomes of the ALRV5XR group measured by increases in absolute and per cent Terminal Hair at week 24. Secondary outcomes all show statistically significant changes in favour of the ALRV5XR group at 24 weeks and in absolute and per cent Terminal Hair at week 12. The effect size shows highly favourable odds ratios in favour of ALRV5XR at 12 weeks, with multi-fold increases from 12 to 24 weeks.
| Placebo |
ALRV5XR |
Efficacy |
Effect size | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| N | Mean | SD | Min | Max | N | Mean | SD | Min | Max | ∆-Mean | (95% CI) | p-value | Odds Ratio | |
| Terminal hairs/cm2 | ||||||||||||||
| Week 0–12 | 10 | −2·9 | ± 8·0 | −17 | 9 | 11 | 8·0 | ± 8·4 | −3 | 25 | 10·9 | 3·4 – 18·4 | 0·0065 | 10·0 |
| Week 0–24 (Primary) | 11 | −5·8 | ± 5·5 | −12 | 3 | 11 | 15·2 | ± 18·0 | 0 | 51 | 21·0 | 9·2 – 32·8 | 0·0014 | 87·4 |
| Terminal Hairs (%) | ||||||||||||||
| Week 0–12 | 10 | −2·5% | ± 6·0% | −12·1% | 7·0% | 11 | 6·7% | ± 8·2% | −3·4% | 22·9% | 9·3% | 2·7 – 15·9% | 0·0084 | 10·0 |
| Week 0–24 (Primary) | 11 | −4·5% | ± 4·1% | −12·3% | 1·6% | 11 | 11·9% | ± 13·8% | 0 | 46·8% | 16·4% | 7·4 – 25·5% | 0·0012 | 87·4 |
| Vellus Hairs/cm2 | ||||||||||||||
| Week 0–12 | 8 | −0·3 | ± 7·8 | −12 | −8 | 10 | −2·8 | ± 9·6 | −19 | 17 | −2·6 | −11·4 – 6·3 | 0·5511 | 0·2 |
| Week 0–24 | 10 | 4·8 | ± 6·9 | −8 | 15 | 10 | −5·7 | ± 11·0 | −24 | 12 | −10·5 | −19·1 – 1·9 | 0·0196 | 0·1 |
| Vellus Hairs (%) | ||||||||||||||
| Week 0–12 | 8 | −0·3% | ± 7·2% | −10·1% | 11·1% | 10 | −1·7% | ± 10·1% | −11·1% | 23·9% | −2·1% | −11·2 – 7·0% | 0·6314 | 0·2 |
| Week 0–24 | 10 | −4·9% | ±7·5% | −6·7% | 20·5% | 10 | −7·1% | ± 12·2% | −23·6% | 9·9% | −12·0% | −21·5 – 2·5% | 0·0158 | 0·1 |
| Terminal to Vellus Ratio | ||||||||||||||
| Week 0–12 | 8 | −0·0 | ± 0·2 | 0·3 | 0·2 | 10 | 0·1 | ± 0·4 | −0·8 | 0·65 | 0·1 | −0·2 – 0·4 | 0·3955 | 6·7 |
| Week 0–24 | 10 | 0·2 | ± 0·2 | 0·5 | 0·1 | 10 | 0·4 | ± 0·6 | −0·0 | 1·8 | 0·5 | 0·1 – 0·9 | 0·0097 | 81·0 |
| Terminal to Vellus Ratio (%) | ||||||||||||||
| Week 0–12 | 8 | −2·5% | ± 13·3% | −19·2% | 19·0% | 10 | 10·3% | ± 15·0% | −16·9% | 32·6% | 12·8% | −1·6 – 27·2% | 0·0769 | 6·7 |
| Week 0–24 | 10 | −8·6% | ± 9·0% | −23·6% | 8·9% | 10 | 24·4% | ± 29·4% | −1·3% | 92·2% | 33·0% | 12·5 – 53·4% | 0·0033 | 81·0 |
Abbreviations: Primary = Primary Outcomes; Week = Baseline; N = Per Protocol evaluable population paired with baseline; SD = standard deviation; Mean = Mean of Differences between Week 12 or 24 and Baseline; ∆-Mean = Difference of Means between ALRV5XR and Placebo.