Table 2.
Efficacy end point | Time point | Idiopathic hypotrichosis bimatoprost (n = 179) treatment responders | Idiopathic hypotrichosis vehicle (n = 59) treatment responders | P‐value |
---|---|---|---|---|
Composite end point: ≥ 1‐grade increase in GEA score and ≥ 3‐point improvement in ESQ Domain 2 | Month 4a | 72 (40·2) | 4 (6·8) | < 0·01 |
Month 6 | 85 (47·5) | 2 (3·4) | < 0·01 | |
≥ 1‐grade increase in GEA | Month 4 | 133 (74·3) | 8 (13·6) | < 0·01 |
Month 6 | 139 (77·7) | 8 (13·6) | < 0·01 | |
≥ 3‐point increase in ESQ Domain 2 | Month 4 | 85 (47·5) | 9 (15·3) | < 0·01 |
Month 6 | 100 (55·9) | 9 (15·3) | < 0·01 | |
≥ 2‐grade increase in GEA Score | Month 4 | 46 (25·7) | 0 (0·0) | < 0·01 |
Month 6 | 55 (30·7) | 0 (0·0) | < 0·01 |
Efficacy end pointa | Time point | Chemotherapy‐induced hypotrichosis patients receiving bimatoprost (n = 96) treatment responders | Chemotherapy‐induced hypotrichosis patients receiving vehicle (n = 34) treatment responders | P‐valueb |
---|---|---|---|---|
Composite end point: ≥ 1‐grade increase in GEA score and ≥ 3‐point improvement in ESQ Domain 2 | Month 4a | 36 (37·5) | 6 (18·2)c | 0·04 |
Month 6 | 45 (46·9) | 6 (18·2)c | < 0·01 | |
≥ 1‐grade increase in GEA | Month 4 | 70 (72·9) | 18 (54·5)c | 0·05 |
Month 6 | 77 (80·2) | 17 (51·5)c | < 0·01 | |
≥ 3‐point increase in ESQ Domain 2 | Month 4 | 39 (40·6) | 8 (24·2)c | 0·09 |
Month 6 | 46 (47·9) | 12 (36·4)c | 0·25 | |
≥ 2‐grade increase in GEA score | Month 4 | 35 (36·5) | 2 (6·1)c | < 0·01 |
Month 6 | 44 (45·8) | 3 (9·1)c | < 0·01 |
Values are given as n (%). Bimatoprost, bimatoprost ophthalmic solution 0·03%. aMonth 4 is the primary analysis time point. bA Pearson's χ2 test was performed; if ≥ 25% of the cells had expected counts < 5, then Fisher's exact test was used instead. cOverall population of patients with chemotherapy‐induced hypotrichosis receiving vehicle was 33.