TABLE 1.
Summary of studies included in pooled analysis of bimatoprost 0.03% for eyelash hypotrichosis treatment
| STUDY NUMBER* AND ETIOLOGY | SUBJECTS ENROLLED IN EACH GROUP, N | STUDY TREATMENT DURATION† MONTHS | STUDY DESIGN | STUDY POPULATION | MEAN AGE, YEARS (RANGE) | ||
|---|---|---|---|---|---|---|---|
| BIM 0.03% | VEH | ||||||
| Study 111 | |||||||
|
NCT00693420 Idiopathic Postchemotherapy |
137 - |
141 - |
4 | Phase 3 R, DM, PG | General (US, Canada) | 49.8 (22-78) | |
| Study 212 NCT01391273 Idiopathic Postchemotherapy |
87 - |
85 - |
4 | Phase 3 R, DM, PG | Japanese (Japan) | 40.8 (20-68) | |
| Study 312 NCT01391286 Idiopathic Postchemotherapy |
- 18 |
- 18 |
4 | Phase 3 R, DM, PG | Japanese (Japan) | 50.6 (31-74) | |
| Study 4 NCT00958035 Idiopathic Postchemotherapy |
46 - |
43 - |
4 | Phase 4 R, DM, PG | African American (US) | 46.5 (19-75) | |
| Study 5 NCT01064882 Idiopathic Postchemotherapy |
34 - |
- - |
3 | Phase 2 R, DM, AC, PG | Caucasian (US) | 46.3 (31-55) | |
| BIM/BIM | BIM/VEH | VEH/BIM | STUDY treatment duration† MONTHS | STUDY DESIGN | STUDY POPULATION | MEAN AGE, YEARS (RANGE) | |
| Study 6[14] NCT00907426 Idiopathic Postchemotherapy |
118 96 |
60 - |
59 33 |
12‡ | Phase 3 R, DM, PG | General (US, Europe) | 49.8 (20-76) |
Both the study number and ClinicalTrials.gov registration number (available at www.clinicaltrials.gov) are provided.
Time of active study treatment (does not include post-treatment periods).
Study 6 was a 12-month study comprising two six-month treatment periods. For the first six months, subjects were randomized to treatment with either bimatoprost 0.03% or vehicle (treatment period 1). From Month 6 to Month 12 (treatment period 2), all subjects who received vehicle during treatment period 1 were switched to bimatoprost, whereas subjects who received bimatoprost during treatment period 1 were randomized to either continue receiving bimatoprost or switch to vehicle.
AC=active controlled; BIM=bimatoprost; DM=double masked; PG=parallel group; R=randomized; US=United States; VEH=vehicle