Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01231607 | Dutasteride Versus Placebo and Finasteride in Men With Androgenetic Alopecia | PHASE3 | COMPLETED | 917 | — | — | Oct 28, 2010 | Feb 28, 2012 | Aug 10, 2018 | 39 | Argentina, Chile +7 |
The primary target area HC was based on the nonvellus hair (\>=30 micrometers \[μm\] in width; thick and noticeable hair) count within a target 2.54 cm (1 inch) diameter circle at the vertex (crown, topmost part of the head). A cosmetic ink dot was placed by tattoo at BL so that the same area could be identified at BL and post-BL. If the ink dot faded, it was re-done in exactly the same location to ensure visibility for subsequent photographs. For the MT, hair was clipped before each photograph; HC was based on hair follicles in the photographs. Change from BL=Week 24 value minus the BL value.
| Arm | Type | Description |
|---|---|---|
| 1mg Finasteride | ACTIVE_COMPARATOR | 1mg finasteride active plus dutasteride placebo, by mouth once daily |
| 0.02mg Dutasteride | ACTIVE_COMPARATOR | 0.02mg dutasteride active plus finasteride placebo, by mouth once daily |
| 0.1mg Dutasteride | ACTIVE_COMPARATOR | 0.1mg dutasteride active plus finasteride placebo, by mouth once daily |
| 0.5mg Dutasteride | ACTIVE_COMPARATOR | 0.5mg dutasteride active plus finasteride placebo, by mouth once daily |
| Placebo | PLACEBO_COMPARATOR | 1mg finasteride placebo plus dutasteride placebo, by mouth once daily |
| Name | Type | Description |
|---|---|---|
| 1mg Finasteride active | DRUG | 1mg finasteride active, by mouth once daily |
| 0.02mg dutasteride | DRUG | 0.02mg dutasteride active, by mouth once daily |
| 0.1mg dutasteride | DRUG | 0.1mg dutasteride active, by mouth once daily |
| 0.5mg dutasteride | DRUG | 0.5mg dutasteride active, by mouth once daily |
| Finasteride placebo | DRUG | finasteride placebo, by mouth once daily |
| Dutasteride placebo | DRUG | dutasteride placebo, by mouth once daily |
Inclusion Criteria: * Norwood-Hamilton Type III vertex, IV, or V Exclusion Criteria: * History or evidence of hair loss other than androgenetic alopecia * Scarring of the scalp * Use of dutasteride in previous 18 months * Use of finasteride within previous 12 months * Hair transplantation or hair...