Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
VDPHL01 · 4 trials · 6 indications
Changes from baseline in non-vellus TAHC using digital image analysis at Month 6.
Subjects will rate their treatment benefit by responding to a hair assessment scale. The proportion of subjects by each response category will be reported at Month 6.
Change from baseline in non-vellus TAHC using digital image analysis at Month 12.
| Arm | Type | Description |
|---|---|---|
| VDPHL01 BID | EXPERIMENTAL | VDPHL01 will be taken orally twice a day (BID), once in the AM and once in the PM for the first 6 months of the study. After month 6, subject will continue VDPHL01 BID for an additional 6 months. |
| VDPHL01 QD and Placebo QD | EXPERIMENTAL | Placebo will be taken orally once a day (QD) in the AM or PM. VDPHL01 will be taken orally once a day (QD) in the AM or PM for the first 6 months of the study. After month 6, subject will continue this same dose regimen for an additional 6 months. |
| Placebo BID with treatment extension to VDPHL01 BID | PLACEBO_COMPARATOR | Placebo will be taken orally twice a day (BID), once in the AM and once in the PM for the first 6 months of the study. After month 6, subject will switch to VDPHL01 BID group, and take VDPHL01 orally twice a day (BID), once in the AM and once in the PM for an additional 6 months. |
| Placebo BID with treatment extension to VDPHL01 QD and Placebo QD | PLACEBO_COMPARATOR | Placebo will be taken orally twice a day (BID), once in the AM and once in the PM for the first 6 months of the study. After month 6, subject will switch to VDPHL01 QD and Placebo QD group, and take placebo orally once a day in the AM or PM; VDPHL01 will be taken orally once a day in the AM or PM for an additional 6 months. |
| VDHPL01 BID | EXPERIMENTAL | VDPHL01 will be taken orally twice a day, once in the AM and once in the PM. |
| VDPHL01 Tablet | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| VDPHL01 QD | DRUG | VDPHL01 Extended Release (ER) Tablet |
| Placebo | DRUG | Placebo tablet |
| VDPHL01 BID | DRUG | VDPHL01 Extended Release (ER) Tablet |
| VDPHL01 | DRUG | VDPHL01 Extended Release (ER) Tablet |
Inclusion Criteria: * Subject is a female aged 18-65 years old; * Subject has a clinical diagnosis of mild to moderate AGA; * Subject is in good general health and has adequate renal and hepatic function; * Subject is willing to maintain at least 1/4 inch length hair during the study with the same ...