This study will evaluate the safety and efficacy of VDPHL01 in female subjects with Androgenetic Alopecia (AGA). AGA is a genetic disorder caused by an excessive (too much) hair follicle response to androgens (hormones) that causes hair loss. VDPHL01 is an investigational oral drug to treat AGA. This multi-center, double blind, study will last about 13 months and includes 11 study visits (screening, baseline (day 1), week 2, month 1, month 2, month 4, month 6, month 8, month 10, month 12, month 13).
Not required.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
552
VDPHL01 Extended Release (ER) Tablet
Placebo tablet
VDPHL01 Extended Release (ER) Tablet
Placebo tablet
Site 73
Birmingham, Alabama, United States
Site 89
Birmingham, Alabama, United States
Site 77
Phoenix, Arizona, United States
Site 30
Fort Smith, Arkansas, United States
Site 69
Encino, California, United States
Site 2
Fremont, California, United States
Changes in non-vellus Target Area Hair Counts (TAHC)
Changes from baseline in non-vellus TAHC using digital image analysis at Month 6.
Time frame: Month 6
Subjects Evaluation of Treatment Benefit
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.
Time frame: Month 6
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Site 64
Manhattan Beach, California, United States
Site 93
Northridge, California, United States
Site 66
Santa Monica, California, United States
Site 34
Sherman Oaks, California, United States
...and 61 more locations