This study will evaluate the safety and efficacy of VDPHL01 in male subjects with Androgenetic Alopecia (AGA). AGA (or male pattern baldness) is a genetic disorder caused by an excessive (too much) hair follicle response to androgens (hormone) that causes hair loss. VDPHL01 8.5 mg Tablet is an investigational oral drug to treat male pattern baldness. 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). The first 7 visits will be part of the placebo-controlled period. The next 3 visits will be part of the treatment extension phase. All subjects will receive active drug in the treatment extension phase.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
480
Site 36
Birmingham, Alabama, United States
Site 28
Phoenix, Arizona, United States
Site 30
Fort Smith, Arkansas, United States
Site 35
Rogers, Arkansas, United States
Site 07
Fountain Valley, California, United States
Site 02
Fremont, California, United States
Changes in non-vellus Target Area Hair Counts (TAHC)
Change 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
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Site 34
Sherman Oaks, California, United States
Site 21
Vista, California, United States
Site 05
Castle Rock, Colorado, United States
Site 24
Englewood, Colorado, United States
...and 34 more locations