A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Dose Study to Evaluate the Efficacy and Safety of VDPHL01 in Female Subjects With Androgenetic Alopecia
Veradermics, Inc.
Summary
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).
Description
Not required.
Eligibility
- Age range
- 18–65 years
- Sex
- Female
- Healthy volunteers
- No
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 hairstyle, hair length, and hair color throughout the study; maintain consistent use of general hair care products and regimen through the entire study; * Subject is willing and able to administer the test article as directed and can read, understand, and complete the required questionnaires in Engl…
Interventions
- DrugVDPHL01 QD
VDPHL01 Extended Release (ER) Tablet
- DrugPlacebo
Placebo tablet
- DrugVDPHL01 BID
VDPHL01 Extended Release (ER) Tablet
- DrugPlacebo
Placebo tablet
Locations (71)
- Site 73Birmingham, Alabama
- Site 89Birmingham, Alabama
- Site 77Phoenix, Arizona
- Site 30Fort Smith, Arkansas
- Site 69Encino, California
- Site 2Fremont, California