Safety and Efficacy of VDPHL01 in Females With Androgenetic Alopecia (AGA)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorVeradermics, Inc.
About this trial
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).
Eligibility criteria
Qualifiers
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;
Disqualifiers
Subject has uncontrolled blood pressure or orthostatic hypotension;
Subject has symptoms or history of certain heart or thyroid conditions;
Subject has a history of or active hair loss due to conditions/diseases other than AGA;
Subject has a current or recent history of dietary or weight changes, including use of GLP-1 agonists;
Trial design
Treatments tested in this trial
- VDPHL01 QD
- Placebo
- VDPHL01 BID
- Placebo
Treatment groups
552 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov