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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
VDPHL01 QD
DrugVDPHL01 Extended Release (ER) Tablet
Placebo
DrugPlacebo tablet
VDPHL01 BID
DrugVDPHL01 Extended Release (ER) Tablet
Placebo
DrugPlacebo tablet
Treatment groups
552 Participants
are divided into 4 treatment groupsGroup A: VDPHL01 BIDExperimental treatment 1 intervention
Group B: VDPHL01 QD and Placebo QDExperimental treatment 2 interventions
Group C: Placebo BID with treatment extension to VDPHL01 BIDPlacebo comparator 1 intervention
Group D: Placebo BID with treatment extension to VDPHL01 QD and Placebo QDPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 62
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 6Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov