Recruiting NCT07146022

Safety and Efficacy of VDPHL01 in Females With Androgenetic Alopecia (AGA)

Phase III Interventional Androgenetic Alopecia (AGA) Androgenetic Alopecia AGA Female Androgenetic Alopecia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: VDPHL01 QD, Placebo, VDPHL01 BID, Placebo.
Who it may be relevant to: Registry conditions: Androgenetic Alopecia (AGA), Androgenetic Alopecia, AGA, Female Androgenetic Alopecia. Basic parameters: 18 years — 65 years · Female.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Detailed description

Not required.

Interventions

Drug VDPHL01 QD
VDPHL01 Extended Release (ER) Tablet
Drug Placebo
Placebo tablet
Drug VDPHL01 BID
VDPHL01 Extended Release (ER) Tablet
Drug Placebo
Placebo tablet

Primary outcome measures

Changes in non-vellus Target Area Hair Counts (TAHC) [Time frame: Month 6]
Subjects Evaluation of Treatment Benefit [Time frame: Month 6]

Eligibility criteria

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 English;
Subject is willing and able to swallow study drug whole;
Subject agrees to have a micro dot tattoo placed on their scalp;
Subject agrees to have this area photographed at study visits as indicated in the protocol.

Exclusion criteria

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;
Subject has been diagnosed with COVID-19 within 16 weeks of baseline;
Subject has had previous radiation of the scalp;
Use of any of the following treatments within the indicated washout period before screening:

Subject has used hormone replacement therapy or hormonal modulators within 6 months prior to screening
Subject has used oral treatments for hair growth or that can affect hair growth, including systemic retinoids, within 6 months of screening
Subject has used systemic calcium channel blockers or beta blockers within 12 weeks prior to screening
Subject has used systemic cimetidine, ketoconazole, diazoxide, or corticosteroids (including intramuscular, intraarticular, and intralesional injections) within 12 weeks prior to screening
Subject has had any scalp procedures, including surgical, laser, light or energy treatments, micro-needling, injections, platelet rich plasma within 6 months prior to screening
Subject has used any topical scalp treatments for hair growth within 12 weeks prior to screening
Subject has used any other therapy with any medication either topical or oral that might, in the investigator's opinion, interfere with the study;
Subject has any other condition that, in the investigator's opinion, interfere with the study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Quadruple blind
Primary purpose: Treatment

Study locations

United States · 71 centers

Site 73 — Birmingham
Site 89 — Birmingham
Site 77 — Phoenix
Site 30 — Fort Smith
Site 69 — Encino
Site 2 — Fremont
Site 64 — Manhattan Beach
Site 93 — Northridge
… and 63 more centers

Identifiers

NCT: NCT07146022 · 250-13951-306

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗