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Tests treatment safety and results for Androgenetic Alopecia (AGA)
Official title Safety and Efficacy of VDPHL01 in Females With Androgenetic Alopecia (AGA)
ClinicalTrials.gov ID: NCT07146022
What this study is testing
What is VDPHL01 QD?
VDPHL01 QD is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for androgenetic alopecia (aga).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65, women only
You may be able to join if
- 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...
- Subject is willing and able to administer the test article as directed and can read, understand, and complete the required questionnaires in English;
You likely can't join if
- 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;
See the full eligibility 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...
- 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- Fort Smith, Arkansas, United States
- Encino, California, United States
- Fremont, California, United States
- Manhattan Beach, California, United States
- Northridge, California, United States
- Santa Monica, California, United States
- Sherman Oaks, California, United States
- Thousand Oaks, California, United States
- Vista, California, United States
- Castle Rock, Colorado, United States
- Greenwood Village, Colorado, United States
- Aventura, Florida, United States
- Boca Raton, Florida, United States
- Coral Gables, Florida, United States
- Miami, Florida, United States
- Ocala, Florida, United States
- Atlanta, Georgia, United States
- Sandy Springs, Georgia, United States
+ 48 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Phoenix, Arizona, United States; Fort Smith, Arkansas, United States; Encino, California, United States; Fremont, California, United States; Manhattan Beach, California, United States and 62 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.