Efficacy and Safety of VDPHL01 in Males With AGA

Launched by VERADERMICS, INC. · Dec 4, 2024

Keywords

ClinConnect Summary

This clinical trial is testing a new medication called VDPHL01 to see how safe and effective it is for treating male pattern baldness, also known as Androgenetic Alopecia (AGA). AGA is a common condition in men that causes hair loss due to genetic factors and hormonal changes. The study will involve men aged 18 to 65 who have been diagnosed with mild to moderate AGA. Participants will need to keep their hair at least 1/4 inch long and maintain the same hairstyle and color throughout the study, which will last about 13 months and include 11 visits to the clinic.

During the first part of the study, some participants will receive VDPHL01, while others will receive a placebo (a pill with no active medication) to compare results. After this initial phase, everyone will receive the active medication. Participants will need to agree to have a small tattoo placed on their scalp to help with the study and will have photos taken at different visits. It's important for potential participants to be in good health and not have certain medical conditions, such as uncontrolled blood pressure or recent heart problems. Overall, this trial aims to find new ways to help men experiencing hair loss due to AGA.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Subject is male aged 18-65 years old;
• • Subject has a clinical diagnosis of mild to moderate AGA;
• • Subject is in good general health and has normal 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 read, understand, and complete 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 screening;
• • 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