Safety and Efficacy of VDPHL01 in Males and Females with AGA

Launched by VERADERMICS, INC. · Jul 25, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new oral 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 where men experience hair loss due to genetic factors and hormonal changes. The study will include males aged 18 to 60 who have mild to moderate AGA and are generally healthy. Participants will take VDPHL01 twice a day for six months and will have a total of seven visits to the study site to monitor their progress.

To be eligible, participants must be willing to keep their hair at a certain length and style for the duration of the study. They also need to agree to have a small tattoo placed on their scalp to help with study measurements. However, certain health conditions, recent treatments, and lifestyle factors could prevent someone from participating. This trial aims to gather important information about the potential benefits and safety of VDPHL01 in helping with hair loss in men.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subject is male or non-pregnant female 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 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;
• • Subject has symptoms or history of certain heart or thyroid conditions;
• • Subject has a history of cardiac and/or thyroid diseases;
• • Subject has received an organ transplant;
• • Subject has a history of prescription drug abuse or illicit drug use within 6 months of screening; history of alcohol abuse within 6 months prior to screening;
• • Subject has a current or recent history of dietary or weight changes;
• • Subject has been diagnosed with COVID-19 within 16 weeks of baseline;
• • Subject has used any topical scalp treatments for hair growth within 4 weeks prior to screening;
• • Subject has had any scalp procedures, including surgical, laser, light or energy treatments, micro-needling, etc. within 6 months prior to screening;
• • Subject has had previous radiation of the scalp;
• • Subject has used systemic cimetidine, ketoconazole, diazoxide, or corticosteroids (including intramuscular, intraarticular, and intralesional injections) within 12 weeks prior to screening;
• • Subject has used systemic beta blockers within 12 weeks prior to screening;
• • Subject is currently enrolled in an investigational drug, biologic, or device study or has used an investigational treatment within 30 days 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.