Status:
ACTIVE_NOT_RECRUITING
Safety and Efficacy of VDPHL01 in Males and Females With AGA
Lead Sponsor:
Veradermics, Inc.
Conditions:
Androgenetic Alopecia
AGA
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This study will evaluate the safety and efficacy of VDPHL01 in male and female subjects with Androgenetic Alopecia (AGA). AGA (or pattern of hair loss) is a genetic disorder caused by an excessive (t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06527365
Start Date
July 8 2024
End Date
August 1 2026
Last Update
November 6 2025
Active Locations (4)
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1
01
San Diego, California, United States, 92123
2
04
New Albany, Indiana, United States, 47150
3
03
Hackensack, New Jersey, United States, 07601
4
02
South Jordan, Utah, United States, 84095