Safety and Efficacy of VDPHL01 in Males and Females with AGA

Phase

Condition

Male Pattern Baldness

Alopecia

Scalp Disorders

Treatment

VDPHL01

Clinical Study ID

NCT06527365

250-13951-207

Ages 18-65
All Genders

Study 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 (too much) hair follicle response to androgens (hormone) that causes hair loss. VDPHL01 8.5 mg Tablets for males and VDPHL01 4.5 mg Tablets for females are an investigational oral drug to treat male and female pattern baldness.

This multiple center, open-label, 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). Male subjects that meet the study eligibility criteria will be administered VDPHL01 once daily for 12 months. Female subjects that meet the study eligibility criteria will be administered VDPHL01 either once or twice daily for 12 months.

Eligibility Criteria

Inclusion

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 withthe same hairstyle, hair length, and hair color throughout the study; maintainconsistent 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 theprotocol.

Exclusion

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 monthsof 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 priorto screening;
Subject has had any scalp procedures, including surgical, laser, light or energytreatments, 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 12weeks 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 studyor has used an investigational treatment within 30 days prior to screening;
Subject has used any other therapy with any medication either topical or oral thatmight, in the investigator's opinion, interfere with the study.

Study Design