Clinical trial NCT06527365: Safety and Efficacy of VDPHL01 in Males and Females with AGA
Official title: An Open-Label Multi-Dose Study to Evaluate the Safety and Efficacy of VDPHL01 in Male and Female Subjects with Androgenetic Alopecia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Androgenetic Alopecia
AGA
Male Pattern Baldness
Keywords: Hair Loss
Male Hair Loss
Female Hair Loss
Lead sponsor: Veradermics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-07-30
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Males will not be randomized. Females will be assigned once a day or twice a day treatment in an alternating fashion at each site.
Primary purpose: TREATMENT

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 (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 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.

Primary outcomes:
measure: Changes in non-vellus Total Area Hair Count (TAHC)
timeFrame: Month 12
measure: Subjects Evaluation of Treatment Benefit
timeFrame: Month 12
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: 01
state: California
city: New Albany
country: United States
facility: 04
state: Indiana
city: Hackensack
country: United States
facility: 03
state: New Jersey
city: South Jordan
country: United States
facility: 02
state: Utah
Study officials:
affiliation: Veradermics, Inc.
name: Reid Waldman, M.D.
role: STUDY_CHAIR
affiliation: Veradermics, Inc.
name: Timothy Durso, M.D.
role: STUDY_DIRECTOR
References: