Safety and Efficacy of VDPHL01 in Males and Females With AGA

NCT06527365 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: 250-13951-207
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 4

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.

Conditions

Androgenetic Alopecia; AGA; Male Pattern Baldness

Keywords

Hair Loss; Male Hair Loss; Female Hair Loss

Outcome Measures

Primary Outcomes (2)

• Changes in non-vellus Total Area Hair Count (TAHC)

  Change from baseline in non-vellus TAHC using digital image analysis at Month 12.

  Month 12

• Subjects Evaluation of Treatment Benefit

  Subjects will rate their treatment benefit by responding to a hair assessment scale. The proportion of subjects by each response category will be reported at Month 12.

  Month 12

Study Arms (1)

VDPHL01 Tablet

EXPERIMENTAL

Drug: VDPHL01

Interventions

VDPHL01 DRUG

VDPHL01 Extended Release (ER) Tablet

VDPHL01 Tablet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Veradermics, Inc.: lead

Study Sites (4)

01

San Diego, California, 92123, United States

Location

04

New Albany, Indiana, 47150, United States

Location

03

Hackensack, New Jersey, 07601, United States

Location

02

South Jordan, Utah, 84095, United States

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Reid Waldman, M.D.

  Veradermics, Inc.

  STUDY CHAIR

• Timothy Durso, M.D.

  Veradermics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Males will not be randomized. Females will be assigned once a day or twice a day treatment in an alternating fashion at each site.

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: July 30, 2024
• Study Start: July 8, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: November 6, 2025

Record last verified: 2025-11

Locations

US (4)