ACTIVE_NOT_RECRUITING

Safety and Efficacy of VDPHL01 in Males and Females With AGA

Conditions

Androgenetic Alopecia AGA Male Pattern Baldness Hair Loss Male Hair Loss Female Hair Loss

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

An Open-Label Multi-Dose Study to Evaluate the Safety and Efficacy of VDPHL01 in Male and Female Subjects With Androgenetic Alopecia

Quick Facts

Study Start:2024-07-08

Study Completion:2026-08-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06527365

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Principal Investigator

Reid Waldman, M.D.

STUDY_CHAIR

Veradermics, Inc.

Timothy Durso, M.D.

STUDY_DIRECTOR

Veradermics, Inc.

Study Locations (Sites)

San Diego, California, 92123

United States

New Albany, Indiana, 47150

United States

Hackensack, New Jersey, 07601

United States

South Jordan, Utah, 84095

United States

Collaborators and Investigators

Sponsor: Veradermics, Inc.

Reid Waldman, M.D., STUDY_CHAIR, Veradermics, Inc.
Timothy Durso, M.D., STUDY_DIRECTOR, Veradermics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-08

Study Completion Date2026-08-28

Study Record Updates

Study Start Date2024-07-08

Study Completion Date2026-08-28

Terms related to this study

Keywords Provided by Researchers

Hair Loss
Male Hair Loss
Female Hair Loss

Additional Relevant MeSH Terms

Androgenetic Alopecia
AGA
Male Pattern Baldness