RECRUITING

Safety and Efficacy of VDPHL01 in Males With AGA

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 subjects with Androgenetic Alopecia (AGA). AGA (or male pattern baldness) is a genetic disorder caused by an excessive (too much) hair follicle response to androgens (hormone) that causes hair loss. VDPHL01 8.5 mg Tablet is an investigational oral drug to treat male pattern baldness. This multi-center, double blind, 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).

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-dose Study to Evaluate the Efficacy and Safety of VDPHL01 in Male Subjects With Androgenetic Alopecia

Quick Facts

Study Start:2025-03-11
Study Completion:2026-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06972264

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:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subject is male aged 18-65 years old;
  2. * Subject has a clinical diagnosis of mild to moderate AGA;
  3. * Subject is in good general health and has adequate renal and hepatic function;
  4. * 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;
  5. * Subject is willing and able to administer the test article as directed read, understand, and complete required questionnaires in English;
  6. * Subject is willing and able to swallow study drug whole;
  7. * Subject agrees to have a micro dot tattoo placed on their scalp;
  8. * Subject agrees to have this area photographed at study visits as indicated in the protocol.
  1. * Subject has uncontrolled blood pressure or orthostatic hypotension;
  2. * Subject has symptoms or history of certain heart or thyroid conditions;
  3. * Subject has a history of or active hair loss due to conditions/diseases other than AGA;
  4. * Subject has a current or recent history of dietary or weight changes, including use of GLP-1 agonists;
  5. * Subject has been diagnosed with COVID-19 within 16 weeks of screening;
  6. * Subject has had previous radiation of the scalp;
  7. * Use of any of the following treatments within the indicated washout period before screening:
  8. * Subject has used hormone replacement therapy or hormonal modulators within 6 months prior to screening
  9. * Subject has used oral treatments for hair growth or that can affect hair growth, including systemic retinoids, within 6 months of screening
  10. * Subject has used systemic calcium channel blockers or beta blockers within 12 weeks prior to screening
  11. * Subject has used systemic cimetidine, ketoconazole, diazoxide, or corticosteroids (including intramuscular, intraarticular, and intralesional injections) within 12 weeks prior to screening
  12. * Subject has had any scalp procedures, including surgical, laser, light or energy treatments, micro-needling, injections, platelet rich plasma within 6 months prior to screening
  13. * Subject has used any topical scalp treatments for hair growth within 12 weeks prior to screening
  14. * Subject has used any other therapy with any medication either topical or oral that might, in the investigator's opinion, interfere with the study;
  15. * Subject has any other condition that, in the investigator's opinion, interfere with the study

Contacts and Locations

Study Contact

Kate Mateja, MBA
CONTACT
858-571-1800
clinicalresearch@therapeuticsinc.com

Principal Investigator

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

Study Locations (Sites)

Site 73
Birmingham, Alabama, 35209
United States
Site 69
Encino, California, 91436
United States
Site 64
Manhattan Beach, California, 90266
United States
Site 66
Santa Monica, California, 90404
United States
Site 71
Boca Raton, Florida, 33486
United States
Site 86
Coral Gables, Florida, 33134
United States
Site 62
Coral Gables, Florida, 33146
United States
Site 61
Chicago, Illinois, 60611
United States
Site 53
Clarksville, Indiana, 47129
United States
Site 55
Plainfield, Indiana, 46168
United States
Site 52
Louisville, Kentucky, 40241
United States
Site 75
New Orleans, Louisiana, 70124
United States
Site 87
Rockville, Maryland, 20850
United States
Site 80
Chestnut Hill, Massachusetts, 02467
United States
Site 59
Quincy, Massachusetts, 02169
United States
Site 68
Clinton Township, Michigan, 48038
United States
Site 83
Troy, Michigan, 48084
United States
Site 72
Cincinnati, Ohio, 45236
United States
Site 57
Portland, Oregon, 97210
United States
Site 60
Anderson, South Carolina, 29625
United States
Site 76
Austin, Texas, 78746
United States
Site 51
Austin, Texas, 78759
United States
Site 67
Dallas, Texas, 75230
United States
Site 78
Plano, Texas, 75024
United States
Site 63
Norfolk, Virginia, 23502
United States
Site 70
Mill Creek, Washington, 98012
United States

Collaborators and Investigators

Sponsor: Veradermics, Inc.

  • Reid Waldman, M.D., STUDY_CHAIR, Veradermics, Inc.
  • Timothy Durso, M.D., STUDY_CHAIR, 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 Date2025-03-11
Study Completion Date2026-11

Study Record Updates

Study Start Date2025-03-11
Study Completion Date2026-11

Terms related to this study

Keywords Provided by Researchers

  • Hair Loss
  • Male Hair Loss

Additional Relevant MeSH Terms

  • Androgenetic Alopecia
  • AGA
  • Male Pattern Baldness