ACTIVE_NOT_RECRUITING

Efficacy and Safety 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). The first 7 visits will be part of the placebo-controlled period. The next 3 visits will be part of the treatment extension phase. All subjects will receive active drug in the treatment extension phase.

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:2024-11-06
Study Completion:2026-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06724614

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 normal 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

Principal Investigator

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

Study Locations (Sites)

Site 36
Birmingham, Alabama, 35203
United States
Site 28
Phoenix, Arizona, 85018
United States
Site 30
Fort Smith, Arkansas, 72916
United States
Site 35
Rogers, Arkansas, 72758
United States
Site 07
Fountain Valley, California, 92728
United States
Site 02
Fremont, California, 94538
United States
Site 34
Sherman Oaks, California, 91403
United States
Site 21
Vista, California, 92083
United States
Site 05
Castle Rock, Colorado, 80109
United States
Site 24
Englewood, Colorado, 80111
United States
Site 17
Aventura, Florida, 33180
United States
Site 25
Brandon, Florida, 33511
United States
Site 42
Hollywood, Florida, 33021
United States
Site 03
Tampa, Florida, 33613
United States
Site 43
Atlanta, Georgia, 30329
United States
Site 31
Boise, Idaho, 83704
United States
Site 23
Rolling Meadows, Illinois, 60008
United States
Site 15
Indianapolis, Indiana, 46250
United States
Site 32
New Albany, Indiana, 47150
United States
Site 27
West Lafayette, Indiana, 47906
United States
Site 41
Baton Rouge, Louisiana, 70809
United States
Site 13
Covington, Louisiana, 70433
United States
Site 12
Metairie, Louisiana, 70006
United States
Site 22
Brighton, Massachusetts, 02135
United States
Site 26
Clarkston, Michigan, 48346
United States
Site 06
New Brighton, Minnesota, 55112
United States
Site 18
Hackensack, New Jersey, 07601
United States
Site 37
Kew Gardens, New York, 11415
United States
Site 38
New York, New York, 10075
United States
Site 39
Boardman, Ohio, 44512
United States
Site 11
Columbus, Ohio, 43215
United States
Site 08
Broomall, Pennsylvania, 19073
United States
Site 10
Plymouth Meeting, Pennsylvania, 19462
United States
Site 20
Greensville, South Carolina, 29615
United States
Site 09
Knoxville, Tennessee, 37909
United States
Site 16
Murfreesboro, Tennessee, 37130
United States
Site 04
Nashville, Tennessee, 37215
United States
Site 40
Bellaire, Texas, 77401
United States
Site 44
Dallas, Texas, 75231
United States
Site 14
Houston, Texas, 77056
United States
Site 19
West Jordan, Utah, 84095
United States
Site 29
Lynchburg, Virginia, 24501
United States
Site 33
Seattle, Washington, 98168
United States
Site 01
Spokane, Washington, 99202
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 Date2024-11-06
Study Completion Date2026-07

Study Record Updates

Study Start Date2024-11-06
Study Completion Date2026-07

Terms related to this study

Keywords Provided by Researchers

  • Hair Loss
  • Male Hair Loss

Additional Relevant MeSH Terms

  • Androgenetic Alopecia
  • AGA
  • Male Pattern Baldness