RECRUITING

Safety and Efficacy of VDPHL01 in Females With Androgenetic Alopecia (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 female subjects with Androgenetic Alopecia (AGA). AGA is a genetic disorder caused by an excessive (too much) hair follicle response to androgens (hormones) that causes hair loss. VDPHL01 is an investigational oral drug to treat AGA. 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 Female Subjects With Androgenetic Alopecia

Quick Facts

Study Start:2025-07-25
Study Completion:2027-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07146022

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:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subject is a female 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 and can read, understand, and complete the 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 baseline;
  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

AGA Study Manager
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 89
Birmingham, Alabama, 35244
United States
Site 77
Phoenix, Arizona, 85006
United States
Site 30
Fort Smith, Arkansas, 72916
United States
Site 69
Encino, California, 91436
United States
Site 2
Fremont, California, 94538
United States
Site 64
Manhattan Beach, California, 90266
United States
Site 93
Northridge, California, 91324
United States
Site 66
Santa Monica, California, 90404
United States
Site 34
Sherman Oaks, California, 91403
United States
Site 94
Thousand Oaks, California, 91320
United States
Site 21
Vista, California, 92083
United States
Site 5
Castle Rock, Colorado, 80109
United States
Site 24
Greenwood Village, Colorado, 80111
United States
Site 17
Aventura, Florida, 33180
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 99
Miami, Florida, 33173
United States
Site 54
Ocala, Florida, 34470
United States
Site 43
Atlanta, Georgia, 30329
United States
Site 90
Sandy Springs, Georgia, 30328
United States
Site 31
Boise, Idaho, 83704
United States
Site 53
Clarksville, Indiana, 47129
United States
Site 15
Indianapolis, Indiana, 46250
United States
Site 32
New Albany, Indiana, 47150
United States
Site 55
Plainfield, Indiana, 46168
United States
Site 27
West Lafayette, Indiana, 47906
United States
Site 79
Leawood, Kansas, 66211
United States
Site 52
Louisville, Kentucky, 40241
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 75
New Orleans, Louisiana, 70124
United States
Site 84
Glenn Dale, Maryland, 20769
United States
Site 87
Rockville, Maryland, 20850
United States
Site 22
Brighton, Massachusetts, 02135
United States
Site 80
Chestnut Hill, Massachusetts, 02467
United States
Site 59
Quincy, Massachusetts, 02169
United States
Site 26
Clarkston, Michigan, 48346
United States
Site 68
Clinton Township, Michigan, 48038
United States
Site 56
Minneapolis, Minnesota, 55455
United States
Site 6
New Brighton, Minnesota, 55112
United States
Site 18
Hackensack, New Jersey, 07601
United States
Site 37
Kew Gardens, New York, 11415
United States
Site 82
Hickory, North Carolina, 28602
United States
Site 92
Huntersville, North Carolina, 28078
United States
Site 39
Boardman, Ohio, 44512
United States
Site 72
Cincinnati, Ohio, 45236
United States
Site 11
Columbus, Ohio, 43215
United States
Site 57
Portland, Oregon, 97210
United States
Site 60
Anderson, South Carolina, 29621
United States
Site 95
Hermitage, Tennessee, 37076
United States
Site 9
Knoxville, Tennessee, 37909
United States
Site 4
Nashville, Tennessee, 37215
United States
Site 76
Austin, Texas, 78746
United States
Site 74
College Station, Texas, 77845
United States
Site 14
Houston, Texas, 77056
United States
Site 88
San Antonio, Texas, 78218
United States
Site 91
Sugar Land, Texas, 77479
United States
Site 19
South Jordan, Utah, 84095
United States
Site 29
Forest, Virginia, 24551
United States
Site 63
Norfolk, Virginia, 23502
United States
Site 85
Norfolk, Virginia, 23502
United States
Site 33
Burien, Washington, 98168
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 Date2025-07-25
Study Completion Date2027-03

Study Record Updates

Study Start Date2025-07-25
Study Completion Date2027-03

Terms related to this study

Keywords Provided by Researchers

  • Androgenetic Alopecia
  • AGA
  • Hair Loss

Additional Relevant MeSH Terms

  • Androgenetic Alopecia (AGA)
  • Androgenetic Alopecia
  • AGA
  • Female Androgenetic Alopecia
  • Hair Loss