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Active, not recruitingNCT07146022Updated Aug 17, 2026

Safety and Efficacy of VDPHL01 in Females With Androgenetic Alopecia (AGA)

A Phase 3 interventional study of VDPHL01 QD and Placebo in Androgenetic Alopecia (AGA), Androgenetic Alopecia and AGA, sponsored by Veradermics, Inc.. Active, not recruiting at 71 sites in United States. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-17.

Sponsored by Veradermics, Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
552
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Female
01

Study summary

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).

Read the detailed description

Not required.

02

Conditions studied

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

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Keywords

  • Androgenetic Alopecia
  • AGA
  • Hair Loss
03

In context

Alopecia

609 studies on the registry are indexed under Alopecia; 131 are open to participants now.

This study's planned enrollment of 552 is above the median of 45 across 513 interventional studies indexed under Alopecia.

Browse Alopecia studies →

Lead sponsor

Veradermics, Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Subject is a female aged 18-65 years old;
  • Subject has a clinical diagnosis of mild to moderate AGA;
  • Subject is in good general health and has adequate 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 and can read, understand, and complete the required questionnaires in English;
  • Subject is willing and able to swallow study drug whole;
  • 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.

Exclusion criteria

Exclusion Criteria:

  • Subject has uncontrolled blood pressure or orthostatic hypotension;
  • Subject has symptoms or history of certain heart or thyroid conditions;
  • Subject has a history of or active hair loss due to conditions/diseases other than AGA;
  • Subject has a current or recent history of dietary or weight changes, including use of GLP-1 agonists;
  • Subject has been diagnosed with COVID-19 within 16 weeks of baseline;
  • Subject has had previous radiation of the scalp;
  • Use of any of the following treatments within the indicated washout period before screening:

    • Subject has used hormone replacement therapy or hormonal modulators within 6 months prior to screening
    • Subject has used oral treatments for hair growth or that can affect hair growth, including systemic retinoids, within 6 months of screening
    • Subject has used systemic calcium channel blockers or beta blockers within 12 weeks prior to screening
    • Subject has used systemic cimetidine, ketoconazole, diazoxide, or corticosteroids (including intramuscular, intraarticular, and intralesional injections) within 12 weeks prior to screening
    • 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
    • Subject has used any topical scalp treatments for hair growth within 12 weeks 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;
    • Subject has any other condition that, in the investigator's opinion, interfere with the study
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
552 participants (estimated)

Study arms

  • Experimental
    VDPHL01 BID

    VDPHL01 will be taken orally twice a day (BID), once in the AM and once in the PM for the first 6 months of the study. After month 6, subject will continue VDPHL01 BID for an additional 6 months.

    Drug: VDPHL01 BID

  • Experimental
    VDPHL01 QD and Placebo QD

    Placebo will be taken orally once a day (QD) in the AM or PM. VDPHL01 will be taken orally once a day (QD) in the AM or PM for the first 6 months of the study. After month 6, subject will continue this same dose regimen for an additional 6 months.

    Drug: VDPHL01 QD · Drug: Placebo

  • Placebo comparator
    Placebo BID with treatment extension to VDPHL01 BID

    Placebo will be taken orally twice a day (BID), once in the AM and once in the PM for the first 6 months of the study. After month 6, subject will switch to VDPHL01 BID group, and take VDPHL01 orally twice a day (BID), once in the AM and once in the PM for an additional 6 months.

    Drug: Placebo

  • Placebo comparator
    Placebo BID with treatment extension to VDPHL01 QD and Placebo QD

    Placebo will be taken orally twice a day (BID), once in the AM and once in the PM for the first 6 months of the study. After month 6, subject will switch to VDPHL01 QD and Placebo QD group, and take placebo orally once a day in the AM or PM; VDPHL01 will be taken orally once a day in the AM or PM for an additional 6 months.

    Drug: Placebo

Interventions

  • DrugVDPHL01 QD

    VDPHL01 Extended Release (ER) Tablet

  • DrugPlacebo

    Placebo tablet

  • DrugVDPHL01 BID

    VDPHL01 Extended Release (ER) Tablet

  • DrugPlacebo

    Placebo tablet

06

What researchers measure

Primary outcomes

  1. Changes in non-vellus Target Area Hair Counts (TAHC)

    Changes from baseline in non-vellus TAHC using digital image analysis at Month 6.

    Time frame: Month 6

  2. 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 6.

    Time frame: Month 6

07

Study locations

71 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 61
    Chicago, Illinois 60610, 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 83
    Southfield, Michigan 48034, United States
  • Site 98
    Medina, Minnesota 55340, 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 97
    New York, New York 10003, 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 67
    Dallas, Texas 75230, 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
08

References and documents

Related links

Individual participant data

Plan to share: Undecided — The sponsor is undecided if this information will be shared at this time. This field will be updated when a decision is made.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07146022
Lead sponsor
Veradermics, Inc.
Responsible party
Sponsor
First posted
Aug 28, 2025
Start date
Jul 25, 2025
Primary completion
Jun 2027 (estimated)
Completion
Jan 2028 (estimated)
Last update
Aug 17, 2026

Study contacts

Reid Waldman, M.D.
study chair · Veradermics, Inc.
Timothy Durso, M.D.
study chair · Veradermics, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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