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Non-segmental VitiligoPhase 2NCT06493578

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VYN201 Gel in Subjects With Non-segmental Vitiligo.

A Phase 2 study testing VYN201 Gel in people with Non-segmental Vitiligo, run by Vyne Therapeutics Inc. at 49 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of VYN201 Gel in subjects with non-segmental vitiligo. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non-segmental Vitiligo
What is being tested?
VYN201 Gel
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
205 participants
Where
49 sitesin 2 countries
Study dates
4 Jun 2024to 30 Sep 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has completed and signed an Informed Consent Form (ICF) prior to any study-related procedures.
  • Able to understand and comply with study requirements.
  • Male or female aged 18 to 75 years, inclusive.
  • Clinical diagnosis of non-segmental vitiligo where the total affected BSA does not exceed 10%.
  • F-VASI score of ≥0.5 and ≤3.0.
  • T-VASI score of ≥3.0 and ≤10.0.
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  • Agree to discontinue all agents used to treat vitiligo from Screening through the study completion. Over-the-counter preparations deemed acceptable by the investigator are permitted.
  • If receiving concomitant medication for any reason other than vitiligo, must be on a stable regimen at Screening, and anticipating staying on a stable regimen through the study completion.
  • Female participants must:
  • Be of non-childbearing potential (i.e., surgically sterilized [hysterectomy, bilateral salpingectomy, bilateral oophorectomy, tubal ligation/occlusion at least 6 weeks before the Screening]) or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause) OR
  • If of childbearing potential, must agree not to donate ova, not to attempt to become pregnant and, if engaging in sexual intercourse with a male partner, must agree to use an acceptable method of contraception from signing the ICF until at least 1 month after the last dose of IMP. An acceptable method of contraception includes one of the following:
  • Hormonal contraception (for at least 3 months prior to Screening) in combination with a barrier method.
  • Intrauterine device (placement at least 3 months prior to Screening).
  • Diaphragm with spermicide.
  • Cervical cap with spermicide.
  • Condoms with spermicide.
  • Vasectomized partner (6 months minimum since vasectomy).
  • Male participants, if not biologically or surgically sterilized, must agree not to donate sperm and, if engaging in sexual intercourse, must agree to use a condom from signing the ICF until at least 1 month after the last dose of study drug. If engaging with a female partner who could become pregnant, the female partner must additionally use an acceptable method of contraception for this same period.

Who cannot join

  • Clinical diagnosis of other forms of vitiligo (e.g., segmental) or other hypo- or de-pigmentation skin diseases (e.g., piebaldism, leukoderma, Vogt-Koyanagi-Harada disease, malignancy induced hypopigmentation, etc.).
  • Concomitant dermatologic conditions or other medical condition(s) which may, in the opinion of the investigator, interfere with IMP application or study assessments.
  • History of melanocyte transplantation procedure or depigmentation treatment [e.g. Monobenzyl ether of hydroquinone (Monobenzone)].
  • Visible test site skin injury, damage, or observations in or around the application site which, in the opinion of the investigator, will interfere with study assessments or increase participation risk.
  • Dyed hair in the treatment area that could interfere with any clinical assessments.
  • Significant facial hair or are unable to maintain very short cropped facial hair (<5mm) during course of the study.
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  • Leukotrichia in >33% of vitiligo lesional surface of the face or the body.
  • History or presence of any clinically significant condition(s) which, in the opinion of the investigator, could interfere with the course of the study or expose the participant to undue risk by participating in this study, including, but not limited to: metabolic, allergic, cardiovascular, pulmonary, hepatic, renal, hematologic (including bleeding disorders), gastrointestinal (including peptic ulcer disease, gastritis or bleeding diathesis, excluding appendectomy or hernia repair), endocrine, immunologic, dermatologic, muscular, neurological, psychiatric, neoplastic, or other disease(s).
  • Major surgery within 3 months of randomization or with planned major surgery during trial.
  • Current or recent history (<30 days before Screening and/or <45 days before randomization) of a clinically meaningful bacterial, fungal, parasitic, or mycobacterial infection.
  • Any known or suspected premalignant or malignant disease within 5 years prior to Screening (excluding successfully treated basal or squamous cell carcinomas, actinic keratoses, melanoma in situ, cervical dysplasias, cervical cancer).
  • Systemic biologic or immune-modulating treatment within 12 weeks prior to Screening and through study completion or topical treatment in the vitiligo areas within 2 weeks prior to Screening and through study completion.
  • Received any investigational therapy, device or procedure within 30 days or 5 half-lives (whichever is longer) prior to Screening. Investigational biologics should be discussed with the sponsor to determine if a longer period of discontinuation is required.
  • Relevant (in the investigator opinion) ultraviolet light exposure including phototherapy within 8 weeks prior to Screening.
  • Use of any other prior and concomitant therapy not listed above that, in the opinion of the investigator, may interfere with the evaluation of study outcomes, including drugs that cause photosensitivity or skin pigmentation (e.g. antibiotics such as tetracyclines, antifungals). These medications should be discontinued within 4 weeks of randomization.
  • Known or suspected history of alcohol or drug abuse within 12 months of Screening or in the opinion of the investigator, will interfere with the subject's ability to comply with the administration schedule and study assessments (alcohol abuse is defined as regular consumption of >10 standard units of alcohol per week).
  • Subjects who are pregnant or breastfeeding.
  • Clinically significant abnormal laboratory values at Screening:
  • Neutrophils < lower limit of normal.
  • Hemoglobin < 10 g/dL.
  • Platelets < 100 × 109/L.
  • Alanine transaminase (ALT) or aspartate transaminase (AST) ≥ 2.0 × upper limit of normal.
  • Estimated creatinine clearance < 30 mL/min or renal disease requiring dialysis as determined by Cockcroft-Gault.
  • Positive serology tests for Hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV), or human immunodeficiency virus (HIV)-1 and HIV-2 antibody.
  • Subjects who received a live vaccine within 4 weeks prior to Screening.
  • Subjects with known allergy or reaction to any component of the study formulation.

Trial locations and contacts

49 sites in 2 countries.

49 sites in 2 countries

United States42 sites

  • Arlington Research Center

    Arlington, Texas, 76011

  • Cahaba Dermatology & Skin Health Center

    Birmingham, Alabama, 35244

  • Skin Care Research

    Boca Raton, Florida, 33486

  • Clarity Dermatology

    Canal Winchester, Ohio, 80109

  • Clarity Dermatology

    Castle Rock, Colorado, 80109

  • MetroMed Clinical Trials

    Chicago, Illinois, 60614

  • DS Research of Southern Indiana

    Clarksville, Indiana, 47129

  • Driven Research LLC

    Coral Gables, Florida, 33134

  • Dermatology Treatment and Research Center

    Dallas, Texas, 75230

  • Colorado Medical Research Center

    Denver, Colorado, 80210

  • Newco 3A Research

    El Paso, Texas, 79902

  • California Dermatology & Clinical Research Institute

    Encinitas, California, 92024

  • Clinical Trial Institute of Northwest Arkansas, LLC

    Fayetteville, Arkansas, 72703

  • First OC Dermatology Research, Inc

    Fountain Valley, California, 92708

  • Center for Dermatology Clinical Research, Inc

    Fremont, California, 94538

  • Cumberland Skin Center for Clinical Research

    Hermitage, Tennessee, 37076

  • Hickory Dermatology Research Center

    Hickory, North Carolina, 28602

  • Skin Care Research

    Hollywood, Florida, 33021

  • Burke Pharmaceutical Research

    Hot Springs, Arkansas, 71913

  • Center for Clinical Studies, LTD.LLP

    Houston, Texas, 77004

  • Marvel Clinical Research

    Huntington Beach, California, 92647

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana, 46250

  • JDR Dermatology Research

    Las Vegas, Nevada, 89148

  • DS Research of Kentucky

    Louisville, Kentucky, 40241

  • The Skin Center Dermatology Group

    New City, New York, 10956

  • DelRicht Research at Audubon Dermatology

    New Orleans, Louisiana, 70115

  • Bobby Buka MD, PC

    New York, New York, 10012

  • Northridge Clinical Trials

    Northridge, California, 91325

  • Central Sooner Research

    Oklahoma City, Oklahoma, 73170

  • Palmtree Clinical Research, Inc.

    Palm Springs, California, 92262

  • Austin Insitute for Clinical Research

    Pflugerville, Texas, 78660

  • Saguaro Dermatology

    Phoenix, Arizona, 85008

  • Dermatology Associates of Plymouth Meeting

    Plymouth Meeting, Pennsylvania, 19462

  • DelRicht Research at Lockhart Matter Dermatology

    Prosper, Texas, 75078

  • Lawrence J. Green, MD LLC

    Rockville, Maryland, 20850

  • Integrative Skin Science and Research

    Sacramento, California, 95815

  • International Clinical Research - FL LLC

    Sanford, Florida, 32771

  • Center for Dermatology and Plastic Surgery/CCT Research

    Scottsdale, Arizona, 85260

  • Jordan Valley Dermatology Center

    South Jordan, Utah, 84095

  • Noble Clinical Research

    Tucson, Arizona, 85704

  • Metabolic Research Institute, Inc

    West Palm Beach, Florida, 33401

  • The Skin Surgery Center for Clinical Research

    Winston-Salem, North Carolina, 27103

Other trials in United States

Canada7 sites

  • SimcoDerm Medical and Surgical Dermatology Center

    Barrie, Ontario, L4M 7G1

  • Dermatology Research Institute

    Calgary, Alberta, T2J 7E1

  • Lynderm Research Inc.

    Markham, Ontario, L3P 1X3

  • Siena Medical Research

    Montreal, Quebec, H3Z 2S6

  • JRB Research Inc

    Ottawa, Ontario, K1KL2

  • SKiN Centre for Dermatology

    Peterborough, Ontario, K9J 5K2

  • Research Toronto

    Toronto, Ontario, M4W 2N4

Other trials in Canada

About this study

Official title: A Randomized, Double-Blind, Vehicle-Controlled Phase 2b Trial Evaluating the Efficacy, Safety & Pharmacokinetics of VYN201 Gel in the Treatment of Non Segmental Vitiligo

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of VYN201 Gel in subjects with non-segmental vitiligo.

Being tested
VYN201 Gel, Vehicle Gel
Keywords
NSV, VYN201 Gel, vitiligo
Medical subject headings
Vitiligo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VYN201 GelDrug

    VYN201 Gel is a topical formulation applied as a thin layer to affected areas.

  • Vehicle GelDrug

    Vehicle gel (placebo) is matching in appearance to VYN201 gel and is to be applied in the same manner as VYN201 gel.

Study groups in NCT06493578
Study groupRoleWhat they receive
Low dose VYN201 (1.0%)Active comparatorSubjects will apply VYN201 1.0% once daily on affected vitiligo areas. The first part of the study will be a 24-week, double-blind, vehicle controlled treatment period. Following, the second part will be a 28-week, double-blind treatment extension period, with a 4-week safety follow-up period after the last investigational medicinal product (IMP) dose. After completion of the Week 24 assessments, subjects randomized to 1.0% will remain and continue on the same dose until Week 52.
Receives: Drug: VYN201 Gel
Mid dose VYN201 (2.0%)Active comparatorSubjects will apply VYN201 2.0% once daily on affected vitiligo areas. The first part of the study will be a 24-week, double-blind, vehicle controlled treatment period. Following, the second part will be a 28-week, double-blind treatment extension period, with a 4-week safety follow-up period after the last investigational medicinal product (IMP) dose. After completion of the Week 24 assessments, subjects randomized to 2.0% will remain and continue on the same dose until Week 52.
Receives: Drug: VYN201 Gel
High dose VYN201 (3.0%)Active comparatorSubjects will apply VYN201 3.0% once daily on affected vitiligo areas. The first part of the study will be a 24-week, double-blind, vehicle controlled treatment period. Following, the second part will be a 28-week, double-blind treatment extension period, with a 4-week safety follow-up period after the last investigational medicinal product (IMP) dose. After completion of the Week 24 assessments, subjects randomized to 3.0% will remain and continue on the same dose until Week 52.
Receives: Drug: VYN201 Gel
VehiclePlacebo comparatorSubjects will apply VYN201 vehicle (placebo) once daily on affected vitiligo areas. The first part of the study will be a 24-week, double-blind, vehicle controlled treatment period. Following, the second part will be a 28-week, double-blind treatment extension period, with a 4-week safety follow-up period after the last investigational medicinal product (IMP) dose. After completion of the Week 24 assessments, subjects randomized to vehicle (placebo) will be re-randomized to 1 of the 3 higher VYN201 (active) dose groups (1.0%, 2.0% or 3.0% once daily) in a 1:1:1 ratio while maintaining the blind until Week 52.
Receives: Drug: VYN201 Gel; Drug: Vehicle Gel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To evaluate the efficacy of VYN201 compared to vehicle at Week 24 in subjects with NSV.

    Proportion of subjects who achieve a ≥50% improvement from Baseline in F-VASI score at Week 24.

    Measured: Week 24

Secondary outcomes (2)

  1. To evaluate the efficacy of VYN201 as measured by F-VASI over time in subjects with NSV.

    Mean and percent changes from Baseline in F-VASI at Week 24 and Week 52.

    Measured: Week 24 and Week 52

  2. To evaluate the efficacy of VYN201 as measured by T-VASI assessment over time in subjects with NSV.

    Proportion of subjects who achieve a ≥50% improvement from baseline in T-VASI at Week 52

    Measured: Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2024
  2. Study start4 Jun 2024
  3. Primary completion10 Jul 2025
  4. Study completion30 Sep 2025

Why it stopped: Business Decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
205 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06493578
Sponsor's protocol ID
VY2024-02
Status last verified
Apr 2026
First submitted
18 Mar 2024
Last updated
21 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing VYN201 Gel in people with Non-segmental Vitiligo, run by Vyne Therapeutics Inc. at 49 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Business Decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the efficacy of VYN201 compared to vehicle at Week 24 in subjects with NSV. (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06493578.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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