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New gel shows promise for vitiligo, but study halted early

NCT ID NCT06493578

Disease control Sponsor: Vyne Therapeutics Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a gel called VYN201 for people with non-segmental vitiligo, a condition that causes white patches on the skin. The goal was to see if the gel could reduce the size of these patches over 24 weeks. The trial involved 205 adults aged 18 to 75, but it was terminated early, so results are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

205 people

The number who actually took part.

Started

Jun 2024

Finished

Sep 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Has completed and signed an Informed Consent Form (ICF) prior to any study-related procedures. 2. Able to understand and comply with study requirements. 3. Male or female aged 18 to 75 years, inclusive. 4. Clinical diagnosis of non-segmental vitiligo where the total affected BSA does not exceed 10%. 5. F-VASI score of ≥0.5 and ≤3.0. 6. T-VASI score of ≥3.0 and ≤10.0. 7. 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. 8. 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. 9. 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: 1. Hormonal contraception (for at least 3 months prior to Screening) in combination with a barrier method. 2. Intrauterine device (placement at least 3 months prior to Screening). 3. Diaphragm with spermicide. 4. Cervical cap with spermicide. 5. Condoms with spermicide. 6. Vasectomized partner (6 months minimum since vasectomy). 10. 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. Exclusion Criteria: 1. 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.). 2. Concomitant dermatologic conditions or other medical condition(s) which may, in the opinion of the investigator, interfere with IMP application or study assessments. 3. History of melanocyte transplantation procedure or depigmentation treatment \[e.g. Monobenzyl ether of hydroquinone (Monobenzone)\]. 4. 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. 5. Dyed hair in the treatment area that could interfere with any clinical assessments. 6. Significant facial hair or are unable to maintain very short cropped facial hair (\<5mm) during course of the study. 7. Leukotrichia in \>33% of vitiligo lesional surface of the face or the body. 8. 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). 9. Major surgery within 3 months of randomization or with planned major surgery during trial. 10. Current or recent history (\<30 days before Screening and/or \<45 days before randomization) of a clinically meaningful bacterial, fungal, parasitic, or mycobacterial infection. 11. 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). 12. 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. 13. 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. 14. Relevant (in the investigator opinion) ultraviolet light exposure including phototherapy within 8 weeks prior to Screening. 15. 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. 16. 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). 17. Subjects who are pregnant or breastfeeding. 18. Clinically significant abnormal laboratory values at Screening: 1. Neutrophils \< lower limit of normal. 2. Hemoglobin \< 10 g/dL. 3. Platelets \< 100 × 109/L. 4. Alanine transaminase (ALT) or aspartate transaminase (AST) ≥ 2.0 × upper limit of normal. 5. Estimated creatinine clearance \< 30 mL/min or renal disease requiring dialysis as determined by Cockcroft-Gault. 6. 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. 19. Subjects who received a live vaccine within 4 weeks prior to Screening. 20. Subjects with known allergy or reaction to any component of the study formulation.

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Conditions

The condition(s) this trial relates to.

vitiligo

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-segmental vitiligo

Contacts and locations

Locations

  • Arlington Research Center

    Arlington, Texas, 76011, United States

  • Austin Insitute for Clinical Research

    Pflugerville, Texas, 78660, United States

  • Bobby Buka MD, PC

    New York, New York, 10012, United States

  • Burke Pharmaceutical Research

    Hot Springs, Arkansas, 71913, United States

  • Cahaba Dermatology & Skin Health Center

    Birmingham, Alabama, 35244, United States

  • California Dermatology & Clinical Research Institute

    Encinitas, California, 92024, United States

  • Center for Clinical Studies, LTD.LLP

    Houston, Texas, 77004, United States

  • Center for Dermatology Clinical Research, Inc

    Fremont, California, 94538, United States

  • Center for Dermatology and Plastic Surgery/CCT Research

    Scottsdale, Arizona, 85260, United States

  • Central Sooner Research

    Oklahoma City, Oklahoma, 73170, United States

  • Clarity Dermatology

    Castle Rock, Colorado, 80109, United States

  • Clarity Dermatology

    Canal Winchester, Ohio, 80109, United States

  • Clinical Trial Institute of Northwest Arkansas, LLC

    Fayetteville, Arkansas, 72703, United States

  • Colorado Medical Research Center

    Denver, Colorado, 80210, United States

  • Cumberland Skin Center for Clinical Research

    Hermitage, Tennessee, 37076, United States

  • DS Research of Kentucky

    Louisville, Kentucky, 40241, United States

  • DS Research of Southern Indiana

    Clarksville, Indiana, 47129, United States

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana, 46250, United States

  • DelRicht Research at Audubon Dermatology

    New Orleans, Louisiana, 70115, United States

  • DelRicht Research at Lockhart Matter Dermatology

    Prosper, Texas, 75078, United States

  • Dermatology Associates of Plymouth Meeting

    Plymouth Meeting, Pennsylvania, 19462, United States

  • Dermatology Research Institute

    Calgary, Alberta, T2J 7E1, Canada

  • Dermatology Treatment and Research Center

    Dallas, Texas, 75230, United States

  • Driven Research LLC

    Coral Gables, Florida, 33134, United States

  • First OC Dermatology Research, Inc

    Fountain Valley, California, 92708, United States

  • Hickory Dermatology Research Center

    Hickory, North Carolina, 28602, United States

  • Integrative Skin Science and Research

    Sacramento, California, 95815, United States

  • International Clinical Research - FL LLC

    Sanford, Florida, 32771, United States

  • JDR Dermatology Research

    Las Vegas, Nevada, 89148, United States

  • JRB Research Inc

    Ottawa, Ontario, K1KL2, Canada

  • Jordan Valley Dermatology Center

    South Jordan, Utah, 84095, United States

  • Lawrence J. Green, MD LLC

    Rockville, Maryland, 20850, United States

  • Lynderm Research Inc.

    Markham, Ontario, L3P 1X3, Canada

  • Marvel Clinical Research

    Huntington Beach, California, 92647, United States

  • Metabolic Research Institute, Inc

    West Palm Beach, Florida, 33401, United States

  • MetroMed Clinical Trials

    Chicago, Illinois, 60614, United States

  • Newco 3A Research

    El Paso, Texas, 79902, United States

  • Noble Clinical Research

    Tucson, Arizona, 85704, United States

  • Northridge Clinical Trials

    Northridge, California, 91325, United States

  • Palmtree Clinical Research, Inc.

    Palm Springs, California, 92262, United States

  • Research Toronto

    Toronto, Ontario, M4W 2N4, Canada

  • SKiN Centre for Dermatology

    Peterborough, Ontario, K9J 5K2, Canada

  • Saguaro Dermatology

    Phoenix, Arizona, 85008, United States

  • Siena Medical Research

    Montreal, Quebec, H3Z 2S6, Canada

  • SimcoDerm Medical and Surgical Dermatology Center

    Barrie, Ontario, L4M 7G1, Canada

  • Skin Care Research

    Boca Raton, Florida, 33486, United States

  • Skin Care Research

    Hollywood, Florida, 33021, United States

  • The Skin Center Dermatology Group

    New City, New York, 10956, United States

  • The Skin Surgery Center for Clinical Research

    Winston-Salem, North Carolina, 27103, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.