Home › Trials › NCT06493578

Evaluating VYN201 Gel for treating non-segmental vitiligo

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

Phase 2 Interventional Vyne Therapeutics Inc. · NCT06493578

This study is testing a new gel called VYN201 to see if it can help adults with non-segmental vitiligo improve their skin condition and if it has any side effects.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment160 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorVyne Therapeutics Inc. Industry-sponsored
Locations48 sites (Birmingham, Alabama and 47 other locations)
Trial IDNCT06493578 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy, safety, and pharmacokinetics of VYN201 Gel in individuals diagnosed with non-segmental vitiligo. Participants will apply the gel and be monitored for its effects on their skin condition, with a focus on how well it works and any potential side effects. The study will include adults aged 18 to 75 who meet specific criteria regarding the severity of their vitiligo. The research will also involve a comparison with a vehicle gel to determine the effectiveness of the treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with a clinical diagnosis of non-segmental vitiligo affecting no more than 10% of their body surface area.

Not a fit: Patients with extensive vitiligo or those currently using other treatments for their condition may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the skin appearance and quality of life for patients with non-segmental vitiligo.

How similar studies have performed: While there have been studies on various treatments for vitiligo, the specific approach using VYN201 Gel is novel and has not been extensively tested in prior research.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Birmingham, Alabama and 47 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Non-segmental VitiligoNSVVYN201 Gelvitiligo
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.