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

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.