A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VYN201 Gel in Subjects With Non-segmental Vitiligo.
NCT ID: NCT06493578
Last Updated: 2025-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE2
200 participants
INTERVENTIONAL
2024-06-04
2026-01-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Trial of SHR0302 Tablets and SHR0302 Base Gel in Patients With Non-segmental Vitiligo
NCT07251595
A Trial of SHR0302Base in Patients With Vitiligo
NCT06790862
Safety and Efficacy of ARQ-252 Cream 0.3% in Subjects With Non-Segmental Facial Vitiligo
NCT04811131
Safety and Tolerability Study of Cerdulatinib Gel, 0.37% in Adults With Vitiligo
NCT04103060
Effect of Early Systemic Stabilization Therapy on Recent Onset Vitiligo
NCT05037981
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Low dose VYN201 (1.0%)
Subjects 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.
VYN201 Gel
VYN201 Gel is a topical formulation applied as a thin layer to affected areas.
Mid dose VYN201 (2.0%)
Subjects 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.
VYN201 Gel
VYN201 Gel is a topical formulation applied as a thin layer to affected areas.
High dose VYN201 (3.0%)
Subjects 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.
VYN201 Gel
VYN201 Gel is a topical formulation applied as a thin layer to affected areas.
Vehicle
Subjects 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.
VYN201 Gel
VYN201 Gel is a topical formulation applied as a thin layer to affected areas.
Vehicle Gel
Vehicle gel (placebo) is matching in appearance to VYN201 gel and is to be applied in the same manner as VYN201 gel.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
VYN201 Gel
VYN201 Gel is a topical formulation applied as a thin layer to affected areas.
Vehicle Gel
Vehicle gel (placebo) is matching in appearance to VYN201 gel and is to be applied in the same manner as VYN201 gel.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Vyne Therapeutics Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cahaba Dermatology & Skin Health Center
Birmingham, Alabama, United States
Saguaro Dermatology
Phoenix, Arizona, United States
Center for Dermatology and Plastic Surgery/CCT Research
Scottsdale, Arizona, United States
Noble Clinical Research
Tucson, Arizona, United States
Clinical Trial Institute of Northwest Arkansas, LLC
Fayetteville, Arkansas, United States
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States
California Dermatology & Clinical Research Institute
Encinitas, California, United States
First OC Dermatology Research, Inc
Fountain Valley, California, United States
Center for Dermatology Clinical Research, Inc
Fremont, California, United States
Marvel Clinical Research
Huntington Beach, California, United States
Northridge Clinical Trials
Northridge, California, United States
Palmtree Clinical Research, Inc.
Palm Springs, California, United States
Integrative Skin Science and Research
Sacramento, California, United States
Clarity Dermatology
Castle Rock, Colorado, United States
Colorado Medical Research Center
Denver, Colorado, United States
Skin Care Research
Boca Raton, Florida, United States
Driven Research LLC
Coral Gables, Florida, United States
Skin Care Research
Hollywood, Florida, United States
International Clinical Research - FL LLC
Sanford, Florida, United States
Metabolic Research Institute, Inc
West Palm Beach, Florida, United States
MetroMed Clinical Trials
Chicago, Illinois, United States
DS Research of Southern Indiana
Clarksville, Indiana, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
DS Research of Kentucky
Louisville, Kentucky, United States
DelRicht Research at Audubon Dermatology
New Orleans, Louisiana, United States
Lawrence J. Green, MD LLC
Rockville, Maryland, United States
JDR Dermatology Research
Las Vegas, Nevada, United States
The Skin Center Dermatology Group
New City, New York, United States
Bobby Buka MD, PC
New York, New York, United States
Hickory Dermatology Research Center
Hickory, North Carolina, United States
The Skin Surgery Center for Clinical Research
Winston-Salem, North Carolina, United States
Clarity Dermatology
Canal Winchester, Ohio, United States
Central Sooner Research
Oklahoma City, Oklahoma, United States
Dermatology Associates of Plymouth Meeting
Plymouth Meeting, Pennsylvania, United States
Cumberland Skin Center for Clinical Research
Hermitage, Tennessee, United States
Arlington Research Center
Arlington, Texas, United States
Dermatology Treatment and Research Center
Dallas, Texas, United States
Newco 3A Research
El Paso, Texas, United States
Center for Clinical Studies, LTD.LLP
Houston, Texas, United States
Austin Insitute for Clinical Research
Pflugerville, Texas, United States
DelRicht Research at Lockhart Matter Dermatology
Prosper, Texas, United States
Jordan Valley Dermatology Center
South Jordan, Utah, United States
Dermatology Research Institute
Calgary, Alberta, Canada
SimcoDerm Medical and Surgical Dermatology Center
Barrie, Ontario, Canada
Lynderm Research Inc.
Markham, Ontario, Canada
JRB Research Inc
Ottawa, Ontario, Canada
SKiN Centre for Dermatology
Peterborough, Ontario, Canada
Research Toronto
Toronto, Ontario, Canada
Siena Medical Research
Montreal, Quebec, Canada
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VY2024-02
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.