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

ACTIVE_NOT_RECRUITINGPHASE2

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VYN201 Gel in Subjects With 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

NCT06493578•Vyne Therapeutics Inc.

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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
+8 more criteria

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.
+16 more criteria

Locations (49)

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

Key Dates

Start Date

June 4, 2024

Primary Completion Date

July 10, 2025

Completion Date

January 30, 2026

Last Updated

September 16, 2025

Enrollment

200

ESTIMATED participants

Conditions

Non-segmental Vitiligo

Interventions

VYN201 Gel

DRUG

Vehicle Gel

DRUG

A Phase IIb Dose-ranging Study to Assess the Efficacy and Safety of GIA632 in Participants With Non-segmental Vitiligo

NCT07431177

Non-segmental Vitiligo

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RECRUITINGPHASE4

Comparison of Needling and Microneedling Plus Phototherapy in Localized Vitiligo Patients

NCT06991972

VitiligoNon-segmental Vitiligo

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 16, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Phase IIb Dose-ranging Study to Assess the Efficacy and Safety of GIA632 in Participants With Non-segmental Vitiligo

Comparison of Needling and Microneedling Plus Phototherapy in Localized Vitiligo Patients

A Study to Evaluate the Efficacy and Safety of SYHX1901 Tablet in Non-segmental Vitiligo Patients

Cross-sectional Study to Characterize Real World Burden of Disease in Patients With Vitiligo in China

Topical Ruxolitinib Evaluation in Vitiligo Study 1 (TRuE-V1)

Topical Ruxolitinib Evaluation in Vitiligo Study 2 (TRuE-V2)