ACTIVE_NOT_RECRUITING

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

Conditions

Non-segmental Vitiligo NSV VYN201 Gel vitiligo

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-06-04

Study Completion:2026-01-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06493578

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Locations (Sites)

Cahaba Dermatology & Skin Health Center

Birmingham, Alabama, 35244

United States

Saguaro Dermatology

Phoenix, Arizona, 85008

United States

Center for Dermatology and Plastic Surgery/CCT Research

Scottsdale, Arizona, 85260

United States

Noble Clinical Research

Tucson, Arizona, 85704

United States

Clinical Trial Institute of Northwest Arkansas, LLC

Fayetteville, Arkansas, 72703

United States

Burke Pharmaceutical Research

Hot Springs, Arkansas, 71913

United States

California Dermatology & Clinical Research Institute

Encinitas, California, 92024

United States

First OC Dermatology Research, Inc

Fountain Valley, California, 92708

United States

Center for Dermatology Clinical Research, Inc

Fremont, California, 94538

United States

Marvel Clinical Research

Huntington Beach, California, 92647

United States

Northridge Clinical Trials

Northridge, California, 91325

United States

Palmtree Clinical Research, Inc.

Palm Springs, California, 92262

United States

Integrative Skin Science and Research

Sacramento, California, 95815

United States

Clarity Dermatology

Castle Rock, Colorado, 80109

United States

Colorado Medical Research Center

Denver, Colorado, 80210

United States

Skin Care Research

Boca Raton, Florida, 33486

United States

Driven Research LLC

Coral Gables, Florida, 33134

United States

Skin Care Research

Hollywood, Florida, 33021

United States

International Clinical Research - FL LLC

Sanford, Florida, 32771

United States

Metabolic Research Institute, Inc

West Palm Beach, Florida, 33401

United States

MetroMed Clinical Trials

Chicago, Illinois, 60614

United States

DS Research of Southern Indiana

Clarksville, Indiana, 47129

United States

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250

United States

DS Research of Kentucky

Louisville, Kentucky, 40241

United States

DelRicht Research at Audubon Dermatology

New Orleans, Louisiana, 70115

United States

Lawrence J. Green, MD LLC

Rockville, Maryland, 20850

United States

JDR Dermatology Research

Las Vegas, Nevada, 89148

United States

The Skin Center Dermatology Group

New City, New York, 10956

United States

Bobby Buka MD, PC

New York, New York, 10012

United States

Hickory Dermatology Research Center

Hickory, North Carolina, 28602

United States

The Skin Surgery Center for Clinical Research

Winston-Salem, North Carolina, 27103

United States

Clarity Dermatology

Canal Winchester, Ohio, 80109

United States

Central Sooner Research

Oklahoma City, Oklahoma, 73170

United States

Dermatology Associates of Plymouth Meeting

Plymouth Meeting, Pennsylvania, 19462

United States

Cumberland Skin Center for Clinical Research

Hermitage, Tennessee, 37076

United States

Arlington Research Center

Arlington, Texas, 76011

United States

Dermatology Treatment and Research Center

Dallas, Texas, 75230

United States

Newco 3A Research

El Paso, Texas, 79902

United States

Center for Clinical Studies, LTD.LLP

Houston, Texas, 77004

United States

Austin Insitute for Clinical Research

Pflugerville, Texas, 78660

United States

DelRicht Research at Lockhart Matter Dermatology

Prosper, Texas, 75078

United States

Jordan Valley Dermatology Center

South Jordan, Utah, 84095

United States

Collaborators and Investigators

Sponsor: Vyne Therapeutics Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-04

Study Completion Date2026-01-30

Study Record Updates

Study Start Date2024-06-04

Study Completion Date2026-01-30

Terms related to this study

Keywords Provided by Researchers

NSV
VYN201 Gel
vitiligo

Additional Relevant MeSH Terms

Non-segmental Vitiligo