Phase
Condition
Vitiligo
Treatment
Vehicle Gel
VYN201 Gel
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Has completed and signed an Informed Consent Form (ICF) prior to any study-relatedprocedures.
Able to understand and comply with study requirements.
Male or female aged 18 to 75 years, inclusive.
Clinical diagnosis of non-segmental vitiligo where the total affected BSA does notexceed 10%.
F-VASI score of ≥0.5 and ≤3.0.
T-VASI score of ≥3.0 and ≤10.0.
Agree to discontinue all agents used to treat vitiligo from Screening through thestudy completion. Over-the-counter preparations deemed acceptable by theinvestigator are permitted.
If receiving concomitant medication for any reason other than vitiligo, must be on astable regimen at Screening, and anticipating staying on a stable regimen throughthe study completion.
Female participants must:
Be of non-childbearing potential (i.e., surgically sterilized [hysterectomy,bilateral salpingectomy, bilateral oophorectomy, tubal ligation/occlusion atleast 6 weeks before the Screening]) or postmenopausal (where postmenopausal isdefined 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 tobecome pregnant and, if engaging in sexual intercourse with a male partner,must agree to use an acceptable method of contraception from signing the ICFuntil at least 1 month after the last dose of IMP. An acceptable method ofcontraception includes one of the following:
Hormonal contraception (for at least 3 months prior to Screening) incombination with a barrier method.
Intrauterine device (placement at least 3 months prior to Screening).
Diaphragm with spermicide.
Cervical cap with spermicide.
Condoms with spermicide.
Vasectomized partner (6 months minimum since vasectomy).
Male participants, if not biologically or surgically sterilized, must agree not todonate sperm and, if engaging in sexual intercourse, must agree to use a condom fromsigning the ICF until at least 1 month after the last dose of study drug. Ifengaging with a female partner who could become pregnant, the female partner mustadditionally use an acceptable method of contraception for this same period.
Exclusion
Exclusion Criteria:
Clinical diagnosis of other forms of vitiligo (e.g., segmental) or other hypo- orde-pigmentation skin diseases (e.g., piebaldism, leukoderma, Vogt-Koyanagi-Haradadisease, malignancy induced hypopigmentation, etc.).
Concomitant dermatologic conditions or other medical condition(s) which may, in theopinion of the investigator, interfere with IMP application or study assessments.
History of melanocyte transplantation procedure or depigmentation treatment [e.g.Monobenzyl ether of hydroquinone (Monobenzone)].
Visible test site skin injury, damage, or observations in or around the applicationsite which, in the opinion of the investigator, will interfere with studyassessments or increase participation risk.
Dyed hair in the treatment area that could interfere with any clinical assessments.
Significant facial hair or are unable to maintain very short cropped facial hair (<5mm) during course of the study.
Leukotrichia in >33% of vitiligo lesional surface of the face or the body.
History or presence of any clinically significant condition(s) which, in the opinionof the investigator, could interfere with the course of the study or expose theparticipant to undue risk by participating in this study, including, but not limitedto: 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).
Major surgery within 3 months of randomization or with planned major surgery duringtrial.
Current or recent history (<30 days before Screening and/or <45 days beforerandomization) of a clinically meaningful bacterial, fungal, parasitic, ormycobacterial infection.
Any known or suspected premalignant or malignant disease within 5 years prior toScreening (excluding successfully treated basal or squamous cell carcinomas, actinickeratoses, melanoma in situ, cervical dysplasias, cervical cancer).
Systemic biologic or immune-modulating treatment within 12 weeks prior to Screeningand through study completion or topical treatment in the vitiligo areas within 2weeks prior to Screening and through study completion.
Received any investigational therapy, device or procedure within 30 days or 5half-lives (whichever is longer) prior to Screening. Investigational biologicsshould be discussed with the sponsor to determine if a longer period ofdiscontinuation is required.
Relevant (in the investigator opinion) ultraviolet light exposure includingphototherapy within 8 weeks prior to Screening.
Use of any other prior and concomitant therapy not listed above that, in the opinionof the investigator, may interfere with the evaluation of study outcomes, includingdrugs that cause photosensitivity or skin pigmentation (e.g. antibiotics such astetracyclines, antifungals). These medications should be discontinued within 4 weeksof randomization.
Known or suspected history of alcohol or drug abuse within 12 months of Screening orin the opinion of the investigator, will interfere with the subject's ability tocomply with the administration schedule and study assessments (alcohol abuse isdefined as regular consumption of >10 standard units of alcohol per week).
Subjects who are pregnant or breastfeeding.
Clinically significant abnormal laboratory values at Screening:
Neutrophils < lower limit of normal.
Hemoglobin < 10 g/dL.
Platelets < 100 × 109/L.
Alanine transaminase (ALT) or aspartate transaminase (AST) ≥ 2.0 × upper limitof normal.
Estimated creatinine clearance < 30 mL/min or renal disease requiring dialysisas determined by Cockcroft-Gault.
Positive serology tests for Hepatitis B surface antigen (HBsAg), hepatitis Cvirus antibody (anti-HCV), or human immunodeficiency virus (HIV)-1 and HIV-2antibody.
Subjects who received a live vaccine within 4 weeks prior to Screening.
Subjects with known allergy or reaction to any component of the study formulation.
Study Design
Connect with a study center
Dermatology Research Institute
Calgary, Alberta T2J 7E1
CanadaActive - Recruiting
SimcoDerm Medical and Surgical Dermatology Center
Barrie, Ontario L4M 7G1
CanadaActive - Recruiting
Lynderm Research Inc.
Markham, Ontario L3P 1X3
CanadaActive - Recruiting
JRB Research Inc
Ottawa, Ontario K1KL2
CanadaActive - Recruiting
SKiN Centre for Dermatology
Peterborough, Ontario K9J 5K2
CanadaActive - Recruiting
Research Toronto
Toronto, Ontario M4W 2N4
CanadaActive - Recruiting
Siena Medical Research
Montréal, Quebec H3Z 2S6
CanadaActive - Recruiting
Cahaba Dermatology & Skin Health Center
Birmingham, Alabama 35244
United StatesActive - Recruiting
Saguaro Dermatology
Phoenix, Arizona 85008
United StatesActive - Recruiting
Center for Dermatology and Plastic Surgery/CCT Research
Scottsdale, Arizona 85260
United StatesActive - Recruiting
Noble Clinical Research
Tucson, Arizona 85704
United StatesActive - Recruiting
Clinical Trial Institute of Northwest Arkansas, LLC
Fayetteville, Arkansas 72703
United StatesActive - Recruiting
Burke Pharmaceutical Research
Hot Springs, Arkansas 71913
United StatesActive - Recruiting
California Dermatology & Clinical Research Institute
Encinitas, California 92024
United StatesActive - Recruiting
First OC Dermatology Research, Inc
Fountain Valley, California 92708
United StatesActive - Recruiting
Center for Dermatology Clinical Research, Inc
Fremont, California 94538
United StatesActive - Recruiting
Marvel Clinical Research
Huntington Beach, California 92647
United StatesActive - Recruiting
Northridge Clinical Trials
Northridge, California 91325
United StatesActive - Recruiting
Palmtree Clinical Research, Inc.
Palm Springs, California 92262
United StatesActive - Recruiting
Integrative Skin Science and Research
Sacramento, California 95815
United StatesActive - Recruiting
Colorado Medical Research Center
Denver, Colorado 80210
United StatesActive - Recruiting
Skin Care Research
Boca Raton, Florida 33486
United StatesActive - Recruiting
Driven Research LLC
Coral Gables, Florida 33134
United StatesActive - Recruiting
Skin Care Research
Hollywood, Florida 33021
United StatesActive - Recruiting
International Clinical Research - FL LLC
Sanford, Florida 32771
United StatesActive - Recruiting
Metabolic Research Institute, Inc
West Palm Beach, Florida 33401
United StatesActive - Recruiting
MetroMed Clinical Trials
Chicago, Illinois 60614
United StatesActive - Recruiting
DS Research of Southern Indiana
Clarksville, Indiana 47129
United StatesActive - Recruiting
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana 46250
United StatesActive - Recruiting
DS Research of Kentucky
Louisville, Kentucky 40241
United StatesActive - Recruiting
DelRicht Research at Audubon Dermatology
New Orleans, Louisiana 70115
United StatesActive - Recruiting
Lawrence J. Green, MD LLC
Rockville, Maryland 20850
United StatesActive - Recruiting
JDR Dermatology Research
Las Vegas, Nevada 89148
United StatesActive - Recruiting
The Skin Center Dermatology Group
New City, New York 10956
United StatesActive - Recruiting
Bobby Buka MD, PC
New York, New York 10012
United StatesActive - Recruiting
Hickory Dermatology Research Center
Hickory, North Carolina 28602
United StatesActive - Recruiting
The Skin Surgery Center for Clinical Research
Winston-Salem, North Carolina 27103
United StatesActive - Recruiting
DOCS Dermatology Research - Canal Winchester
Canal Winchester, Ohio 43110
United StatesActive - Recruiting
Clarity Dermatology
Castle Rock, Ohio 80109
United StatesActive - Recruiting
Central Sooner Research
Oklahoma City, Oklahoma 73170
United StatesActive - Recruiting
Dermatology Associates of Plymouth Meeting
Plymouth Meeting, Pennsylvania 19462
United StatesActive - Recruiting
Cumberland Skin Center for Clinical Research
Hermitage, Tennessee 37076
United StatesActive - Recruiting
Dermatology Treatment and Research Center
Dallas, Texas 75230
United StatesActive - Recruiting
Newco 3A Research
El Paso, Texas 79902
United StatesActive - Recruiting
Center for Clinical Studies, LTD.LLP
Houston, Texas 77004
United StatesActive - Recruiting
Austin Insitute for Clinical Research
Pflugerville, Texas 78660
United StatesActive - Recruiting
DelRicht Research at Lockhart Matter Dermatology
Prosper, Texas 75078
United StatesActive - Recruiting
Jordan Valley Dermatology Center
South Jordan, Utah 84095
United StatesActive - Recruiting
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