A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VYN201 Gel in Subjects With Non… (NCT06493578) | Clinical Trial Compass
TerminatedPhase 2
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VYN201 Gel in Subjects With Non-segmental Vitiligo.
Stopped: Business Decision
United States205 participantsStarted 2024-06-04
Plain-language summary
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of VYN201 Gel in subjects with non-segmental vitiligo.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Has completed and signed an Informed Consent Form (ICF) prior to any study-related procedures.
✓. 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 not exceed 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 the study completion. Over-the-counter preparations deemed acceptable by the investigator are permitted.
✓. 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.
Exclusion criteria
✕. 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.).
✕. Concomitant dermatologic conditions or other medical condition(s) which may, in the opinion of the investigator, interfere with IMP application or study assessments.
✕. History of melanocyte transplantation procedure or depigmentation treatment \[e.g. Monobenzyl ether of hydroquinone (Monobenzone)\].
What they're measuring
1
To evaluate the efficacy of VYN201 compared to vehicle at Week 24 in subjects with NSV.
✕. 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.
✕. 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 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).