200 Participants Needed

VYN201 Gel for Vitiligo

Recruiting at 49 trial locations
IS
Overseen ByIain Stuart, PhD
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Do I need to stop taking my current medications for the trial?

You will need to stop taking any medications used to treat vitiligo during the trial. However, if you are taking other medications for different conditions, you can continue them as long as your regimen is stable from the start of the trial to its completion.

What safety data is available for VYN201 Gel (repibresib) in treating vitiligo?

The provided research does not contain specific safety data for VYN201 Gel (repibresib) in the treatment of vitiligo. The studies focus on other treatments and their safety profiles, such as ruxolitinib cream, excimer light, targeted UVB, and other drugs associated with vitiligo. Therefore, no direct safety data for VYN201 Gel is available in the provided research.12345

Is VYN201 Gel a promising drug for vitiligo?

The information provided does not directly mention VYN201 Gel or its effectiveness for vitiligo. Therefore, we cannot determine if VYN201 Gel is a promising drug for vitiligo based on the given research articles.26789

What data supports the idea that VYN201 Gel for Vitiligo is an effective treatment?

The available research does not provide any data on the effectiveness of VYN201 Gel for Vitiligo. The studies listed focus on other treatments and conditions, such as eye diseases and vision-related therapies, but do not mention VYN201 Gel or its use for Vitiligo.1011121314

Are You a Good Fit for This Trial?

This trial is for individuals with non-segmental vitiligo, a condition where skin loses its pigment. Details about who can join or reasons why someone might not be eligible are not provided.

Inclusion Criteria

I have vitiligo affecting less than 10% of my body.
Has completed and signed an Informed Consent Form (ICF) prior to any study-related procedures
I understand and can follow the study's requirements.
See 6 more

Exclusion Criteria

I don't have skin injuries near the test site that could affect the study.
My hair in the treatment area is not dyed.
I have had treatments to change the color of my skin.
See 17 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive VYN201 Gel or placebo once daily for 24 weeks in a double-blind, vehicle-controlled period

24 weeks

Treatment Extension

Participants continue treatment with VYN201 Gel for an additional 28 weeks, maintaining the blind

28 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • VYN201 Gel
Trial Overview The study is testing the effectiveness and safety of VYN201 Gel compared to a Vehicle Gel (a gel without the active drug) in treating non-segmental vitiligo. It also looks at how the body processes the gel.
How Is the Trial Designed?
4Treatment groups
Active Control
Placebo Group
Group I: Low dose VYN201 (1.0%)Active Control1 Intervention
Group II: Mid dose VYN201 (2.0%)Active Control1 Intervention
Group III: High dose VYN201 (3.0%)Active Control1 Intervention
Group IV: VehiclePlacebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vyne Therapeutics Inc.

Lead Sponsor

Trials
37
Recruited
9,700+

Published Research Related to This Trial

In a study of 12 patients receiving subretinal voretigene neparvovec (VN) gene therapy for retinal disease, 39% of eyes developed vitritis, an inflammation of the eye, which typically resolved within 89 days with appropriate treatment.
Despite the occurrence of inflammation, it did not negatively impact visual outcomes, although monitoring and treatment are essential to prevent potential long-term damage to the retina.
Inflammation after Voretigene Neparvovec Administration in Patients with RPE65-Related Retinal Dystrophy.Kessel, L., Christensen, UC., Klemp, K.[2022]
Photodynamic therapy using verteporfin effectively occluded bilateral corneal neovascularization and significantly reduced lipid keratopathy in a 36-year-old patient, leading to improved visual acuity from 20/80 and 20/100 to 20/30 in both eyes over a 4-year follow-up period.
The treatment was safe, with no observed recurrences or complications during the follow-up, suggesting that verteporfin laser therapy is a reliable option for managing corneal neovascularization.
Resolution of bilateral corneal neovascularization and lipid keratopathy after photodynamic therapy with verteporfin.Al-Abdullah, AA., Al-Assiri, A.[2018]
Verteporfin therapy leads to short-lived skin photosensitivity, peaking at 1.5 hours post-treatment and decreasing rapidly, with a duration of 2 to 6.7 days depending on the dose.
In clinical trials, only 2.2% of patients experienced photosensitivity reactions, indicating a low incidence of adverse effects, which could be minimized with proper skin protection following treatment.
Duration of skin photosensitivity and incidence of photosensitivity reactions after administration of verteporfin.Houle, JM., Strong, HA.[2019]

Citations

Inflammation after Voretigene Neparvovec Administration in Patients with RPE65-Related Retinal Dystrophy. [2022]
Resolution of bilateral corneal neovascularization and lipid keratopathy after photodynamic therapy with verteporfin. [2018]
Duration of skin photosensitivity and incidence of photosensitivity reactions after administration of verteporfin. [2019]
Durability of Voretigene Neparvovec for Biallelic RPE65-Mediated Inherited Retinal Disease: Phase 3 Results at 3 and 4 Years. [2021]
Ranibizumab: in macular oedema following retinal vein occlusion. [2021]
Vitiligo of the Face in a Patient Treated With Vemurafenib for Metastatic Melanoma. [2018]
Baseline Levels of Circulating Inflammatory Biomarkers Stratify Patients with Vitiligo Who Significantly Repigment after Treatment with Ruxolitinib Cream. [2023]
Is targeted UVB as effective as excimer light phototherapy in treatment of vitiligo? [2021]
Drug-induced vitiligo: a case/non-case study in Vigibase® , the WHO pharmacovigilance database. [2021]
Apremilast and narrowband ultraviolet B combination therapy suppresses Th17 axis and promotes melanogenesis in vitiligo skin: a randomized, split-body, pilot study in skin types IV-VI. [2023]
Tofacitinib combined with melanocyte protector α-MSH to treat vitiligo through dextran based hydrogel microneedles. [2023]
12.United Statespubmed.ncbi.nlm.nih.gov
Heterologous Type I Collagen as an Add-on Therapy to Narrowband Ultraviolet B for the Treatment of Vitiligo: A Pilot Study. [2022]
13.United Statespubmed.ncbi.nlm.nih.gov
A Potential Alternative Treatment for Vitiligo: An Observational Study on Tacrolimus 0.3% Lotion. [2022]
14.United Statespubmed.ncbi.nlm.nih.gov
A pilot study to determine the safety and efficacy of monochromatic excimer light in the treatment of vitiligo. [2022]
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