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Study on MK-6194 for Treating Adults with Non-Segmental Vitiligo

Verified siteInvestigational

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a skin condition called non-segmental vitiligo. This condition causes patches of skin to lose their color. The study is testing a new treatment called MK-6194, which is given as a solution for injection. The purpose of the study is to evaluate how effective and safe MK-6194 is for treating non-segmental vitiligo.

Participants in the study will receive either the MK-6194 treatment or a placebo. The study will last for about a year, during which participants will have regular check-ups to monitor their progress. The main focus will be on changes in the skin condition, particularly on the face, over a 24-week period. The study will also keep track of any side effects experienced by participants.

By the end of the study, researchers hope to gather enough information to understand how well MK-6194 works in improving the skin condition and how safe it is for patients. This information could help in developing new treatments for people with non-segmental vitiligo in the future.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be informed about the purpose and procedures of the clinical trial. You will be asked to provide informed consent, confirming your understanding and willingness to participate.
Step 2
Initial assessment
An initial assessment will be conducted to confirm your eligibility. This includes verifying your diagnosis of non-segmental vitiligo and ensuring that your condition meets the study criteria, such as having a certain level of depigmentation.
Step 3
Randomization
You will be randomly assigned to receive either the study medication MK-6194 or a placebo. This process is double-blind, meaning neither you nor the study team will know which treatment you are receiving.
Step 4
Treatment administration
The treatment involves receiving a solution for injection. The frequency and dosage will be determined by the study protocol, and you will be informed about the schedule and duration of the treatment.
Step 5
Regular follow-up visits
You will attend regular follow-up visits to monitor your progress and any side effects. These visits will include assessments of your vitiligo using the Facial Vitiligo Area Scoring Index (F-VASI) and other relevant measures.
Step 6
Evaluation at week 24
At week 24, a detailed evaluation will be conducted to assess the change in your vitiligo condition. This will include measuring the change from baseline in the F-VASI and other indices.
Step 7
Completion of study participation
Upon completion of the study, you will have a final visit to discuss your overall experience and any remaining questions. The study team will provide information on the next steps and any follow-up care if needed.

Who can join the trial?

7 criteria

Must have a clinical diagnosis of non-segmental vitiligo.
Must have had non-segmental vitiligo for at least 6 months.
Must have depigmentation contributing to F-VASI (Facial Vitiligo Area Scoring Index) of 0.3 or more at the start of the study.
Must have depigmented facial body surface area of 0.3% or more at the start of the study.
Must have a T-VASI (Total Vitiligo Area Scoring Index) of 4 or more at the start of the study.
Must have a total body vitiligo area of 4% or more at the start of the study, not including hands and feet.
Must be between 18 and 75 years old at the time of giving consent to participate.

Who cannot join the trial?

7 criteria

Patients with any other skin conditions that might interfere with the study results.
Patients who have used any treatments for vitiligo within a certain period before the study starts.
Patients with a history of severe allergic reactions to any of the ingredients in the study medication.
Patients who are currently participating in another clinical trial.
Patients with any serious medical conditions that could affect their safety during the study.
Pregnant or breastfeeding women.
Patients who are unable to follow the study procedures or attend the required visits.

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Verified sites

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Verified
Amsterdam UMC
Amsterdam, The Netherlands
Responsive
Katholieke Universiteit te Leuven
Leuven, Belgium
Responsive
Universitair Ziekenhuis Gent
Gent, Belgium

Trial locations

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Investigated drugs

MK-6194 is a medication being studied for its potential to help people with non-segmental vitiligo, a condition where patches of skin lose their color. The main goal of this trial is to see if MK-6194 can improve the appearance of the skin by reducing the size of these patches on the face over a period of 24 weeks. Researchers are also looking at how safe and well-tolerated the medication is for the participants. This means they are checking for any side effects or issues that might arise from taking the medication. The study is designed to compare the effects of MK-6194 with a placebo, but the focus here is on understanding how MK-6194 might help improve skin color in people with vitiligo.

Mk-6194

What is already known about the treatment

MK-6194 – MK-6194 is administered in a form that is suitable for clinical trials, typically as an oral or topical medication, although the exact form is not specified in the provided data. It is currently being studied in a Phase 2a clinical trial to assess its effectiveness and safety for treating non-segmental vitiligo, a condition characterized by loss of skin color in patches. The main goal of the trial is to see how well MK-6194 can improve the appearance of facial vitiligo by measuring changes in the Facial Vitiligo Area Scoring Index (F-VASI) over 24 weeks. The medication works at the molecular level by potentially influencing pathways involved in skin pigmentation, although specific details of its mechanism are not provided. MK-6194 falls under the pharmacological classification of treatments for skin disorders, specifically targeting conditions like vitiligo.

Investigated diseases

Non-segmental vitiligo – Non-segmental vitiligo is a skin condition characterized by the loss of pigment, resulting in white patches on the skin. It occurs when the cells responsible for skin color, called melanocytes, are destroyed. This type of vitiligo often appears symmetrically on both sides of the body and can affect any part of the skin. The progression of non-segmental vitiligo is unpredictable, with periods of stability and times when new patches appear. The condition can spread over time, affecting larger areas of the skin. It is not associated with physical discomfort but can have psychological and social impacts due to its visible nature.