Not recruiting

Study on the Effects of Ruxolitinib Cream for Patients with Genital Vitiligo

Verified siteInvestigationalNo placebo

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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 vitiligo, a condition that causes patches of skin to lose their color. Specifically, the study is looking at nonsegmental vitiligo that affects the genital area. The treatment being tested is a cream containing ruxolitinib, which is applied directly to the skin. The purpose of the study is to see if this cream can help restore skin color in the affected areas.

Participants in the study will use the ruxolitinib cream for a period of time, and researchers will monitor any changes in skin color. The study will also track any side effects or changes in health that may occur during the treatment. The goal is to determine if the cream is safe and effective for treating vitiligo in the genital region.

Throughout the study, participants will have regular check-ups to assess the progress of the treatment. The study aims to find out if the cream can make the vitiligo patches less noticeable or even restore the skin to its normal color. This research could provide valuable insights into new treatment options for people with vitiligo.

The research process

The trial runs in 5 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, the participant must understand and sign an informed consent form (ICF).
Participants must agree to stop using any treatments for vitiligo, except for certain over-the-counter products and camouflage makeup, from the start of the study until the final safety follow-up visit.
Step 2
Medication administration
Participants will apply ruxolitinib cream to the affected genital area. The cream contains 1.5% of the active ingredient.
The cream is applied twice daily (BID), meaning once in the morning and once in the evening.
Step 3
Treatment duration
The treatment with ruxolitinib cream will continue for a period of 48 weeks.
Participants will be monitored throughout this period to assess the safety and effectiveness of the treatment.
Step 4
Evaluation and monitoring
The primary goal is to see if the vitiligo in the genital area becomes less noticeable or not noticeable at all by Week 48.
Secondary evaluations include monitoring for any side effects, changes in vital signs, and laboratory data.
The study will also assess changes in the affected skin area at Weeks 24 and 48, and the degree of color matching of the skin.
Step 5
Study completion
The study is expected to end by March 30, 2025.
Participants will have a final safety follow-up visit to ensure their well-being after the study concludes.

Who can join the trial?

11 criteria

Must be able to understand and willing to sign a form agreeing to participate in the study.
Must agree to stop using any treatments for **vitiligo** (a condition where the skin loses its color) from the start of the study until the end, except for certain over-the-counter products and makeup that can cover the skin.
Both men and women must agree to use birth control to prevent pregnancy during the study, unless the woman is unable to have children due to surgery or menopause (no periods for 12 months without another medical reason).
Must be 18 years or older at the time of signing the agreement form.
Must have a clinical diagnosis of **nonsegmental vitiligo** (a type of vitiligo) that affects the genital area. For women, this includes areas like the labia and perineum, and for men, the penis, scrotum, and perineum.
Must have at least 0.25% of the genital area affected by nonsegmental vitiligo.
Must have pigmented (colored) hair in the areas where the skin has lost color, if those areas have hair.
Must have at least one target spot in the genital area that is 0.1% of the body surface area and has pigmented hair in it.
Must have vitiligo on other parts of the body besides the genitals.
The total area of the body affected by vitiligo should not be more than 10% of the body surface area.
Must be willing to have photographs taken of the genital area for the study.

Who cannot join the trial?

8 criteria

Patients who do not have nonsegmental vitiligo with genital involvement cannot participate. Nonsegmental vitiligo is a condition where the skin loses its color in patches, and it affects both sides of the body.
Patients who are not within the specified age range for the study cannot participate. The age range includes children and adults.
Patients who are not willing to follow the study procedures or apply the cream as directed cannot participate.
Patients who have other skin conditions that might interfere with the study results cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have used certain medications or treatments that might affect the study results cannot participate.
Patients who have a history of allergic reactions to the study medication or similar products cannot participate.
Patients who are part of a vulnerable population, such as those unable to give informed consent, cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Centre Hospitalier Universitaire De Bordeaux
Bordeaux, France
Verified
Centre Hospitalier Universitaire De Nice
Nice, France
Verified
Hopital Henri Mondor - 1 rue Gustave Eiffel
Creteil, France

Trial locations

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Investigated drugs

Ruxolitinib Cream is a topical medication being studied for its ability to help with repigmentation in people with genital vitiligo. It is applied directly to the skin in the affected area. The study aims to see if using this cream can improve the color of the skin by reducing the appearance of white patches associated with vitiligo.

Ruxolitinib

What is already known about the treatment

Ruxolitinib Cream – This medication is applied topically as a cream and is currently being studied in clinical trials for its effectiveness in treating nonsegmental vitiligo with genital involvement. It is in the phase 2 stage of clinical trials, focusing on safety and efficacy. The main therapeutic indication is to promote repigmentation in areas affected by vitiligo. Ruxolitinib works by inhibiting certain enzymes known as Janus kinases (JAKs), which play a role in the immune response and inflammation. It is classified as a JAK inhibitor in pharmacology.

Investigated diseases

Nonsegmental Vitiligo with Genital Involvement – This is a skin condition characterized by the loss of skin color in patches, which occurs when the cells that produce melanin die or stop functioning. It can affect any part of the body, including the genital area, leading to noticeable white patches. The progression of the disease is unpredictable, with some people experiencing slow changes over many years, while others may see rapid changes. The affected areas may remain stable for a while, but new patches can appear over time. The condition is not contagious and does not cause physical discomfort, but it can have significant psychological and social impacts.