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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Bordeaux Bordeaux France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Nice Nice France
Hgzcfzm Hnhrl Mxegfw &chpcjf 1 rul Gmqccnk Egaxir Creteil France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
13.11.2023

Trial locations

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.

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.

Trial ID:
2023-503737-22-00
Protocol code:
INCB 18424-219
Trial Phase:
Therapeutic exploratory (Phase II)

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