Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

An Open-Label, Phase 2, Safety, and Efficacy Study of Ruxolitinib Cream in Participants With Genital Vitiligo

This study is looking at a new cream called ruxolitinib in adults who have vitiligo affecting their genital area. Vitiligo is a condition where patches of skin lose their colour. The main goal of this study is to see how many people using the cream find that their vitiligo patches become much less noticeable or completely disappear after 48 weeks (almost a year). Researchers will also be checking for any side effects and how the cream affects the size of the vitiligo patches. This is a Phase 2 study, which means it’s still in the earlier stages, focusing on finding the right dose and further checking safety and how well the treatment works.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Incyte Corp.

Enrolment target

Start

12 Sep 2023

Nonsegmental vitiligo with genital involvement

What is this study about?

This study is investigating a new cream called ruxolitinib. It's designed for people who have vitiligo, specifically a type that affects the genital area. Vitiligo is a skin condition where patches of skin lose their natural colour, resulting in white or lighter spots. The cream aims to help these discoloured areas return to their normal skin tone.

The main purpose of this research is to understand how well this cream works and if it's safe to use. Researchers want to find out if applying the cream can make the vitiligo patches on the genitals much less noticeable or even make them disappear over a period of 48 weeks (nearly a year). They will be observing how many participants achieve this goal.

Beyond simply looking at how much the patches improve, the study will also carefully monitor participants for any side effects of the cream, check general health markers like blood pressure, and see how the overall area of vitiligo changes. This helps the medical community understand the full picture of the treatment's effects.

Key takeaways

This study is testing a new cream (ruxolitinib) for vitiligo on the genitals.
The goal is for white patches to become much less noticeable or disappear over 48 weeks.
It's for adults (18+) with nonsegmental vitiligo affecting their genital area.
Safety and side effects will be carefully watched throughout the study.
Participation involves regular clinic visits and using the cream as directed.

Who may be eligible?

This study is for adults aged 18 years and older; there's no upper age limit. Both men and women can take part in this research.

To be eligible, you must have a type of vitiligo called nonsegmental vitiligo, and it needs to be affecting your genital area. Your doctor or the study team will be able to confirm if your specific condition fits the study requirements.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a type of vitiligo called nonsegmental vitiligo?
Does your vitiligo affect your genital area?
Are you able to visit the clinic regularly for nearly a year?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be given ruxolitinib cream to apply. You will have regular visits to the clinic over a period of 48 weeks (almost a year). During these visits, the study team will check your skin, record how your vitiligo is changing, and monitor your general health. This will include checking for any side effects, taking measurements, and possibly collecting blood samples. You will also be asked questions about how the cream is affecting your skin and how you feel about the changes. There will be follow-up appointments after the main treatment period to ensure all information is gathered.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as access to a new treatment for vitiligo that might help improve your condition. However, there are also potential risks, including side effects from the cream or the need for frequent clinic visits. All possible side effects will be explained to you. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is vitiligo?

Vitiligo is a skin condition where patches of skin lose their natural colour, appearing as white or lighter areas.

What is ruxolitinib cream?

Ruxolitinib cream is the new treatment being tested in this study to see if it can help bring back colour to vitiligo patches.

How long will the study last?

The main treatment period for participants in this study will last for 48 weeks, which is almost a year.

What does 'genital involvement' mean?

It means the vitiligo patches are present on the genital (private) areas of the body.

Is this cream available to everyone now?

No, this cream is still being studied. If it proves safe and effective, it might become available in the future after further testing.