What side effects are associated with this type of intervention?

Common treatments for non-segmental vitiligo include topical corticosteroids, calcineurin inhibitors, and JAK inhibitors like Ruxolitinib 1.5% cream. The side effects of Ruxolitinib cream, a JAK inhibitor, may include application site reactions such as redness, itching, and irritation. Other potential side effects of JAK inhibitors can include acne, increased risk of infections, and, rarely, more serious systemic effects. It is important to discuss these potential side effects with a healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

As of now, there are no FDA-approved JAK inhibitors specifically for the treatment of non-segmental vitiligo. However, Ruxolitinib cream, a JAK inhibitor, is currently being studied for its efficacy and safety in treating this condition. Other treatments for non-segmental vitiligo typically include topical corticosteroids, calcineurin inhibitors, and phototherapy, but these are not JAK inhibitors. The ongoing research into JAK inhibitors like Ruxolitinib cream represents a promising new avenue for vitiligo treatment.

What other types of research exist?

Promising novel alternatives to Ruxolitinib 1.5% cream for non-segmental vitiligo include topical Janus kinase (JAK) inhibitors like Tofacitinib and Ritlecitinib, as well as emerging therapies such as Afamelanotide (a melanocortin 1 receptor agonist) and combination treatments involving phototherapy with new photosensitizing agents. These alternatives have shown potential in clinical trials for improving repigmentation and safety profiles.

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Janus Kinase (JAK) Inhibitor

Ruxolitinib Cream for Vitiligo

Phase 2

Waitlist Available

Research Sponsored by Incyte Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Vitiligo on areas of the body besides the genitals

At least 1 genital target lesion that is ≥ 0.1% BSA that has a pigmented hair within it

Must not have

An active sexually transmitted disease, sexually transmitted infection, or other skin disorder affecting the genital area (eg, scabies, fungal infection, molluscum)

Active or recurrent genital warts or herpes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 24 and 48

Awards & highlights

No Placebo-Only Group

Summary

This trial involves people with a type of vitiligo affecting their genital area using a special cream called ruxolitinib. The cream helps reduce skin inflammation to restore color to white patches. Ruxolitinib is known for its ability to help with repigmentation and is considered safe to use.

Who is the study for?

This trial is for individuals with non-segmental vitiligo affecting the genital area, covering no more than 10% of their body. Participants must have at least one target lesion in the genital area with pigmented hair and be willing to undergo genital photography. Pregnant or breastfeeding individuals, those considering pregnancy, or people with other skin conditions are excluded.

What is being tested?

The study tests Ruxolitinib Cream applied twice daily to depigmented areas including genitals for up to 48 weeks. The goal is to assess its safety and effectiveness in restoring pigment. It's an open-label trial where all participants know they're using this specific cream.

What are the potential side effects?

While not explicitly listed here, common side effects of topical treatments like Ruxolitinib Cream may include skin irritation, redness, itching at the application site, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have vitiligo on parts of my body other than the genitals.

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I have a genital lesion larger than 0.1% of my body surface area with a pigmented hair.

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Less than 10% of my body is affected by vitiligo.

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I have vitiligo covering more than 0.25% of my body, including the genital area.

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I have vitiligo that affects my genital area.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any active STDs or skin disorders affecting my genital area.

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I currently have or recently had genital warts or herpes.

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I have used treatments to lighten my skin.

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I have a type of vitiligo or a similar skin condition.

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My partner has an active cervical or anal pre-cancer condition.

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I've had 3 or more laser hair removal sessions on the area affected by vitiligo.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 24 and 48

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 24 and 48

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 and 48 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change from baseline in affected Body Surface Area BSA in the genital region

Number of Participants with Treatment Emergent Adverse Events (TEAEs)

Proportion of participants achieving Genital- Physician Global Vitiligo Assessment (PhGVA)

+3 more

Side effects data

From 2020 Phase 3 trial • 631 Patients • NCT03745638

Upper respiratory tract infection

Nasopharyngitis

Headache

Pneumonia

100%

80%

60%

40%

20%

Study treatment Arm

Ruxolitinib 0.75% Cream BID

Vehicle Cream BID

Ruxolitinib 1.5% Cream BID

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Ruxolitinib CreamExperimental Treatment1 Intervention

Participants with non-segmental vitiligo with genital involvement will receive ruxolitinib 1.5% cream BID for up to 48 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ruxolitinib Cream

2018

Completed Phase 3

~740

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

JAK inhibitors like Ruxolitinib 1.5% cream work by blocking the Janus kinase pathways involved in the immune response that leads to melanocyte destruction in non-segmental vitiligo. This inhibition reduces inflammation and halts the autoimmune attack on melanocytes, allowing for potential repigmentation. Understanding this mechanism is crucial for patients as it highlights the importance of targeting specific immune pathways to manage the condition effectively. Other treatments, such as corticosteroids and phototherapy, also aim to reduce inflammation and promote repigmentation but through different mechanisms, offering various approaches to disease management.