What side effects are associated with this type of intervention?

Common treatments for Cutaneous Lichen Planus include topical corticosteroids, tacrolimus, and JAK inhibitors like Ruxolitinib cream. Topical corticosteroids can cause skin thinning (atrophy), stretch marks, and increased susceptibility to infections. Tacrolimus, an alternative topical treatment, generally avoids skin atrophy but may cause burning or itching at the application site. Ruxolitinib cream, a JAK inhibitor, has been associated with side effects such as application site pruritus and acne. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment.

What prior FDA approvals exist?

There is limited information on prior FDA approvals specifically for the treatment of Cutaneous Lichen Planus, particularly with drugs similar to Ruxolitinib cream, a Janus kinase (JAK) inhibitor. However, treatments for related conditions such as atopic dermatitis have included JAK inhibitors like tofacitinib. Other treatments for lichen planus have typically involved corticosteroids, both topical and systemic, and immunosuppressive agents like tacrolimus. The study of Ruxolitinib cream represents an exploration into the efficacy and safety of JAK inhibitors for this specific condition.

What other types of research exist?

Promising novel alternatives to Ruxolitinib cream for Cutaneous Lichen Planus patients include Delgocitinib, a pan-Janus kinase inhibitor, which has shown efficacy and safety in treating chronic hand eczema. Additionally, Tofacitinib, another JAK inhibitor, has been investigated for its topical application in dermatological conditions like plaque psoriasis and may offer potential benefits for CLP.

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Janus Kinase (JAK) Inhibitor

Ruxolitinib Cream for Lichen Planus

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

Clinical diagnosis of LP with predominant cutaneous involvement.

Clinical diagnosis of LP with predominant cutaneous involvement

Must not have

Active ongoing inflammatory diseases of the skin other than LP that might confound the evaluation of LP lesions or compromise participant safety

Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, or Wiskott-Aldrich syndrome)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline; weeks 18, 20, 24, 28, and 32

Summary

This trial is testing the effectiveness and safety of Ruxolitinib cream for people with Cutaneous Lichen Planus. The cream is applied to the skin and works by blocking enzymes that cause inflammation. The study will compare the cream to another treatment over several months, followed by a period where all participants use the cream. Ruxolitinib cream has been previously tested and shown potent anti-inflammatory and antipruritic efficacy in atopic dermatitis.

Who is the study for?

This trial is for individuals with a skin condition called Cutaneous Lichen Planus, who experience itching and have moderate to severe symptoms. Participants must not be pregnant or planning pregnancy and should not have other skin infections or inflammatory conditions that could affect the study results.

What is being tested?

The study tests Ruxolitinib cream's effectiveness and safety against a placebo (Vehicle cream) in treating Cutaneous Lichen Planus. It starts with a 16-week double-blind phase where neither participants nor researchers know who gets which cream, followed by an open-label phase of another 16 weeks.

What are the potential side effects?

Possible side effects of Ruxolitinib cream may include irritation at the application site, increased risk of infection due to immune system effects, headaches, and potential allergic reactions. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

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

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My condition mainly affects my skin.

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My condition mainly affects my skin.

Exclusion Criteria

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

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I do not have skin conditions that could affect the study of my LP lesions.

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I have a condition that weakens my immune system.

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I have not taken antibiotics or antivirals for infections in the last 2 weeks.

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I haven't had skin infections like cold sores, shingles, or impetigo in the past week.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline; weeks 18, 20, 24, 28, and 32

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline; weeks 18, 20, 24, 28, and 32

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline; weeks 18, 20, 24, 28, and 32 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Percentage of Participants Achieving Investigator's Global Assessment-Treatment Success (IGA-TS) at Week 16

Secondary study objectives

Change From Baseline in the Skin Pain NRS Score at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period

Change From Baseline in the Skin Pain NRS Score at Each Scheduled Post-Baseline Visit in the Open-label Extension Period

Number of Participants With Any TEAE During the Open-label Extension Period

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Ruxolitinib creamExperimental Treatment2 Interventions

Ruxolitinib 1.5% cream BID for 16 weeks, followed by ruxolitinib cream BID 16-week open-label extension.

Group II: Vehicle CreamPlacebo Group1 Intervention

Vehicle cream BID for 16 weeks, followed by ruxolitinib 1.5% cream BID in a 16-week open-label extension.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ruxolitinib cream

2022

Completed Phase 3

~1850

Vehicle cream

2011

Completed Phase 3

~5360

0 / 6Eligibility 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

Cutaneous Lichen Planus is an inflammatory skin condition often treated with corticosteroids, immunosuppressants, and more recently, Janus kinase (JAK) inhibitors like Ruxolitinib. Corticosteroids work by reducing inflammation and suppressing the immune response, which helps alleviate symptoms. Immunosuppressants, such as cyclosporine, inhibit the activity of the immune system to prevent it from attacking the skin. JAK inhibitors, including Ruxolitinib, block the JAK-STAT signaling pathway, which is involved in the immune response and inflammation. By inhibiting this pathway, JAK inhibitors can reduce the inflammatory processes that contribute to the symptoms of Cutaneous Lichen Planus. This is particularly important for patients as it offers a targeted approach to managing the disease, potentially with fewer side effects compared to broader immunosuppressive therapies.

Drugs targeting the JAK/STAT pathway for the treatment of immune-mediated inflammatory skin diseases: protocol for a scoping review.