What is the mechanism of action of this treatment?

The most common treatments for Lichen Sclerosus include potent topical corticosteroids like clobetasol propionate and JAK inhibitors like Ruxolitinib cream. Clobetasol propionate works by reducing inflammation and suppressing the immune response, which helps alleviate symptoms and promote healing of the affected skin. Ruxolitinib cream, a JAK inhibitor, blocks the JAK-STAT signaling pathway, which is involved in the inflammatory process. By inhibiting this pathway, Ruxolitinib reduces inflammation and immune activity in the skin. These treatments are crucial for Lichen Sclerosus patients as they help manage symptoms, prevent disease progression, and improve the quality of life.

What side effects are associated with this type of intervention?

Common treatments for Lichen Sclerosus include topical corticosteroids, which can cause skin thinning, irritation, and increased risk of infection with prolonged use. For treatments similar to Ruxolitinib cream, which is a Janus kinase (JAK) inhibitor, side effects may include application site reactions such as redness, itching, and burning. Systemic side effects of JAK inhibitors, although less common with topical application, can include increased risk of infections, changes in blood counts, and potential liver enzyme abnormalities. It is important to discuss these potential side effects with a healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

There is no specific mention of prior FDA approvals for the treatment of Lichen Sclerosus in the provided context. However, Ruxolitinib cream, a Janus kinase (JAK) inhibitor, is being studied for its efficacy and safety in treating this condition. JAK inhibitors are a class of drugs that have shown promise in treating various inflammatory and autoimmune conditions, but their use in Lichen Sclerosus is still under investigation.

What other types of research exist?

Promising novel alternatives to Ruxolitinib cream for Lichen Sclerosus patients include Tacrolimus, a nonsteroidal topical calcineurin inhibitor, and Delgocitinib, a pan-Janus kinase inhibitor. Both have shown efficacy in treating other dermatological conditions and could be considered as potential treatments.

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Janus Kinase (JAK) Inhibitor

Ruxolitinib Cream for Lichen Sclerosus

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from week 12 to week 24 plus 30 days

Summary

This trial is testing a cream called Ruxolitinib on people with Lichen Sclerosus, a chronic skin condition. The cream works by blocking enzymes that cause inflammation and immune responses. The study will last for several months. Ruxolitinib cream has been tested in various conditions such as atopic dermatitis and vitiligo, showing anti-inflammatory and repigmentation effects.

Who is the study for?

This trial is for individuals with Lichen Sclerosus, specifically those who have a confirmed diagnosis in the anogenital area and are experiencing itching. Participants must not be pregnant or planning pregnancy and should not have other infections or conditions that could explain their symptoms.

What is being tested?

The study is testing Ruxolitinib cream's effectiveness and safety against a placebo (vehicle cream) over a 12-week period, followed by another 12 weeks where everyone receives Ruxolitinib to further assess its effects.

What are the potential side effects?

While specific side effects of Ruxolitinib cream are not listed here, similar medications can cause skin irritation, headaches, dizziness, and increased risk of infection. The trial will monitor participants closely for any adverse reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from week 12 to week 24 plus 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from week 12 to week 24 plus 30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and from week 12 to week 24 plus 30 days 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 With ITCH4 at Week 12

Secondary study objectives

Change From Baseline in the Clinical Lichen Sclerosus Score (CLISSCO) at Week 12

Change From Baseline in the Skin Pain NRS Score at Week 12

Number of Participants With Any Clinically Meaningful Changes Over Time in Clinical Laboratory Test Results During the Double-blind, Vehicle-controlled Period

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Ruxolitinib creamExperimental Treatment2 Interventions

Ruxolitinib 1.5% cream BID for 12 weeks followed by ruxolitinb 1.5% cream BID (or QD) for 12-weeks in an open-label extension.

Group II: Vehicle CreamPlacebo Group1 Intervention

Vehicle cream BID for 12 weeks followed by ruxolitinb 1.5% cream BID (or QD) for 12-weeks in an 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

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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

The most common treatments for Lichen Sclerosus include potent topical corticosteroids like clobetasol propionate and JAK inhibitors like Ruxolitinib cream. Clobetasol propionate works by reducing inflammation and suppressing the immune response, which helps alleviate symptoms and promote healing of the affected skin. Ruxolitinib cream, a JAK inhibitor, blocks the JAK-STAT signaling pathway, which is involved in the inflammatory process. By inhibiting this pathway, Ruxolitinib reduces inflammation and immune activity in the skin. These treatments are crucial for Lichen Sclerosus patients as they help manage symptoms, prevent disease progression, and improve the quality of life.

Drugs targeting the JAK/STAT pathway for the treatment of immune-mediated inflammatory skin diseases: protocol for a scoping review.Lichen sclerosus. Therapy with clobetasol propionate.