Ruxolitinib for Atopic Dermatitis

IR
Overseen ByIrma Richardson, MHA
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of ruxolitinib, a simple cream, for individuals with mild to moderate atopic dermatitis, a common skin condition that causes itchy and inflamed skin. Researchers aim to determine if using only this cream is easier and more effective than a complex skincare routine. Participants will either use the cream alone or receive additional lifestyle advice, such as recommendations for soaps and moisturizers. This trial may suit those with mild to moderate atopic dermatitis affecting two or more body areas. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective treatment benefits a broader range of patients.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but you cannot participate if you are changing systemic medications or treatments for atopic dermatitis.

What is the safety track record for Ruxolitinib?

Research has shown that the cream ruxolitinib, also known as Opzelura, is generally safe for treating atopic dermatitis. Studies have not identified any serious side effects from its use. Long-term users of ruxolitinib cream have tolerated it well and experienced good control of their condition. No major systemic side effects occurred, and only a few individuals reported mild reactions at the application site. However, it is important to avoid using ruxolitinib if a serious infection is present.12345

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for atopic dermatitis, which often include corticosteroids and calcineurin inhibitors, Ruxolitinib (Opzelura) offers a unique approach. It is a topical Janus kinase (JAK) inhibitor, targeting specific pathways in the immune system to reduce inflammation and itchiness. Researchers are excited because this mechanism directly addresses the underlying causes of atopic dermatitis rather than just masking symptoms. Additionally, the treatment plan includes an Eczema Action Plan (EAP) with lifestyle recommendations, which could enhance overall treatment effectiveness and patient quality of life.

What is the effectiveness track record for Ruxolitinib in treating atopic dermatitis?

Studies have shown that ruxolitinib cream can help treat atopic dermatitis, a type of eczema. In some research, more than half of the patients using a 1.5% ruxolitinib cream experienced a 75% improvement in their eczema symptoms. Another study found that 57% of patients using Opzelura, a brand of ruxolitinib cream, saw significant improvement, compared to only 11% who did not use it. Patients reported less skin pain just two weeks after starting treatment with ruxolitinib cream. In this trial, participants will either apply topical ruxolitinib (Opzelura) alone or in combination with a Complex Regimen, which includes an Eczema Action Plan with lifestyle recommendations. These findings suggest that ruxolitinib cream is a promising option for managing symptoms of atopic dermatitis.56789

Who Is on the Research Team?

SR

Steven R Feldman, MD, PhD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for people with atopic dermatitis (eczema) who are using topical treatments. Participants should be able to follow a treatment plan and not have other major health issues that would prevent participation.

Inclusion Criteria

I am at least 2 years old.
I have mild-to-moderate atopic dermatitis on two or more body areas.
I am a woman of childbearing age and I use contraception.
See 1 more

Exclusion Criteria

I do not currently have atopic dermatitis.
Patients who are pregnant
I have areas of skin with an active infection.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants apply topical ruxolitinib (Opzelura) twice daily to all affected areas until clear, then as needed. In the active comparator group, patients also follow an Eczema Action Plan with lifestyle recommendations.

8 weeks
Weekly assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of quality of life and eczema severity.

4 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Ruxolitinib

Trial Overview

The study compares two approaches: using the medication ruxolitinib cream alone versus ruxolitinib cream combined with an Eczema Action Plan, to see which helps patients stick to their treatment better.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: topical ruxolitinib (Opzelura)Experimental Treatment1 Intervention
Group II: topical ruxolitinib (Opzelura) and Complex RegimenActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials
1,432
Recruited
2,506,000+

Citations

Ruxolitinib Cream 1.5%: A Review in Mild to Moderate Atopic ...

Additionally, the efficacy of ruxolitinib cream 1.5% was demonstrated for a 75% improvement from baseline in the Eczema Area and Severity Index ...

Incyte Announces New Data for Ruxolitinib Cream (Opzelura ...

More than half (67.2%/51.5%) of patients treated with ruxolitinib cream (1.5% and 0.75% respectively) achieved EASI75 compared to those treated ...

Skin Results | Atopic Dermatitis

Results may vary -11: 57% achieved results compared to 11% not using OPZELURA In patients 12+: 54% achieved results compared to 15% not using OPZELURA.

Efficacy and safety of ruxolitinib cream for the treatment ...

Most patients treated with ruxolitinib cream achieved Skin Pain NRS2 by Week 2 (59.0% vs 34.1% [vehicle]; Supplementary Fig 8, available via ...

Exploring the Clinical Impact of Topical Ruxolitinib Cream ...

Eichenfield said the body surface area affected by AD decreased by nearly 58%. 37.3% of patients had mild AD, reflecting a significant ...

Side Effects | Atopic Dermatitis | OPZELURA® (ruxolitinib)

Learn about the safety and side effects of using OPZELURA®. See Important Safety Information and Full Prescribing Information, including Boxed Warning.

Efficacy, Safety, and Long-Term Disease Control of Ruxolitinib ...

Long-term intermittent use of ruxolitinib cream was well tolerated and provided disease control in adolescent patients with atopic dermatitis.

OPZELURA® (ruxolitinib) cream, for topical use

The safety and effectiveness of OPZELURA have not been established in pediatric patients younger than 2 years of age with atopic dermatitis. Nonsegmental ...

Therapeutic efficacy and safety of topical ruxolitinib in mild- ...

The topical use of ruxolitinib for atopic dermatitis showed acceptable safety profiles in the reviewed clinical trials. No serious adverse events were reported ...