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New eczema cream shows promise in large trial

NCT ID NCT06238817

Symptom relief Sponsor: Incyte Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a cream containing ruxolitinib on 241 adults with moderate atopic dermatitis (eczema) who had not gotten better with standard steroid creams. The goal was to see if the cream could improve skin clearing and reduce itching. The trial is now complete, and results will show how well the cream worked compared to a placebo cream.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ruxolitinib cream
What this could lead to
If successful, this could offer a new topical treatment option for adults with moderate eczema who haven't responded well to standard creams.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. The cream may not work for everyone, and side effects like skin irritation or infection are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

241 people

The number who actually took part.

Started

Apr 2024

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adults aged ≥ 18 years at screening (Note: Legal adult age for Korea is ≥ 19 years). * Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria. * AD duration of at least 2 years. * IGA score of 3 at screening and Day 1. * EASI score \> 7 at screening and Day 1. * Itch NRS score ≥ 4 at Day 1, defined as the average of the 7 days directly before Day 1, with Itch NRS values available for at least 4 of the 7 days. * %BSA (excluding the scalp) with AD involvement of at least 10% and up to 20% at screening and Day 1. * DLQI score \> 10 at screening and Day 1. * Documented recent history (within 12 months before the screening visit) of inadequate response, intolerance, or contraindication to TCSs and TCIs. * Agree to discontinue all agents used to treat AD from screening through the final follow up visit, except as outlined in the protocol. * Willingness to avoid pregnancy or fathering children based on the criteria as outlined in the protocol. Exclusion Criteria: * Unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to Day 1. * Concurrent conditions and history of other diseases as follows: * Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, Wiskott-Aldrich syndrome). * Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before Day 1. * Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex, herpes zoster, chickenpox) within 1 week before Day 1. * Any other concomitant skin disorder (eg, generalized erythroderma, such as Netherton syndrome), pigmentation, or extensive scarring that, in the opinion of the investigator, may interfere with the evaluation of AD lesions or compromise participant safety. * Presence of AD lesions only on the hands or feet without prior history of involvement of other classic areas of involvement such as the face or the flexural folds. * Other types of eczema within the 6 months prior to screening. Note: Seborrheic dermatitis on the scalp is allowed, as the scalp will not be treated with study cream. * Current or history of hepatitis B or C virus infection. * Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including administration of study cream and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data. * Any of the following clinical laboratory test results at screening: * Hemoglobin \< 10 g/dL. * Liver function tests: * AST or ALT ≥ 2 × ULN. * Alkaline phosphatase \> 1.5 × ULN. * Bilirubin \> 1.5 × ULN (isolated bilirubin \> 1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin \< 35%) with the exception of Gilbert's disease. * Estimated glomerular filtration rate \< 30 mL/min/1.73 m2 (using the Chronic Kidney Disease Epidemiology Collaboration equation). * Positive serology test results for HIV antibody. * Any other clinically significant laboratory result that, in the opinion of the investigator, poses a significant risk to the participant. * Use of any of the following treatments within the indicated washout period before Day 1: * 5 half-lives or 12 weeks, whichever is longer: biologic agents. For biologic agents with washout periods longer than 12 weeks (eg, rituximab), consult the medical monitor. * 4 weeks: systemic corticosteroids or adrenocorticotropic hormone analogs, cyclosporine, methotrexate, azathioprine, or other systemic immunosuppressive (eg, JAK inhibitors) or immunomodulating agents (eg, mycophenolate or tacrolimus). * 2 weeks or 5 half-lives, whichever is longer - strong systemic CYP3A4 inhibitors. * 2 weeks: immunizations with live-attenuated vaccines; sedating antihistamines unless on a long-term stable regimen (nonsedating antihistamines are permitted). Note: COVID-19 vaccination is allowed. • 1 week: use of other topical treatments for AD, other than bland emollients (eg, Aveeno creams, ointments, sprays, soap substitutes), such as antipruritics (eg, doxepin cream), corticosteroids, calcineurin inhibitors, PDE4 inhibitors, coal tar (shampoo), antibiotics, or antibacterial cleansing body wash/soap. Note: Diluted sodium hypochlorite "bleach" baths are allowed as long as they do not exceed 2 baths per week and their frequency remains the same throughout the study. * History of treatment failure with any systemic or topical JAK inhibitor (eg, ruxolitinib, tofacitinib, baricitinib, abrocitinib, upadacitinib) for AD or any other inflammatory condition. * Ultraviolet light therapy or prolonged exposure to natural or artificial sources of UV radiation (eg, sunlight or tanning booth) within 2 weeks prior to the baseline visit and/or intention to have such exposure during the study that is thought by the investigator to potentially impact the participant's AD. * Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before baseline with another investigational medication or current enrollment in another investigational drug protocol. * In the opinion of the investigator, are unable or unlikely to comply with the administration schedule, study evaluations, and procedures (eg, eDiary compliance). Other protocol-defined Inclusion/Exclusion Criteria may apply.

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Conditions

The condition(s) this trial relates to.

atopic eczema Eczema Pruritus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atopic dermatitis

Contacts and locations

Locations

  • Ambulatory For Specialized Medical Help - Skin and Venereal Diseases

    Sofia, 01407, Bulgaria

  • Amphia Ziekenhuis, Molengracht

    Breda, 04818, Netherlands

  • Arlington Dermatology

    Rolling Meadows, Illinois, 60008, United States

  • Australian Clinical Research Network

    Maroubra, New South Wales, 02035, Australia

  • Azienda Ospedaliera Universitaria Federico Ii

    Naples, 80131, Italy

  • Best Skin Research

    Camp Hill, Pennsylvania, 17011, United States

  • Bravis Ziekenhuis

    Bergen op Zoom, 4624 VT, Netherlands

  • Ceim Hospital Universitari Germans Trias I Pujol

    Badalona, 08916, Spain

  • Center For Clinical Studies Webster

    Houston, Texas, 77004, United States

  • Center For Dermatology Cosmetic and Laser Surgery

    Fremont, California, 94538, United States

  • Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu

    Nantes, 44093, France

  • Centre de Recherche Dermatologique Du Quebec Metropolitain

    Québec, Quebec, G1V 4X7, Canada

  • Centrum Badan Klinicznych Pi-House Sp. Z O.O.

    Gdansk, 80-546, Poland

  • Centrum Medyczne All-Med

    Krakow, 30-033, Poland

  • Centrum Medyczne Evimed

    Warsaw, 02-625, Poland

  • Centrum Medyczne Pratia Katowice

    Katowice, 40-081, Poland

  • Chu de Rouen - Hospital Charles Nicolle

    Rouen, 76000, France

  • Clinexpert Kft.

    Budapest, 01033, Hungary

  • Clinical Trials Sa

    Campbelltown, South Australia, 05074, Australia

  • Cliniques Universitaires Ucl Saint-Luc

    Brussels, 01200, Belgium

  • Dcc 'Alexandrovska', Eood

    Sofia, 01431, Bulgaria

  • Debreceni Egyetem Klinikai Kozpon Belgyogy Klinika

    Debrecen, 04032, Hungary

  • Dermatologie Handelskaai

    Kortrijk, 08500, Belgium

  • Dermatologie Potsdam Mvz Gmbh

    Potsdam, 14467, Germany

  • Dermatology & Skin Care Clinic

    Buochs, 06374, Switzerland

  • Dermatology Research Institute Inc.

    Calgary, Alberta, T2J 7E1, Canada

  • Dermmedica Sp. Z O.O.

    Wroclaw, 51-503, Poland

  • Diagnostic Consultative Center Xxviii

    Sofia, 01592, Bulgaria

  • Dr. Chih-Ho Hong Medical Inc.

    Surrey, British Columbia, V3R 6A7, Canada

  • Dr. Irina Turchin Pc Inc.

    Fredericton, New Brunswick, E3B 1G9, Canada

  • Encore Medical Research, Llc Hollywood

    Hollywood, Florida, 33021, United States

  • Entrust Clinical Research

    Miami, Florida, 33176, United States

  • Etg Lublin

    Lublin, 20-412, Poland

  • Fachklinik Bad Bentheim Dermatologie

    Bad Bentheim, 48455, Germany

  • First Oc Dermatology

    Fountain Valley, California, 92708, United States

  • Fondazione Irccs Ca Granda Ospedale Maggiore

    Milan, 20122, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli Irccs

    Rome, 00168, Italy

  • Ghicl - Hôpital Saint-Vincent de Paul

    Lille, 59020, France

  • Grand Hopital de Charleroi

    Gilly, 06060, Belgium

  • Guys Hospital

    London, SE1 9RT, United Kingdom

  • Hospices Civils de Lyon Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495, France

  • Hospital Infanta Leonor

    Madrid, 28031, Spain

  • Hospital Marina Baixa

    Villajoyosa, 03570, Spain

  • Hospital Universitario de La Paz

    Madrid, 28046, Spain

  • Hospital de La Santa Creu I Sant Pau

    Barcelona, 08041, Spain

  • Hospital de Manises

    Manises, 46940, Spain

  • Inselspital Universitatsklinik Fur Medizinische Onkologie

    Bern, 03010, Switzerland

  • International Clinical Research Tennessee Llc

    Murfreesboro, Tennessee, 37130, United States

  • Irccs Istituto Clinico Humanitas

    Rozzano, 20089, Italy

  • Klinika Ambroziak Dermatologia

    Warsaw, 02-953, Poland

  • Lane Dermatology and Dermatologic Surgery

    Columbus, Georgia, 31904, United States

  • Lynderm Research Inc

    Markham, Ontario, L3P 1X3, Canada

  • Lynn Institute of the Ozarks

    Little Rock, Arkansas, 72204, United States

  • Marietta Dermatology the Skin Cancer Center Marietta

    Marietta, Georgia, 30060, United States

  • Medderm Associates, Inc

    San Diego, California, 92103, United States

  • Medical Center Assoc. Prof. Vasilev

    Sofia, 01618, Bulgaria

  • Medical Center Hera Eood

    Sofia, 01510, Bulgaria

  • Medical Center Medconsult Pleven Ood

    Pleven, 05800, Bulgaria

  • Mhat Dr. Tota Venkova Ad

    Gabrovo, 05300, Bulgaria

  • North Sound Dermatology

    Mill Creek, Washington, 98012, United States

  • Northampton General Hospital

    Northampton, NN1 5BD, United Kingdom

  • Northshore University Healthsystem

    Skokie, Illinois, 60077, United States

  • Oakland Hills Dermatology Pc

    Auburn Hills, Michigan, 48326, United States

  • Obudai Egeszsegugyi Centrum Kft.

    Budapest, 01036, Hungary

  • Paratus Clinical Research, Woden

    Phillip, 02606, Australia

  • Pratia McM Krakow

    Krakow, 30-727, Poland

  • Praxis Fuer Haut- Und Geschlechtskrankheiten Dr. Med. Thomas Wildfeuer Und Partner

    Berlin, 13055, Germany

  • Premier Specialists Pty Ltd

    Kogarah, New South Wales, 02217, Australia

  • Rainey and Finklea Dermatology

    San Antonio, Texas, 78213, United States

  • Revival Research Institute, Llc Troy

    Troy, Michigan, 48084, United States

  • Santa Sp. Z O.O. Santa Familia Ptg Lodz

    Lodz, 90-302, Poland

  • Semmelweis Egyetem

    Budapest, 01085, Hungary

  • Skin Centre For Dermatology

    Peterborough, Ontario, K9J 5K2, Canada

  • Skin Health Institute Inc.

    Carlton, Victoria, 03053, Australia

  • Skincare Studio Dermatology Centre

    St. John's, A1E 1V4, Canada

  • Solumed Centrum Medyczne

    Poznan, 60-529, Poland

  • Szegedi Tudomanyegyetem Aok Szent-Gyorgyi Albert Klinikai Kozpont

    Szeged, 06720, Hungary

  • Texas Dermatology Research Center

    Plano, Texas, 75025, United States

  • Twoja Przychodnia - Szczecinskie Centrum Medyczne

    Szczecin, 71- 500, Poland

  • Ulb Hospital Erasme

    Brussels, 01070, Belgium

  • Universita Degli Studi Della Campania Luigi Vanvitelli

    Naples, 80131, Italy

  • Universitaetsklinikum Augsburg Sued

    Augsburg, 86179, Germany

  • Universitair Medisch Centrum Groningen

    Groningen, 9713GZ, Netherlands

  • Universitair Ziekenhuis Antwerpen (Uza)

    Edegem, 02650, Belgium

  • Universitair Ziekenhuis Gent (Uz Gent)

    Ghent, 09000, Belgium

  • Universitatsklinikum Munster

    Münster, 48149, Germany

  • Universitatsspital Basel

    Basel, CH-4055, Switzerland

  • Universitatsspital Zurich

    Zurich, 08091, Switzerland

  • University Hospital Plymouth

    Plymouth, PL6 8DH, United Kingdom

  • University Hospital of Saint Etienne

    Saint-Etienne, 42055, France

  • Veracity Clinical Research

    Woolloongabba, Queensland, 04102, Australia

  • Walsall Manor Hospital

    Walsall, WS2 9PS, United Kingdom

  • West Middlesex University Hospital

    Isleworth, TW7 6AF, United Kingdom

  • Wiseman Dermatology Research Inc

    Winnipeg, Manitoba, R3M 3Z4, Canada

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