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New cream offers hope for kids with stubborn eczema

NCT ID NCT06832618

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 20, 2026 · Updated 2 times

Summary

This study tests a prescription cream called ruxolitinib for children and teens (ages 6 to 17) with moderate eczema. The cream is applied to the skin to reduce redness, itching, and rash. Researchers want to see if it works better than a cream with no medicine and check for side effects.

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

159 people

The number who actually took part.

Started

Jun 2025

Expected to finish

Sep 2027

An estimate. End dates often move.

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

6 to 17 years

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: * Aged 6 to \< 18 years at the VC Day 1 visit. * Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria. * AD duration of at least 3 months for 6 to 11 year olds and at least 2 years for 12 to \< 18 year olds (participant/parent/guardian may verbally report signs and symptoms of AD). * EASI score \> 7 at the screening and VC Day 1 visits. * IGA score of 3 at the screening and VC Day 1 visits. * Percent BSA (excluding the scalp) with AD involvement of at least 3% and up to 20% at the screening and VC Day 1 visits. * Itch NRS or WI NRS score ≥ 4 at the screening and VC Day 1 visits, defined as the average of the 7 days directly before the VC/Day 1 visit, with Itch NRS or WI NRS values available for at least 4 of the 7 days. * Documented recent history (within 12 months before the screening visit) of inadequate response, intolerance, or contraindication to TCSs and TCIs as follows: * Inadequate response: * For TCSs: Inability of a given TCS to induce and maintain remission or to contain the AD severity at an acceptable level (comparable to an IGA score of 0 \[clear\] or 1 \[almost clear\]) despite treatment for 28 days or for the maximum duration recommended by the product prescribing information (eg, 14 days for superpotent TCSs), whichever is shorter and * For TCIs: Inability of a given TCI to induce and maintain remission or to contain the AD severity at an acceptable level (comparable to an IGA score of 0 \[clear\] or 1 \[almost clear\]) despite treatment according to the product prescribing information. Note: Documented (within 12 months before the screening visit) systemic treatment for AD (eg, oral corticosteroids, cyclosporine, methotrexate, azathioprine, mycophenolate mofetil) or phototherapy or photo(chemo)therapy can also be considered as a surrogate for inadequate response to TCSs and TCIs. • Intolerance: Clinically relevant side effects, safety risks, or skin tolerability issues that outweigh the potential treatment benefits and are the reason why a topical treatment could not be restarted or continued. Note: Documented history (more than 12 months prior to the screening visit) of clinically significant adverse reactions with use of TCSs and/or TCIs that in the opinion of the investigator outweigh the benefits of restarting treatment would also be considered as evidence of intolerance. • Contraindication: As defined in the product prescribing information. * Agreement by participants and guardians to discontinue all agents used by the participant to treat AD from the screening visit through the final safety follow-up visit, except as outlined in the protocol. * For sexually active participants, willingness to take appropriate contraceptive measures to avoid pregnancy or fathering a child for the duration of study participation with the exception of prepubescent participants. Note: Female participants who have reached menarche must have a negative urine pregnancy test at the screening and baseline visits before the first application of study cream at baseline. They must also take appropriate precautions to avoid pregnancy from the screening visit through the safety follow-up visit. \- Ability to comprehend and willingness to sign an ICF or written informed consent of the parent(s) or legal guardian and a verbal or written assent from the participant when possible. Note: A signed written ICF must be obtained for inclusion; see protocol. Exclusion Criteria: * Unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to the VC Day 1 visit. * 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 the VC Day 1 visit. * Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex, herpes zoster, chickenpox) within 1 week before the VC Day 1 visit. * 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: * Absolute neutrophil count \< 1000/μL. * Platelet count \< 100,000/μL. * AST or ALT ≥ 2 × ULN. * Alkaline phosphatase \> 1.5 × ULN. * Bilirubin \> 1.5 × ULN (isolated bilirubin \> 1.5 × ULN is acceptable if bilirubin isfractionated and direct bilirubin \< 35%) with the exception of Gilbert disease. * Estimated glomerular filtration rate \< 30 mL/min/1.73 m2 (using the Modification of Diet in Renal Disease 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 the VC Day 1 visit: * 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 (eg, mycophenolate or tacrolimus) agents. * 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. * Pregnant or lactating participants or those considering pregnancy during the period of their study participation. * Living with anyone participating in any current Incyte-sponsored ruxolitinib cream study. * Known allergy or reaction to any component of the study cream formulation. * In the opinion of the investigator, unable or unlikely to comply with the administration schedule, study evaluations, and procedures (eg, eDiary compliance). * Committed to a mental health institution by virtue of an order issued either by the judicial or the administrative authorities. * Employees of the sponsor, sponsor delegates (eg, contract research organizations), or investigators or are otherwise dependents of them. * The following participants are excluded in France: vulnerable populations according to article L.1121-6 of the French Public Health Code and adults under legal protection, or who are unable to express their consent per article L.1121-8 of the French Public Health Code, not affiliated to a social security per article L.1121-8-1 of the French Public Health Code. * In the EU, participants considered incapacitated (according to CTR Article 31).

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Conditions

The condition(s) this trial relates to.

atopic eczema

As listed by the trial registrant

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

Atopic dermatitis

Contacts and locations

Locations

  • Az Sint-Lucas

    Ghent, 09000, Belgium

  • Azienda Ospedale Universita Di Padova

    Padova, 35128, Italy

  • Azienda Ospedaliera Universitaria Federico Ii

    Naples, 80131, Italy

  • Azienda Ospedaliero Universitaria Policlinico G.Rodolico San Marco

    Catania, 95123, Italy

  • Bacs-Kiskun Varmegyei Oktatokorhaz

    Kecskemét, 06000, Hungary

  • Bordeaux Chu Hopital Saint - Andre

    Bordeaux, 33000, France

  • Centre Hospitalier Universitaire de Liege - Sart Tilman

    Liège, 04000, Belgium

  • Centre de Recherche Saint-Louis

    Montreal, Quebec, H1Y3LI, Canada

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

    Gdansk, 80-546, Poland

  • Centrum Medyczne Evimed

    Warsaw, 02-625, Poland

  • Chu Sainte-Justine

    Montreal, Quebec, H3T 1C5, Canada

  • Chu de Quebec Universite Laval

    Québec, Quebec, G1V 4G2, Canada

  • Cincinnati Childrens Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Cleaver Medical Group

    Cumming, Georgia, 30040, United States

  • Clinexpert Kft.

    Budapest, 01033, Hungary

  • Clinical Best Solutions Sp. Z O.O. Sp. K.

    Lublin, 20-011, Poland

  • Clinical Research Center of Alabama

    Birmingham, Alabama, 35209, United States

  • Cliniques Universitaires Ucl Saint-Luc

    Brussels, 01200, Belgium

  • Complejo Hospitalario Universitario de Santiago

    Santiago de Compostela, 15706, Spain

  • Debreceni Egyetem Klinikai Kozpon Belgyogy Klinika

    Debrecen, 04032, Hungary

  • Dermatologie Maldegem

    Maldegem, 09990, Belgium

  • Dermatology Research Institute Inc.

    Calgary, Alberta, T2J 7E1, Canada

  • Dermmedica Sp. Z O.O.

    Wroclaw, 51-503, Poland

  • Dermoklinika

    Lodz, 90-436, Poland

  • Diamond Clinic Sp. Z O.O.

    Krakow, 31-559, Poland

  • Dr. Chih-Ho Hong Medical Inc.

    Surrey, British Columbia, V3R 6A7, Canada

  • Drk Krankenhaus Chemnitz-Rabenstein

    Chemnitz, 09117, Germany

  • Encore Medical Research, Llc Hollywood

    Hollywood, Florida, 33024, United States

  • Endeavor Health Medical Group

    Skokie, Illinois, 60077, United States

  • Etg Warszawa

    Warsaw, 02-677, Poland

  • Facet Dermatology

    Toronto, Ontario, M4E 1R7, Canada

  • Fachklinik Bad Bentheim Dermatologie

    Bad Bentheim, 48455, Germany

  • Fondazione Irccs Ca Granda Ospedale Maggiore

    Milan, 20122, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli Irccs

    Rome, 00168, Italy

  • Frontier Dermatology

    Mill Creek, Washington, 98012, United States

  • Geomedical Orvosi Kft.

    Budapest, 01066, Hungary

  • Grand Hôpital de Charleroi-Les Viviers

    Gilly, 06060, Belgium

  • Grazyna Pulka Centrum Medyczne All Med Spolka Komandytowa

    Krakow, 30-033, Poland

  • Gyncentrum Sp. Z O.O.

    Katowice, 40-600, Poland

  • Henry Ford Health System

    Detroit, Michigan, 48202, United States

  • High-Med Przychodnia Specjalistycza

    Warsaw, 01-817, Poland

  • Hopitaux Drome Nord

    Romans-sur-Isère, 26102, France

  • Hospital General Unviersitario de Alicante

    Alicante, 03010, Spain

  • Hospital Regional Universitario de Malaga

    Málaga, 29010, Spain

  • Hospital Sant Joan de Deu

    Esplugues de Llobregat, 08950, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Puerta de Hierro de Majadahonda

    Madrid, 28222, Spain

  • Hospital Universitario Virgen de Las Nieves

    Granada, 18014, Spain

  • Hospital Universitario de La Paz

    Madrid, 28046, Spain

  • Hospital de La Santa Creu I Sant Pau

    Barcelona, 08041, Spain

  • Hospital de Manis

    Manises, 46940, Spain

  • Kirk Barber Research

    Calgary, Alberta, T2G 1B1, Canada

  • Lane Dermatology and Dermatologic Surgery

    Columbus, Georgia, 31904, United States

  • Laster Rejuvenation Clinics Edmonton D.T. Inc.

    Edmonton, Alberta, T5J 3S9, Canada

  • Leader Research

    Hamilton, Ontario, L8L 3C3, Canada

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Medisearch Clinical Trials

    Saint Joseph, Missouri, 64506, United States

  • Mics Centrum Medyczne Toruń

    Torun, 87-100, Poland

  • Mics Centrum Medyczne Warszawa Chlodna

    Warsaw, 00-872, Poland

  • National Jewish Health

    Denver, Colorado, 80206, United States

  • Oakland Hills Dermatology Pc

    Auburn Hills, Michigan, 48326, United States

  • Obudai Egeszsegugyi Centrum Kft.

    Budapest, 01036, Hungary

  • Pecsi Tudomanyegyetem

    Pécs, 07632, Hungary

  • Polyclinique Reims-Bezannes

    Reims, 51100, France

  • Raven Clinical Research

    Marriottsville, Maryland, 21104, United States

  • Red River Research Partners

    Bolivar, Missouri, 65613, United States

  • Saguaro Dermatology

    Phoenix, Arizona, 85008, United States

  • Semmelweis Egyetem

    Budapest, 01083, Hungary

  • Sheffield Childrens Hospital

    Sheffield, S10 2TH, United Kingdom

  • Skincare Studio Dermatology Centre

    St. John's, A1E 1V4, Canada

  • Skinsense Medical Research

    Saskatoon, Saskatchewan, S7K 2C1, Canada

  • Sneeze Wheeze and Itch Associates Llc

    Normal, Illinois, 61761, United States

  • St John'S Institute of Dermatology

    London, SE1 7EH, United Kingdom

  • Szegedi Tudomanyegyetem Aok Szent-Gyorgyi Albert Klinikai Kozpont

    Szeged, 06720, Hungary

  • The Adam Practice

    Metropolitan Borough of Wirral, CH49 5PE, United Kingdom

  • Treasure Valley Medical Research

    Boise, Idaho, 83706, United States

  • Twoja Przychodnia - Szczecinskie Centrum Medyczne

    Szczecin, 71- 500, Poland

  • Universitaetsklinikum Carl Gustav Carus Tu Dresden

    Dresden, 01307, Germany

  • Universitaetsklinikum Schleswig-Holstein - Campus Kiel

    Kiel, 24105, Germany

  • Universitair Ziekenhuis Gent

    Ghent, 09000, Belgium

  • Universitatsklinikum Bonn Aoer

    Bonn, 53127, Germany

  • Universitatsklinikum Frankfurt

    Frankfurt, 60590, Germany

  • Universitatsklinikum Munster

    Münster, 48149, Germany

  • Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

    Mainz, 55131, Germany

  • Universitatsmedizin Goettingen

    Göttingen, 37075, Germany

  • University of British Columbia (Ubc) - British Columbia Children'S Hospital (Bc Children'S Hospital)

    Vancouver, British Columbia, V6H 3V4, Canada

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216, United States

  • University of Nottingham Health Service

    Nottingham, NG7 2QW, United Kingdom

  • University of Rochester Medical Center

    Rochester, New York, 14620, United States

  • University of Texas Physicians - Bellaire Station

    Bellaire, Texas, 77401, United States

  • Walsall Manor Hospital

    Walsall, WS2 9PS, United Kingdom

  • West Glasgow Ambulatory Care Hospital

    Glasgow, G3 8SJ, United Kingdom

  • Winnipeg Clinic

    Winnipeg, Manitoba, R3C 0N2, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.