Study of Ruxolitinib Cream for Children and Adolescents Ages 6-17 with Moderate Atopic Dermatitis Who Did Not Respond Well to Standard Treatments

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What is this study about?

This study focuses on children and teenagers aged 6 to 18 years who have moderate atopic dermatitis, a chronic inflammatory skin condition that causes itchy, red, and inflamed skin. The research evaluates a medication called ruxolitinib cream (also known as INCB018424 or Opzelura) compared to a cream without active ingredients (vehicle cream) in patients whose condition has not improved with standard treatments or who cannot use them.

The purpose of this research is to determine how well ruxolitinib cream works in treating moderate atopic dermatitis in young patients. During the study, participants will apply either ruxolitinib cream or the vehicle cream to affected areas of their skin, excluding the scalp. The treatment period lasts for 8 weeks, followed by an extended observation period.

The study will monitor changes in skin condition, including improvements in rash coverage, intensity of itching, and overall disease severity. Blood samples will be collected from some participants to measure how much of the medication enters the bloodstream. The research will also track any side effects that may occur during the treatment period.

1 Initial evaluation

Your atopic dermatitis (a skin condition causing itchy, inflamed skin) will be evaluated to confirm it meets the study criteria

The affected area must cover between 3% and 20% of your body surface (excluding scalp)

Your condition must be present for at least 3 months if you are 6-11 years old, or 2 years if you are 12-17 years old

2 Treatment phase – First 8 weeks

You will receive either ruxolitinib cream or a cream without active ingredient (vehicle cream) to apply to affected skin areas

The cream will be applied directly to the skin

Your skin condition will be monitored using several assessment tools:

– EASI score (measures the extent and severity of affected skin)

– IGA score (doctor’s assessment of disease severity)

– Itch rating (how intense your itching is)

3 Evaluations during treatment

Your progress will be checked at week 2, 4, and 8

Blood samples will be collected at week 2 and 8 to measure medication levels

You will complete questionnaires about your quality of life and symptoms

Your height, weight, and vital signs will be monitored

Laboratory tests will be performed to check your blood counts and chemistry

4 Disease control period

If your skin improves during the first phase, you may continue to the next phase

During this period, your skin condition will be monitored for any return of symptoms

The amount of cream used will be tracked

Regular assessments will continue to evaluate your skin condition

Who Can Join the Study?

Age between 6 and 18 years old at the first visit
If sexually active, must be willing to use appropriate birth control methods during the study (except for children who have not reached puberty)
Must be able to understand and willing to sign an informed consent form (parents or legal guardians must sign for minors)
Must have Atopic Dermatitis diagnosed according to specific medical criteria
Must have had Atopic Dermatitis for:
– At least 3 months for children aged 6-11 years
– At least 2 years for children aged 12-17 years
Must have a moderate level of skin symptoms, measured by:
– An EASI score (a measure of disease severity) greater than 7
– An IGA score (doctor’s assessment) of 3
– Affected body surface area between 3% and 20% (not including scalp)
Must have significant itching, with an average score of 4 or higher on a special scale during the week before the first visit
Must have documented proof within the last 12 months that standard skin treatments (topical corticosteroids and calcineurin inhibitors) either:
– Did not work well enough
– Caused unacceptable side effects
– Were not suitable for use in this patient
Must agree to stop using other treatments for Atopic Dermatitis during the study period, except those specifically allowed by the study doctors

Who Cannot Join the Study?

History of allergic reactions to ruxolitinib or similar medications
Active skin infections that require treatment
Current use of medications that could interfere with the study drug
Presence of other skin conditions that could interfere with evaluating atopic dermatitis
History of skin cancer or current suspicious skin lesions
Significant medical conditions that could affect study participation
Current participation in other clinical trials
Recent use of systemic treatments for atopic dermatitis (medications that affect the whole body)
Recent use of light therapy (phototherapy) for skin treatment
Pregnancy or breastfeeding
Known immune system disorders
History of serious infections in the past 3 months
Inability to follow study procedures or attend scheduled visits
Severe liver or kidney problems
Current or recent use of medications that suppress the immune system

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Diamond Clinic Sp. z o.o.	Cracow	Poland
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Technische Universitaet Dresden	Dresden	Germany
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Semmelweis Egyetem, Gyermekgyógyászati Klinika	Budapest	Hungary
Geomedical Kft.	Budapest	Hungary
Universitaetsmedizin Goettingen	Goettingen	Germany
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Gyncentrum Sp. z o.o.	Katowice	Poland
Evimed Sp. z o.o.	Warsaw	Poland

Other Sites

Site Name	City	Country
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany
Clinexpert Kft.	Budapest	Hungary
AZ Sint-Lucas & Volkskliniek	Gent	Belgium
Dermoklinika Centrum Medyczne s.c. M. Kierstan, J. Narbutt, A. Lesiak	Lodz	Poland
Mkgzfrqje Ibhmreuwai Cpenlcxz Ssbcwona Szr z omap	Warsaw	Poland
Cinpjyyau Uutdamrmugwxwa Sxgojmrlo	Woluwe-Saint-Lambert	Belgium
Upeibykspx Os Dzocnzvh	Debrecen	Hungary
Fupjcxptnw Iajve Ch Gjoujs Oskqjvsu Mvmiafws Pxjyzdbalqb	Milan	Italy
Uwccpiqjekvl Dw Sexrqzkv Dp Cahjqzwdbx	Santiago De Compostela	Spain
Uertalioupwvpcgqqsrcm Mhchgudw Aze	Munster	Germany
Atkgtio Osajyaehjdq Uxkieczjkcdzq Fcwyqibw Im Dz Nrmhys	Naples	Italy
Ulfomrdfjp Ob Spnxug	Szeged	Hungary
Hnyocter Dp Ll Sgmvx Cwqz I Slup Pie	Barcelona	Spain
Chnlbi hnlpddtnxyw uryiuhfxqcahg du Lxqeb	Liege	Belgium
Ugitmoydmtlj Zlwcmgzmvx Gprd	Gent	Belgium
Hlpeeqov Svce Jrdc Dz Dmg Bvdtpeuma	Esplugues De Llobregat	Spain
Uuejjlpywsonprswyacpz Stxmqravwftdxjdhkg Axv	Kiel	Germany
Hbeiexew Uodhorlfurtpm Pmxveb Di Hwxebb Dk Moojnidwluo	Majadahonda	Spain
Hqyxfbyd Ucjybxkygnggb 1q Dt Osmyvvg	Madrid	Spain
Fnrhezvlz Peqn Lc Izmpzutqldjaw Bmtenvvjw Dgc Hqyinswm Uwzzlnuvqvlpk Li Psm	Madrid	Spain
Cqggjfq Bjvlw Kgttmzkmfuv Phsdvkej Ssy z ouzo	Gdansk	Poland
Halrtzhs Ubrwqavtnwlfa Vqlyji Dh Lac Nqdmfp	Granada	Spain
Aoqpscf Olejxmvqetbfxvlaqqtulbwvu Pppgsuwjcxl Gw Rauxnjxgxghw Movlh Di Chrphsv	Catania	Italy
Eij Nyomggxuckkh Ssu z ojvl	Warsaw	Poland
Bgbkpljjwhy Vluxmteyw Obyzxfuwmhew	Kecskemet	Hungary
Oohafw Eiwjrmuitkbir Cwxojkq Kinm	Dunaújváros	Hungary
Gofcid Uptcrywwxc Ffvykhqlb	Frankfurt	Germany
Hqvhzeri Dcyvz Nvll	Romans-Sur-Isere	France
Ubcrktonhx Oq Ppfw	Pecs	Hungary
Dafghzbtwf Spl z ogup	Wroclaw	Poland
Gfnng Heduswk Do Cephchjtd	Charleroi	Belgium
Tvmhf Ppuumyfcntd Ssisldgtktdp Cwvupuk Molyxfar Sun z oxwi	Szczecin	Poland
Tnstbjqgvpx uid Slezgasmfsa Bpeuhvpr Gztf	Bad Bentheim	Germany
Cniwjish Bvmr Swomcddot Szj z oysj Suar	Lublin	Poland
Chqcbxq Mryywfwk Amxkucz Brmfsaq Kotafkjhm	Cracow	Poland
Asyyfrmyfr dpqfbhefmxjq Mfdagrdg	Maldegem	Belgium
Hudmmvqq Piflqhaoupt Suxtmnutozkvlxz	Warsaw	Poland
Crnuolisr Svaam	Reims	France

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	27.10.2025
France	Not recruiting	27.10.2025
Germany	Not recruiting	27.10.2025
Hungary	Not recruiting	27.10.2025
Italy	Not recruiting	27.10.2025
Poland	Not recruiting	27.10.2025
Spain	Not recruiting	27.10.2025

Trial locations

Investigated Drugs:

Ruxolitinib

Ruxolitinib cream is a topical medication used to treat moderate atopic dermatitis (eczema). It belongs to a class of drugs called JAK inhibitors, which work by reducing inflammation and itching in the skin. This cream is being studied specifically for children and teenagers aged 6 to 18 years who haven’t responded well to, cannot tolerate, or cannot use standard treatments like topical corticosteroids and topical calcineurin inhibitors.

Vehicle cream is a control product that contains the same base ingredients as the ruxolitinib cream but without the active medication. It’s used to compare the effectiveness of the active treatment in clinical trials.

Atopic Dermatitis – A chronic inflammatory skin condition that causes red, itchy, and dry patches on the skin. The condition typically develops in early childhood and can persist through adolescence and adulthood. It involves an overactive immune system response that leads to skin barrier dysfunction and inflammation. The affected areas commonly include the face, neck, inside of elbows, behind knees, and hands, with symptoms varying in intensity over time. The condition often follows a pattern of flare-ups and periods of remission, with triggers including stress, certain fabrics, environmental factors, and allergens.

Trial ID:

2024-518156-24-00

Protocol code:

INCB018424-316

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Ruxolitinib Cream for Children and Adolescents Ages 6-17 with Moderate Atopic Dermatitis Who Did Not Respond Well to Standard Treatments

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?