Study on the Effectiveness of Ruxolitinib Cream for Adults with Moderate Atopic Dermatitis

1 1

What is this study about?

This clinical trial is focused on studying the effects of a treatment for Atopic Dermatitis, a common skin condition that causes red, itchy, and inflamed skin. The treatment being tested is a cream containing Ruxolitinib, which is applied to the skin. The study aims to determine how effective and safe this cream is for adults who have moderate atopic dermatitis and have not responded well to other treatments like topical corticosteroids or topical calcineurin inhibitors.

Participants in the study will be randomly assigned to use either the Ruxolitinib cream or a similar cream without the active ingredient, known as a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the active treatment or the placebo. This helps ensure that the results are unbiased. The study will last for several weeks, during which participants will apply the cream to their skin and attend regular check-ups to monitor their progress and any side effects.

The main goal of the study is to see if the Ruxolitinib cream can significantly improve the symptoms of atopic dermatitis, such as reducing the severity of skin inflammation and itchiness. Participants’ skin condition will be assessed at various points throughout the study to track improvements. The study will also gather information on any side effects experienced by participants to ensure the treatment is safe. This research could potentially lead to a new treatment option for those suffering from moderate atopic dermatitis.

1 joining the study

Upon joining the study, the participant will be required to stop using any other treatments for atopic dermatitis, except as specified in the study protocol.

Participants must agree to avoid pregnancy or fathering children during the study and for a specified period after the last application of the study cream.

2 initial assessment

Participants will undergo an initial assessment to confirm eligibility, which includes a diagnosis of moderate atopic dermatitis and specific scores on various scales measuring the severity of the condition.

3 treatment phase

Participants will be randomly assigned to receive either the ruxolitinib cream or a vehicle cream without the active substance.

The cream is applied to the skin (cutaneous use) as directed by the study protocol.

4 monitoring and follow-up

Participants will be monitored regularly to assess the effectiveness and safety of the treatment.

The primary goal is to achieve significant improvement in the severity of atopic dermatitis by Week 8, as measured by specific clinical scales.

5 completion of the study

The study is expected to conclude by December 2025, with final assessments conducted to evaluate the long-term effects of the treatment.

Who Can Join the Study?

  • Must be an adult aged 18 years or older.
  • Agree to stop using all treatments for Atopic Dermatitis (AD) during the study, except for specific exceptions mentioned in the study protocol.
  • Must agree to avoid pregnancy, breastfeeding, or fathering children during the study and for a certain period after the last use of the study cream. This includes using approved methods to prevent pregnancy.
  • Must be able to understand and willing to sign an Informed Consent Form (ICF), which is a document explaining the study and confirming your agreement to participate.
  • Must have a diagnosis of Atopic Dermatitis (AD) according to specific criteria set by Hanifin and Rajka in 1980.
  • Must have had AD for at least 2 years.
  • Must have an Investigator’s Global Assessment (IGA) score of 3 at the start of the study. This score helps measure the severity of AD.
  • Must have an Eczema Area and Severity Index (EASI) score greater than 7 at the start of the study. This score measures the extent and severity of eczema.
  • Must have an Itch Numeric Rating Scale (NRS) score of 4 or higher at the start of the study. This score measures the intensity of itching over the past week.
  • Must have Atopic Dermatitis affecting at least 10% and up to 20% of the body surface area, excluding the scalp, at the start of the study.
  • Must have a Dermatology Life Quality Index (DLQI) score greater than 10 at the start of the study. This score measures the impact of skin disease on your life.
  • Must have a recent history (within the last 12 months) of not responding well, being intolerant, or having a reason not to use Topical Corticosteroids (TCSs) and Topical Calcineurin Inhibitors (TCIs), which are common treatments for AD.

Who Cannot Join the Study?

  • Participants who have a known allergy or sensitivity to the study medication or its ingredients.
  • Individuals with a history of certain skin conditions that might interfere with the study, such as severe forms of eczema.
  • People who have used certain medications that could affect the study results, like strong steroids, within a specific time before the study starts.
  • Participants with any other medical condition that the study doctors believe could make it unsafe for them to participate.
  • Individuals who are pregnant or breastfeeding, as the effects of the study medication on unborn babies or infants are not known.
  • People who are currently participating in another clinical trial or have recently participated in one.
  • Participants who have a history of not following medical advice or treatment plans, which could affect the study’s results.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Hospital De Manises Manises Spain
Medical Center Hera EOOD Sofia Bulgaria
Universitair Ziekenhuis Gent Gent Belgium
Centre Hospitalier Lyon Sud Pierre Benite France
Amphia Hospital Breda The Netherlands
Grand Hopital De Charleroi Charleroi Belgium
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o. Szczecin Poland
Santa Sp. z o.o. Lodz Poland
Hospital Universitario Infanta Leonor Madrid Spain
Hospital Marina Baixa De La Vila Joiosa Villajoyosa Spain
Solumed Sp. z o.o. sp.k. Poznan Poland
Centrum Medyczne All-Med Badania Kliniczne Cracow Poland
Klinika Ambroziak Sp. z o.o. Warsaw Poland
ASSOCIATIE DERMATOLOGIE Suys Erwin en Bonny Michiel FV Kortrijk Belgium
Obudai Egeszseguegyi Centrum Kft. Dunaújváros Hungary
University Of Debrecen Debrecen Hungary
Clinexpert Kft. Budapest Hungary
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Semmelweis University Budapest Hungary
Multiprofile Hospital For Active Treatment Dr. Tota Venkova AD Gabrovo Bulgaria
Pratia S.A. Skorzewo Poland
Centre Hospitalier Universitaire De Nantes Nantes France
Bravis Ziekenhuis Roosendaal The Netherlands
MVZ Corius Potsdam GmbH Potsdam Germany
Doctor Vasilev Medical Center Ltd. Sofia Bulgaria
University Of Szeged Szeged Hungary
ASMC – IPSMC – Skin And Venereal Diseases Sofia Bulgaria
Groupement Des Hopitaux De L’Institut Catholique De Lille lomme France
Vital Medical Center Veszprem Hungary
Cocrpxmpr Uuikdvdcljbfko Sfgmbrkvq Woluwe-Saint-Lambert Belgium
Dbjzkhhkuw Azk Conktejrfg Cfskwq Xfpolexzvuye Ecdk Sofia Bulgaria
Uhqzxdlgfcgg Minmjbk Cxeamqp Gfoyzjcfr Groningen The Netherlands
Uuroqtiohydtpzapsadrx Abvoespm Augsburg Germany
Cpbcnlk Badth Knajowfshed Pijotrpx Ssi z odfk Gdansk Poland
Tooixaaxbrk uhf Shwqwixgqhf Bctccmfd Gpuy Bad Bentheim Germany
Pkfeeph Mtfknr Sfm z Ovpx Ejg Pgxtafsry Poniatowa Poland
Unmqbblmbmjuopympifcn Mlrmnapw Agm Munster Germany
Dcnohmzztm Sht z oznv Wroclaw Poland
Hxalnpag Dc Ld Sesuz Cqvh I Sqlc Pxw Barcelona Spain
Ueafjksyrk Oc Afttcke Edegem Belgium
Fslyyqhtw Pwzj Ly Ipgzktwqvaewm Bkbybhkqv Ddz Hpzbwxgj Uqnybsfcfshwz Lz Psu Madrid Spain
Hdnsbfju Uplrzseyyzbds Hmnafrll Tpjlx y Pbpwlw Iefuprww Cticcg dnfpefpmsykbfqdra (fpcx Badalona Spain
Mxcyanh Cysvdz Mlmdkjhxjm Pvmeng Oqw Pleven Bulgaria
Iqgqanry dc Cppmvimevdcc Hfrhfhzukxk Uczjjgylziadu df Sipxs Ejwdtyc (brkraat Saint Priest En Jarez France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
10.09.2024
Bulgaria Bulgaria
Not recruiting
10.09.2024
France France
Not recruiting
10.09.2024
Germany Germany
Not recruiting
10.09.2024
Hungary Hungary
Not recruiting
10.09.2024
Italy Italy
Not recruiting
10.09.2024
Poland Poland
Not recruiting
10.09.2024
Spain Spain
Not recruiting
10.09.2024
The Netherlands The Netherlands
Not recruiting
10.09.2024

Trial locations

Investigated drugs:

Ruxolitinib Cream is a topical medication used in this clinical trial to treat adults with moderate atopic dermatitis. It is applied directly to the skin and works by reducing inflammation and itching associated with the condition. The trial aims to determine how effective and safe this cream is for people who have not responded well to other treatments like topical corticosteroids (TCSs) and topical calcineurin inhibitors (TCIs), or for those who cannot use these treatments due to intolerance or other reasons.

Atopic Dermatitis – Atopic dermatitis is a chronic skin condition characterized by dry, itchy, and inflamed skin. It often begins in childhood but can occur at any age. The skin may become red, swollen, and cracked, and in some cases, blisters may form. The condition tends to flare periodically and then subside. It is commonly associated with other allergic conditions like asthma and hay fever. The exact cause is unknown, but it is believed to involve a combination of genetic and environmental factors.

Trial ID:
2023-505433-27-00
Protocol code:
INCB 18424-326
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • JNJ-95597528 for Adults with Moderate to Severe Atopic Dermatitis

    Recruiting

    Investigated diseases:
    Germany Poland
  • Testing two moisturizing creams with urea, propylene glycol, and propylene glycol alone for preventing flare-ups in patients with atopic dermatitis

    Recruiting

    1 1 1
    Investigated drugs:
    Norway Sweden