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Itch-Busting cream shows promise for painful skin bumps

NCT ID NCT05764161

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tested a cream called ruxolitinib (also known as Opzelura) in 190 adults with prurigo nodularis, a skin condition causing intense itching and hard bumps. Participants applied the cream twice daily for 12 weeks. The main goal was to see if it could reduce itch by at least 4 points on a 0–10 scale. The study is complete, and results suggest the cream may help ease itching.

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 (1.5%)
What this could lead to
If successful, this cream could provide a new, non-invasive option to reduce severe itching in people with prurigo nodularis.
What could go wrong
This is a completed Phase 3 trial, but results may not apply to all patients. The cream only targets itch, not the underlying cause, and long-term safety is still being studied.

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

190 people

The number who actually took part.

Started

Jun 2023

Finished

Nov 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 to 99 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: * Clinical diagnosis of PN ≥ 3 months before screening. * ≥ 6 pruriginous lesions on ≥ 2 different body areas (such as right and left leg) at screening and baseline having a treatment area \<20% BSA. * IGA-CPG-S score of ≥ 2 at screening and baseline. * Baseline PN-related WI-NRS score ≥ 7. * Willingness to avoid pregnancy or fathering children. Exclusion Criteria: * Chronic pruritus due to a condition other than PN * Total estimated BSA treatment area (excluding the scalp) \> 20%. * Neuropathic and psychogenic pruritus * Active atopic dermatitis lesions within 3 months of screening and baseline. * Uncontrolled thyroid function * Concurrent skin or other serious or unstable medical conditions which may interfere with the evaluation of PN such as immunocompromised status, acute/chronic infections, active malignancy, history of TB, history of DVT/VTE, etc Protocol defined abnormal laboratory results. * Use of any protocol-defined prohibited medication unless a washout is completed or use of medication known to cause itching. * Psoralen and ultraviolet A or ultraviolet B therapy within 4 weeks before baseline or Ultraviolet light therapy or prolonged exposure to natural or artificial sources of ultraviolet radiation (within 2 weeks before baseline * Pregnant or lactating, or considering pregnancy. * History of alcoholism or drug addiction within 1 year * Known allergy or reaction to any of the components of the study drug. * Committed to a mental health institution by virtue of an order issued either by the judicial or the administrative authorities. * Employees of the sponsor or investigator or otherwise dependents of them. * The following participants are excluded in France: 1. Vulnerable populations according to article L.1121-6 of the French Public Health Code. 2. Adults under legal protection or who are unable to express their consent per article L.1121-8 of the French Public Health Code. 3. Individuals not affiliated with the social security system.

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Conditions

The condition(s) this trial relates to.

dermatitis prurigo prurigo nodularis skin disorder

As listed by the trial registrant

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

Prurigo nodularis

Contacts and locations

Locations

  • Activmed Practices Research, Llc Beverly

    Beverly, Massachusetts, 01915, United States

  • Ajou University Hospital

    Suwon, 16499, South Korea

  • Ars - Maitland Clinical Research Unit

    Orlando, Florida, 32819, United States

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Aventiv Research Inc-Dublin

    Dublin, Ohio, 43016, United States

  • Axon Clinical Research

    Baltimore, Maryland, 21237, United States

  • Azienda Ospedaliera Di Perugia - Ospedale Santa Maria Della Misericordia

    Perugia, 06132, Italy

  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata

    Rome, 00133, Italy

  • Azienda Ospedaliero Universitaria Pisana - Ospedale S. Chiara

    Pisa, 56126, Italy

  • Bordeaux Chu Hopital Saint - Andre

    Bordeaux, 33000, France

  • Ceim Hospital Universitari Germans Trias I Pujol

    Badalona, 08916, Spain

  • Centre Hospitalier Universitaire Vaudois (Chuv)

    Lausanne, 01011, Switzerland

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers, 86021, France

  • Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. Z O.O.

    Malbork, 82-200, Poland

  • Chu Amiens - Hopital Sud

    Salouël, 80480, France

  • Chu Dijon-Bourgogne

    Dijon, 21000, France

  • Chu de Nice - Hospital L Archet

    Nice, 06200, France

  • Clinica Gaias Santiago

    Santiago de Compostela, 15002, Spain

  • Clinical Science Institute Clinical Research Specialists Inc

    Santa Monica, California, 90404, United States

  • Cura Clinical Research

    Sherman Oaks, California, 91403, United States

  • Dcc 'Alexandrovska', Eood

    Sofia, 01431, Bulgaria

  • Dermaceum Centrum Badan Klinicznych

    Wroclaw, 50-414, Poland

  • Dermatologische Gemeinschaftspraxis Mahlow

    Mahlow, 15831, Germany

  • Dermatology & Skin Care Clinic

    Buochs, 06374, Switzerland

  • Dermatology Research Associates

    Los Angeles, California, 90045, United States

  • Dermdox Center For Dermatology

    Sugarloaf, Pennsylvania, 18249, United States

  • Dermmedica Sp. Z O.O.

    Wroclaw, 51-318, Poland

  • Dermoklinika Centrum Medyczne S.C., M. Kierstan, J. Narbutt, A. Lesiak

    Lodz, 90-436, Poland

  • Dermresearch, Inc.

    Austin, Texas, 78759, United States

  • Diamond Clinic Specjalistyczne Poradnie Lekarskie

    Krakow, 31-559, Poland

  • Diex Recherche Quebec Inc.

    Québec, Quebec, G1V 4T3, Canada

  • Fondazione Irccs Ca Granda Ospedale Maggiore

    Milan, 20122, Italy

  • Herlev Og Gentofte Hospital

    Hellerup, 02900, Denmark

  • Holdsworth House Medical Practice

    Sydney, New South Wales, 02010, Australia

  • Hopital Edouard Herrio

    Lyon, 69003, France

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario de Gran Canaria Doctor Negrin

    Las Palmas de Gran Canaria, 35010, Spain

  • Kingsway Clinical Research

    Etobicoke, Ontario, M8X 1Y9, Canada

  • Klinikum Bielefeld Rosenhohe Dermatologie

    Bielefeld, 33647, Germany

  • Korea University Anam Hospital

    Seoul, 02841, South Korea

  • Korea University Guro Hospital

    Seoul, 08308, South Korea

  • Landeskrankenhaus Universitatsklinikum Graz

    Graz, 08036, Austria

  • Liverpool Hospital

    Liverpool, New South Wales, 02170, Australia

  • Luxderm Specjalistyczny Gabinet Dermatologiczny

    Lublin, 20-362, Poland

  • Lynderm Research Inc

    Markham, Ontario, L3P 1X3, Canada

  • Marietta Dermatology the Skin Cancer Center Marietta

    Marietta, Georgia, 30060-1047, United States

  • Medical Center Hera Eood

    Sofia, 01510, Bulgaria

  • Medical Center Medconsult Pleven Ood

    Pleven, 05800, Bulgaria

  • Medical Center Unimed Eood

    Sevlievo, 05400, Bulgaria

  • Medical Center- Prolet Ltd

    Rousse, 07000, Bulgaria

  • North York Research Inc.

    North YORK, Ontario, M2M 4J5, Canada

  • Northwest Arkansas Clinical Trials Center

    Arkansas City, Arkansas, 72758, United States

  • Oakview Dermatology

    Athens, Ohio, 45701, United States

  • Ordensklinikum Linz Gmbh Elisabethinen

    Linz, 04020, Austria

  • Paratus Clinical Research, Woden

    Phillip, 02606, Australia

  • Premier Specialists Pty Ltd

    Kogarah, New South Wales, 02217, Australia

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Sjaellands Universitetshospital

    Roskilde, 04000, Denmark

  • Skin Centre For Dermatology

    Peterborough, Ontario, K9J 5K2, Canada

  • Solumed Centrum Medyczne

    Poznan, 60-529, Poland

  • Sozialmedizinisches Zentrum Ost-Donauspital

    Vienna, 01220, Austria

  • The Alfred Hospital

    Melbourne, Victoria, 03004, Australia

  • The Catholic University of Korea Seoul St. Mary'S Hospital

    Seoul, 06591, South Korea

  • The South Bend Clinic Main Campus

    South Bend, Indiana, 46617, United States

  • Umhat Prof. Dr. Stoyan Kirkovich Ad

    Stara Zagora, 06000, Bulgaria

  • Universita Degli Studi Della Campania Luigi Vanvitelli

    Naples, 80131, Italy

  • Universitatsklinikum Frankfurt

    Frankfurt am Main, 60590, Germany

  • Universitatsklinikum Munster

    Münster, 48149, Germany

  • Universitatsmedizin Goettingen

    Göttingen, 37075, Germany

  • Universitatsspital Zurich

    Zurich-flughafen, 08058, Switzerland

  • University of Alabama At Birmingham

    Birmingham, Alabama, 35233, United States

  • University of Pittsburgh Medical Center Upmc Dermatology Clinic Oakland Falk Medical Building

    Pittsburgh, Pennsylvania, 15232, United States

  • Veracity Clinical Research

    Woolloongabba, Queensland, 04102, Australia

  • Westmead Hospital

    Sydney, New South Wales, 02145, Australia

  • Wright State Physicians, Inc.

    Fairborn, Ohio, 45324, United States

More trials for these conditions

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