Phase
Condition
Atopic Dermatitis
Dermatitis, Atopic
Hives (Urticaria)
Treatment
Vehicle Cream
Ruxolitinib
Clinical Study ID
Ages 2-11 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants diagnosed with Atopic Dermatitis (AD) as defined by the Hanifin andRajka criteria.
Participants with AD duration of at least 3 months (participant/parent/guardian mayverbally report signs and symptoms of AD with onset at least 3 months prior).
Participants with IGA score of 2 to 3 at the screening and baseline visits.
Participants with %BSA (excluding scalp) of AD involvement of 3% to 20% at screeningand baseline visits.
For children aged 6 years to < 12 years, baseline itch NRS score ≥ 4.
Participants/guardians who agree to discontinue all agents used by the participantto treat AD from the screening visit through the final safety follow-up visit.
Participants with at least 1 target lesion that measures at least 5 cm2 at thescreening and baseline visits. The target lesion must be representative of theparticipant's disease state but not located on the hands, feet, or genitalia.
Willingness to avoid pregnancy or fathering a child for the duration of studyparticipation.
Exclusion
Exclusion Criteria:
An unstable course of AD (spontaneously improving or rapidly deteriorating) asdetermined by the investigator over the previous 4 weeks before the baseline visit.
Concurrent conditions and history of other diseases as follows:
Immunocompromised
Chronic or acute infection requiring treatment with systemic antibiotics,antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeksbefore the baseline visit.
Active acute bacterial, fungal, or viral skin infection within 1 week beforethe baseline visit.
Any other concomitant skin disorder, pigmentation, or extensive scarring thatin the opinion of the investigator may interfere with the evaluation of ADlesions or compromise participant safety.
Presence of AD lesions only on the hands or feet without prior history ofinvolvement of other classic areas of involvement such as the face or theflexural folds.
Other types of eczema.
Chronic asthma requiring more than 880 µg of inhaled budesonide or equivalenthigh dose of other inhaled corticosteroids.
Any serious illness or medical, physical, or psychiatric condition(s) that, in theinvestigator's opinion, would interfere with full participation in the study,including administration of study drug and attending required study visits; pose asignificant risk to the participant; or interfere with interpretation of study data.
Use of any of the following treatments within the indicated washout period beforethe baseline visit:
5 half-lives or 12 weeks, whichever is longer - biologic agents (eg,dupilumab).
4 weeks - systemic corticosteroids or adrenocorticotropic hormone analogues,cyclosporin, methotrexate, azathioprine, or other systemic immunosuppressive orimmunomodulating agents (eg, mycophenolate or tacrolimus).
2 weeks - immunizations with activated vaccines; sedating antihistamines unlesson a long-term stable regimen (nonsedating antihistamines are permitted). Note:Live vaccines are not recommended during the VC period.
1 week - use of topical treatments for AD (other than bland emollients, eg,Aveeno® creams, ointments, sprays, soap substitutes), such as corticosteroids,calcineurin inhibitors, PDE4 inhibitors, coal tar (shampoo), topicalantibiotics, or antibacterial cleansing body wash/soap. Note: Diluted sodiumhypochlorite "bleach" baths are allowed as long as they do not exceed 2 bathsper week.
Participants who have previously received JAK inhibitors, systemic or topical. -Ultraviolet light therapy or prolonged exposure to natural or artificial sources ofUV radiation (eg, sunlight or tanning booth) within 2 weeks prior to the baselinevisit and/or intention to have such exposure during the study, which is thought bythe investigator to potentially impact the participant's AD.-
Positive serology test results at screening for HIV antibody.
Current treatment or treatment within 30 days or 5 half-lives (whichever is longer)before the baseline visit with another investigational medication or currentenrollment in another investigational drug protocol.
In the opinion of the investigator, unable or unlikely to comply with theadministration schedule and study evaluations.
Employees of the sponsor or investigator or otherwise dependents of them.
Study Design
Connect with a study center
Dermatology Research Institute
Calgary, Alberta T3A 2N1
CanadaSite Not Available
Vida Clinical Research
Edmonton, Alberta TGH 4J8
CanadaSite Not Available
Skinfitmd
Surrey, British Columbia V3R 6A7
CanadaSite Not Available
Leader Research
Burlington, Ontario L7R 4H9
CanadaSite Not Available
Ontario Pediatric Allergy Research Corporation
Burlington, Ontario L7L 6W6
CanadaSite Not Available
Leader Research
Hamilton, Ontario L8L 3C3
CanadaSite Not Available
Lynderm Research Inc
Markham, Ontario L3P 1X2
CanadaSite Not Available
Dermatology Ottawa Research Centre
Ottawa, Ontario K2C 3N2
CanadaSite Not Available
Probity Medical Research Inc Pmr
Waterloo, Ontario N2J 1C4
CanadaSite Not Available
University of Montreal
Montreal, Quebec H3T 1C5
CanadaSite Not Available
CHARIT� - UNIVERSIT�TSMEDIZIN BERLIN
Berlin, 13353
GermanySite Not Available
Charite Universitatsmedizin Berlin
Berlin, 13353
GermanySite Not Available
Katholisches Kinderkrankenhaus Wilhelmstift
Hamburg, 22149
GermanySite Not Available
Mensingderma Medic
Hamburg, 22391
GermanySite Not Available
Universitatsklinikum Schleswig Holstein
Kiel, 24105
GermanySite Not Available
University Medical Center Schleswig-Holstein, Campus Kiel
Kiel, 24105
GermanySite Not Available
Asst Spedali Civili Di Brescia
Brescia, 25123
ItalySite Not Available
Nuovo Ospedale San Giovanni Di Dio (Torregalli)
Firenze, 50143
ItalySite Not Available
Ospedale Piero Palagi
Firenze, 50125
ItalySite Not Available
Fondazione Irccs Ca Granda Ospedale Maggiore Policlinico Di Milano Uo Dermatologia
Milan, 20122
ItalySite Not Available
Azienda Ospedaliero Universitaria Ospedale Maggiore
Parma, 43126
ItalySite Not Available
Fondazione Policlinico Universitario Agostino Gemelli Irccs
Rome, 00168
ItalySite Not Available
Centrum Badan Klinicznych Pi-House Sp. Z O.O.
Gdansk, 80-546
PolandSite Not Available
Synexus Polska Sp. Z O.O. Oddzial W Gdansku
Gdansk, 80-382
PolandSite Not Available
Universyteckie Centrum Kliniczne Gdanskiego Uniwersytetu Medycznego Klinika Dermatologii, Wenerologi
Gdansk, 80-214
PolandSite Not Available
Angelius Badania Kliniczne
Katowice, 40-611
PolandSite Not Available
Dermoklinika Centrum Medyczne
Lodz, 90-436
PolandSite Not Available
Twoja Klinika
Mikolow, 43-190
PolandSite Not Available
Twoja Klinikal
Mikolów, 43-190
PolandSite Not Available
Clinical Research Group (Crg)
Warszawa, 02-201
PolandSite Not Available
Klinika Ambroziak
Warszawa, 02-758
PolandSite Not Available
Synexus Polska Sp Z O.O. Oddzial W Warszawie
Warszawa, 01-192
PolandSite Not Available
Dermmedica Sp. Z O.O.
Wroclaw, 02-507
PolandSite Not Available
Synexus Polska Sp. Z O.O. Oddzial We Wroclawiu
Wroclaw, 50-381
PolandSite Not Available
Hospital General Universitario de Alicante
Alicante, 03010
SpainSite Not Available
Hospital General Unviersitario de Alicante
Alicante, 03010
SpainSite Not Available
Hospital Universitario Germans Trias I Pujol
Barcelona, 08916
SpainSite Not Available
Hospital Universitario La Paz
Madrid, 28046
SpainSite Not Available
Clinica Universidad de Navarra (Cun)
Pamplona, 31008
SpainSite Not Available
The University of Sheffield - the Medical School - Sheffield Dermatology Research
Sheffield, S10 2RX
United KingdomSite Not Available
Clinical Research Center of Alabama
Birmingham, Alabama 35209
United StatesSite Not Available
Cahaba Dermatology
Hoover, Alabama 35244
United StatesSite Not Available
Physicians Research Group Ii
Gilbert, Arizona 85295
United StatesSite Not Available
Cct Research With Center For Dermatology and Plastic Surgery
Scottsdale, Arizona 85260
United StatesSite Not Available
Burke Pharmaceutical Research
Hot Springs National Park, Arkansas 71913
United StatesSite Not Available
First Oc Dermatology
Fountain Valley, California 92708
United StatesSite Not Available
Dermatology Research Associates
Los Angeles, California 90045
United StatesSite Not Available
Iact Health
Los Angeles, California 90017
United StatesSite Not Available
Metropolis Dermatology
Los Angeles, California 90017
United StatesSite Not Available
University of Southern California
Los Angeles, California 90033
United StatesSite Not Available
Madera Family Medical Group
Madera, California 93637
United StatesSite Not Available
Allergy & Asthma Associates of Southern California
Mission Viejo, California 92691
United StatesSite Not Available
Palmtree Clinical Research - Clinedge - Ppds
Palm Springs, California 92262
United StatesActive - Recruiting
Palmtree Clinical Research-Clinedge-Ppds
Palm Springs, California 92262
United StatesSite Not Available
Integrated Research of Inland, Inc
Riverside, California 92506
United StatesSite Not Available
Clinical Science Institute Clinical Research Specialists Inc
Santa Monica, California 90404
United StatesSite Not Available
Phdermatology
Clearwater, Florida 33756
United StatesSite Not Available
Life Clinical Trials Margate
Margate, Florida 33063
United StatesSite Not Available
Acevedo Clinical Research
Miami, Florida 33142
United StatesSite Not Available
Ciocca Dermatology Pa
Miami, Florida 33173
United StatesSite Not Available
Entrust Clinical Research
Miami, Florida 33156
United StatesSite Not Available
Pediatric Center of Excellence Pce Miami Pediatric Endocrinology, Llc
Miami, Florida 33146
United StatesSite Not Available
The Childrens Skin Center Csc Miami
Miami, Florida 33155
United StatesSite Not Available
Forcare Clinical Research
Tampa, Florida 33624
United StatesSite Not Available
Forcare Clinical Research Fcr Forward Clinical Trials, Inc
Tampa, Florida 33624
United StatesActive - Recruiting
Aeroallergy Research Lab of Savannah
Savannah, Georgia 31406
United StatesSite Not Available
Northwestern Memorial Hospital - Arkes Pavilion
Chicago, Illinois 60611
United StatesActive - Recruiting
Northwestern Memorial Hospital-Arkes Pavilion
Chicago, Illinois 60611
United StatesSite Not Available
Sneeze Wheeze and Itch Associates Llc
Normal, Illinois 61761
United StatesSite Not Available
Northshore Medical Group Dermatology Skokie
Skokie, Illinois 60076
United StatesSite Not Available
Dermatology Specialists Research Indiana
Clarksville, Indiana 47129
United StatesSite Not Available
Dawes Fretzin Clinical Research Group Llc
Indianapolis, Indiana 46250
United StatesSite Not Available
Kansas City Dermatology P.A.
Lenexa, Kansas 66215
United StatesSite Not Available
Office of Michael W. Simon, Md
Nicholasville, Kentucky 40356
United StatesSite Not Available
Delricht Clinical Research - Clinedge - Ppds Baton Rouge
Baton Rouge, Louisiana 70809
United StatesActive - Recruiting
Delricht Clinical Research-Clinedge-Ppds Baton Rouge
Baton Rouge, Louisiana 70809
United StatesSite Not Available
Meridian Clinical Research
Baton Rouge, Louisiana 70808
United StatesSite Not Available
Delricht Research - Touro Medical Center
New Orleans, Louisiana 70115
United StatesActive - Recruiting
Delricht Research-Touro Medical Center
New Orleans, Louisiana 70115
United StatesSite Not Available
Lawrence J. Green, Md. Llc
Rockville, Maryland 20850
United StatesSite Not Available
Henry Ford Medical Center - New Center One
Detroit, Michigan 48202
United StatesActive - Recruiting
Henry Ford Medical Center-New Center One
Detroit, Michigan 48202
United StatesSite Not Available
Michigan Dermatology Institute
Waterford, Michigan 48328
United StatesSite Not Available
Mayo Clinic
Rochester, Minnesota 55905
United StatesSite Not Available
Skin Specialists Pc the Advanced Skin Research Center
Omaha, Nebraska 68144
United StatesSite Not Available
Dr Bobby Buka, Md Greenwich Village
New York, New York 10012
United StatesSite Not Available
New York University Langone Medical Center - Fink Children'S Ambulatory Care Center
New York, New York 10016
United StatesActive - Recruiting
New York University Langone Medical Center-Fink Children'S Ambulatory Care Center
New York, New York 10016
United StatesSite Not Available
Ohio Pediatric Research Association
Dayton, Ohio 45414
United StatesSite Not Available
Velocity Clinical Research Grants Pass Clinical Research Institute of Southern Oregon Pc
Grants Pass, Oregon 97527
United StatesSite Not Available
Cyn3Rgy Research - Clinedge - Ppds
Gresham, Oregon 97030
United StatesActive - Recruiting
Cyn3Rgy Research-Clinedge-Ppds
Gresham, Oregon 97030
United StatesSite Not Available
Velocity Clinical Research - Medford
Medford, Oregon 97504
United StatesActive - Recruiting
Velocity Clinical Research-Medford
Medford, Oregon 97504
United StatesSite Not Available
Knight Cancer Institute At Oregon Health and Science University
Portland, Oregon 97239
United StatesSite Not Available
Oregon Dermatology and Research Center
Portland, Oregon 97210
United StatesSite Not Available
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania 17033
United StatesSite Not Available
Rhode Island Hospital
Providence, Rhode Island 02903
United StatesSite Not Available
Coastal Pediatric Associates
Charleston, South Carolina 29414
United StatesSite Not Available
Medical University of South Carolina
Charleston, South Carolina 29425
United StatesSite Not Available
International Clinical Research Tennessee Llc
Murfreesboro, Tennessee 37130
United StatesSite Not Available
Arlington Research Center
Arlington, Texas 76011
United StatesSite Not Available
Progressive Clinical Research
San Antonio, Texas 78213
United StatesSite Not Available
Texas Dermatology Alamo Heights Office
San Antonio, Texas 78218
United StatesSite Not Available
Allergy and Asthma Care of Waco, Pa
Waco, Texas 76712
United StatesSite Not Available
Intermountain Clinical Research Icr Draper
Draper, Utah 84020
United StatesSite Not Available
Springville Dermatology
Springville, Utah 84663
United StatesSite Not Available
Jordan Valley Dermatology Center
West Jordan, Utah 84088
United StatesSite Not Available
Skindc Clinic
Arlington, Virginia 22209
United StatesSite Not Available
Pi Coor Clinical Research Llc
Burke, Virginia 22015
United StatesSite Not Available
Clinical Research Partners Llc
Richmond, Virginia 23220
United StatesSite Not Available
Dermatology Specialists of Spokane
Spokane, Washington 99202
United StatesSite Not Available
Children'S Hospital of Wisconsin
Milwaukee, Wisconsin 53226
United StatesSite Not Available
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