Phase
Condition
Hand Dermatitis
Eczema (Atopic Dermatitis - Pediatric)
Dermatitis, Atopic
Treatment
N/AClinical Study ID
Ages 18-99 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Diagnosis of chromic hand eczema (CHE) as defined by hand eczema (HE) lasting > 3months or ≥ 2 flares within the previous 12 months.
- Screening and baseline IGA-CHE 3 or 4.
- Baseline CHE-related Itch NRS ≥ 4.
- Recent history (within the past 1 year of baseline) of inadequate response totreatment with topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), ororal alitretinoin; or intolerance or contraindication to TCS or TCI or oralalitretinoin.
- Willingness to avoid pregnancy or fathering children based on the criteria below.
Exclusion
Exclusion Criteria:
- Known triggers for CHE (allergic or irritant, such as those identified by previouspatch tests) cannot be avoided during the course of this study.
- Participants who have an unstable course of AD (spontaneously improving or rapidlydeteriorating) as determined by the investigator in the 4 weeks prior to baseline.
- Participants with concurrent conditions and history of other diseases such as otheractive skin disease or infection on the hands; immunocompromised; chronic or acuteinfection requiring systemic treatments; active acute skin infection; otherconcomitant skin conditions that may interfere with study assessments or compromiseparticipant safety; other types of eczema; chronic asthma requiring high dose ofinhaled corticosteroids; current or history of hepatitis B or C virus infection.
- 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.
- Laboratory values outside of the protocol-defined criteria.
- Use of protocol-defined treatments within the indicated washout period beforebaseline.
- Psoralen ultraviolet A (PUVA) or ultraviolet B (UVB) therapy on the hands within 4weeks before baseline.
- Pregnant or lactating participants, or those considering pregnancy during the periodof their study participation.
- Further exclusion criteria apply.
Study Design
Connect with a study center
Dermatology Research Institute Inc.
Calgary, Alberta T2J 7E1
CanadaSite Not Available
Care Clinic
Red Deer, Alberta T4P-1K4
CanadaSite Not Available
Cca Medical Research
Ajax, Ontario L1S 7K8
CanadaSite Not Available
Lynderm Research Inc
Markham, Ontario L3P 1X3
CanadaSite Not Available
Fakultni Nemocnice U Sv. Anny V Brne
Brno, 656 91
CzechiaSite Not Available
Ccr Ostrava S.R.O.
Ostrava, 702 00
CzechiaSite Not Available
Ccr Czech A.S.
Pardubice, 53000
CzechiaSite Not Available
Clintrial S.R.O.
Praha 10, 100 00
CzechiaSite Not Available
Krajska Zdravotni A.S. - Masarykova Nemocnice V Usti Nad Labem O.Z.
Usti Nad Labem, 401 13
CzechiaSite Not Available
Klinikum Der Johann Wolfgang Goethe-Universitaet
Frankfurt, 60590
GermanySite Not Available
Derma-Study-Center Friedrichshafen Gmbh
Friedrichshafen, 88045
GermanySite Not Available
Dermatologikum Hamburg Gemeinschaftspraxis Gbr
Hamburg, 20354
GermanySite Not Available
Universitaetsklinikum Schleswig-Holstein
Kiel, 24105
GermanySite Not Available
Praxis Dr. Beate Schwarz
Langenau, 89129
GermanySite Not Available
Beldio Research Gmbh
Memmingen, 87700
GermanySite Not Available
Klifos - Klinische Forschung Osnabruck
Osnabruck, 49074
GermanySite Not Available
Klifos - Klinische Forschung Osnabruck
Osnabrã¼ck, 49074
GermanySite Not Available
Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. Z O.O.
Elblag, 82-300
PolandSite Not Available
Centrum Medyczne Angelius Provita
Katowice, 40-611
PolandSite Not Available
Centrum Medyczne Pratia Krakow
Krakow, 30-002
PolandSite Not Available
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin, 71-434
PolandSite Not Available
Etg Warszawa
Warszawa, 02-793
PolandSite Not Available
Dermmedica Sp. Z O.O.
Wroclaw, 51-318
PolandSite Not Available
Hospital General Universitario de Alicante
Alicante, 03010
SpainSite Not Available
Hospital de La Santa Creu I Sant Pau
Barcelona, 08041
SpainSite Not Available
Hospital General Universitario Gregorio Maranon
Madrid, 28007
SpainSite Not Available
Hospital de Manises
Manises, 46940
SpainSite Not Available
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcon, 28223
SpainSite Not Available
Southwest Skin Specialists Phoenix Biltmore
Phoenix, Arizona 85018
United StatesSite Not Available
Raoof Md Encino
Encino, California 91436
United StatesSite Not Available
First Oc Dermatology
Fountain Valley, California 92708
United StatesSite Not Available
Marvel Clinical Research Llc
Huntington Beach, California 92647
United StatesSite Not Available
Well Pharma Medical Research Corporation
Miami, Florida 33173
United StatesSite Not Available
Psoriasis Treatment Center of South Florida
Pembroke Pines, Florida 33028
United StatesSite Not Available
Lenus Research Medical Group, Llc
Sweetwater, Florida 33172
United StatesSite Not Available
Delricht Research
Marietta, Georgia 30060
United StatesSite Not Available
Arlington Dermatology
Rolling Meadows, Illinois 60008
United StatesSite Not Available
Midwest Allergy Sinus Asthma, Sc
Springfield, Illinois 62604
United StatesSite Not Available
Dermatologist Specialist
Louisville, Kentucky 40241
United StatesSite Not Available
Grafton Dermatology and Cosmetic Surgery
Houma, Louisiana 70364
United StatesSite Not Available
Delricht Research
New Orleans, Louisiana 70115
United StatesSite Not Available
Washington University
Saint Louis, Missouri 63110
United StatesSite Not Available
Jubilee Clinical Research Inc
Las Vegas, Nevada 89106
United StatesSite Not Available
Juva Skin and Laser Center
New York, New York 10022
United StatesSite Not Available
Oregon Health & Science University
Portland, Oregon 97239
United StatesSite Not Available
Oregon Medical Research Center
Portland, Oregon 97223
United StatesSite Not Available
Clinical Neuroscience Solutions Cns Healthcare Memphis Research Center
Memphis, Tennessee 38119
United StatesSite Not Available
International Clinical Research Tennessee Llc
Murfreesboro, Tennessee 37130
United StatesSite Not Available
Austin Institute For Clinical Research Aicr Pflugerville
Houston, Texas 77056
United StatesSite Not Available
Progressive Clinical Research
San Antonio, Texas 78213
United StatesSite Not Available
Center For Clinical Studies Webster
Webster, Texas 77598
United StatesSite Not Available
University of Utah
Murray, Utah 84107
United StatesSite Not Available
West End Dermatology Associates
Richmond, Virginia 23233
United StatesSite Not Available
Dermatology Specialists of Spokane
Spokane, Washington 99202
United StatesSite Not Available
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