Phase
Condition
Hand Dermatitis
Treatment
Vehicle
Ruxolitinib cream
Clinical 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 > 3 months 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 to treatment with topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), or oral alitretinoin; or intolerance or contraindication to TCS or TCI or oral alitretinoin.
- 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 previous patch tests) cannot be avoided during the course of this study.
- Participants who have an unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to baseline.
- Participants with concurrent conditions and history of other diseases such as other active skin disease or infection on the hands; immunocompromised; chronic or acute infection requiring systemic treatments; active acute skin infection; other concomitant skin conditions that may interfere with study assessments or compromise participant safety; other types of eczema; chronic asthma requiring high dose of inhaled corticosteroids; current or history of hepatitis B or C virus infection.
- Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant 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 before baseline.
- Psoralen ultraviolet A (PUVA) or ultraviolet B (UVB) therapy on the hands within 4 weeks before baseline.
- Pregnant or lactating participants, or those considering pregnancy during the period of their study participation.
- Further exclusion criteria apply.
Study Design
Study Description
Connect with a study center
CCA MEDICAL RESEARCH
Ajax, Ontario L1S 7K8
CanadaActive - Recruiting
LYNDERM RESEARCH INC
Markham, Ontario L3P 1X3
CanadaActive - Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
SpainActive - Recruiting
Hospital General Universitario Gregorio Maranon
Madrid, 28007
SpainActive - Recruiting
Hospital Universitario Quironsalud Madrid
Pozuelo De Alarcón, 28233
SpainActive - Recruiting
FIRST OC DERMATOLOGY
FOUNTAIN VALLEY, California 92708
United StatesActive - Recruiting
DelRicht Research
New Orleans, Louisiana 70115
United StatesActive - Recruiting
Washington University
Saint Louis, Missouri 63110
United StatesActive - Recruiting
JUVA Skin and Laser Center
New York, New York 10022
United StatesActive - Recruiting
Oregon Health & Science University
Portland, Oregon 97239
United StatesActive - Recruiting
INTERNATIONAL CLINICAL RESEARCH TENNESSEE LLC
MURFREESBORO, Tennessee 37130
United StatesActive - Recruiting
DERMATOLOGY SPECIALISTS OF SPOKANE
SPOKANE, Washington 99202
United StatesActive - Recruiting
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