Phase
Condition
Eczema (Atopic Dermatitis - Pediatric)
Skin Wounds
Allergy
Treatment
BxC-I17e
Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients (males or females) aged 18 years or older.
Patients have documented history of moderate to severe AD, that has been present forat least 1 year
History of inadequate response to a stable regimen of TCSs or TCIs as treatment forAD
Patients must agree to apply stable doses of additive-free, basic bland emollientlotions twice daily for at least 7 days before the Baseline Visit.
Willingness and ability to comply with clinic visits and study-related procedures.
Patients should be able to read, understand, and be willing to sign the ICF
Exclusion
Exclusion Criteria:
- Presence of any of the following laboratory abnormalities
Hemoglobin < 11 g/dL
WBC < 3.5 × 103/μL
Platelet count < 125 × 103/μL
Neutrophils < 1.75 × 103/μL
AST/ALT > 1.5 × ULN
Total bilirubin > ULN
Creatinine > ULN
Creatine phosphokinase > ULN
Positive test for hepatitis B surface antigen, and/or hepatitis C antibody
Active dermatologic conditions that may confound the diagnosis of AD
Prior exposure to any investigational systemic treatment or is currently enrolled inanother clinical study
Significant concomitant illness or history of significant illness such as cardiac,renal, neurological, endocrinological, metabolic or lymphatic disease, or any otherillness or condition that would adversely affect the patient's participation in thisstudy
Treatment with TCS, and/or TCI, within 1 week prior to the Baseline Visit.
Known history of human immunodeficiency virus (HIV) infection
Pregnant or breastfeeding women
Study Design
Connect with a study center
Arkansas Research Trials
North Little Rock, Arkansas 72117
United StatesActive - Recruiting
DermDox Centers for Dermatology
Camp Hill, Pennsylvania 17011
United StatesActive - Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
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