Phase
Condition
Eczema (Atopic Dermatitis - Pediatric)
Atopic Dermatitis
Eczema (Atopic Dermatitis)
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Must understand and voluntarily sign an informed consent form
Must be male or female and aged ≥ 18 years at time of consent
Must be able to adhere to the study visit schedule and other protocol requirements
Must have a diagnosis of prurigo nodularis based on clinical and histological findingsand have failed four weeks of treatment with topical therapies, includingcorticosteroids and/or vitamin D derivatives.
Must meet the following laboratory criteria:
Hemoglobin WNL
Hematocrit WNL
White blood cell (WBC) count WNL
Neutrophils ≥ 1500 /dL
Platelets ≥ 100,000 /dL
Serum creatinine ≤ 1.5 mg/dL
Total bilirubin 2.0 mg/dL
Aspartate transaminase (AST [serum glutamic oxaloacetic transaminase, SGOT]) andalanine transaminase (ALT [serum glutamate pyruvic transaminase, SGPT]) 1.5xupper limit of normal (ULN)
Females of childbearing potential (FCBP) must have a negative urine pregnancy test atscreening (Visit Must have a negative purified protein derivative (PPD) within 28 daysof the baseline visit.
Must have a negative purified protein derivative (PPD) within 28 days of the baselinevisit.
Exclusion
Exclusion Criteria:
History of cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic,renal, hematologic, immunologic, or other major diseases deemed clinically significantby the investigator
Any systemic treatment (including ultraviolet light, corticosteroids, thalidomide,azathioprine, cyclosporine) within 28 days of study drug administration.
Any topical treatments (including corticosteroids, vitamin D derivatives) within 14days of study drug initiation.
Any condition, including the presence of laboratory abnormalities, which places thesubject at unacceptable risk if he/she were to participate in the study or confoundsthe ability to interpret data from the study.
Pregnant or lactating female.
Study Design
Connect with a study center
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United StatesSite Not Available

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