Phase
Condition
Allergy
Rash
Dermatitis, Atopic
Treatment
N/AClinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female patients 18-75 years of age
AD diagnosed by the Rajka/Hanifin criteria at the time of screening and that has beenpresent for at least 1 year
History of inadequate response to a stable regimen of TCS for 1 month (in the 3 monthsimmediately preceding the screening visit) as treatment for their AD
Eczema Area and Severity Index (EASI) score ≥ 14 at the screening and baseline visits
Investigator's Global Assessment (IGA; 5-point) score ≥ 3 at the screening andbaseline visits
≥10% body surface area involvement by AD
A washout period prior to screening for those patients who have previously receivedthe following medications:
Cyclosporine/Oral Steroids/Imuran/Mycophenolate Mofetil/Other systemicimmunosuppressants: 4 weeks
Phototherapy: 4 weeks
Biologics: 5 half lives of the drug
Exclusion
Exclusion Criteria:
Evidence of other concomitant skin conditions (e.g., psoriasis or contact dermatitis)
Use of topical calcineurin inhibitors within 4 weeks of screening
Hypersensitivity to TCS or to any other ingredients contained by the emollient or TCSproduct used during the study
Evidence of active skin infection at screening or baseline visit
Evidence or history of active or latent infections such as tuberculosis or hepatitis C
Patient clinical condition is not appropriate for treatment with protocol prescribedTCS
Use of an investigational agent within 4 weeks prior to screening or within 5half-lives of the investigational agent, whichever is longer
Use of a tanning booth/parlor within 4 weeks before the baseline visit
Use of any anti-histamine medication within 4 weeks before the baseline visit.
History of any condition (e.g. bleeding diathesis) that may predispose the patient tocomplications associated with the planned skin biopsy procedures
Known current malignancy or current evaluation for a potential malignancy, includingbasal or squamous cell carcinoma of the skin or carcinoma in situ
Other clinically significant medical disease that is uncontrolled despite treatmentthat is likely, in the opinion of the investigator, to impact the patient's ability toparticipate in the study or to impact the study pharmacodynamic (PD), or safetyassessments
Unwillingness or inability to comply with the study protocol for any other reason.
Study Design
Study Description
Connect with a study center
UCSF Dermatology
San Francisco, California 94115
United StatesSite Not Available

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