Phase
Condition
Dermatitis, Atopic
Atopic Dermatitis
Allergy
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject has signed the informed consent form and Health Insurance Portability andAccountability Act (HIPAA) authorization form;
Male or female subject at least 12 years of age; subjects under 18 years of age willneed parental or official guardian consent.
A diagnosis of eczema with at least three lesions no larger than 7 by 7 cm on eitherthe trunk, arms, or legs that would serve as target lesions. The lesions must be wideenough apart so that there is no overlap of hydrogel patches. All three lesions musthave at least 5 out of 12 points on the modified EASI scale. Each of the three lesionsmust have no greater than 1 point difference from each other on the modified EASIscore. (If the subject can identify specific eczema lesions that are more pruritic,recalcitrant and/or tend to initiate the itch-scratch cycle, then those lesions willbe preferentially selected as the target lesions.)
Any additional diagnoses must, in the investigator's opinion, not preclude the subjectfrom safely participating in this study or interfere with the evaluation of thesubject's eczema;
Subject is able to completely discontinue the use of any medication or therapy (otherthan study medications) for relief of eczema in the target areas to be treated;
Subject is able to completely discontinue the use of any systemic medication ortherapy (e.g. oral medications, phototherapy, herbal remedies, or acupuncture) forrelief of eczema;
Subject must be reliable and mentally competent to complete study measurements;
Subject is able to understand and agrees to comply with study requirements, attendstudy visits, and comply with the restrictions during the study.
Exclusion
Exclusion Criteria:
Subjects with exclusively hand, face, foot, and/or groin dermatitis
Known hypersensitivity to any component of the test medications;
Pigmentation, extensive scarring, or pigmented lesions in affected areas that wouldinterfere with evaluation of efficacy parameters;
Clinically infected eczema at baseline.
Any evidence of atrophy in the areas selected for treatment with topicalcorticosteroid;
Subjects requiring any other medication (topical or systemic) that may affect thecourse of the disease during the study period (e.g. oral corticosteroids,immunosuppressants, antibiotics, sedating antihistamines). Inhaled steroids will bepermitted.
Topical therapies (other than non-prescription emollients) on potential target lesionswithin one week of starting study treatment;
Systemic therapy, phototherapy, or a systemic investigational therapy for eczemawithin 30 days prior to study entry;
Subject is considered unreliable as to medication compliance or adherence to scheduledappointments as determined by the investigators.
Study Design
Study Description
Connect with a study center
UCSF Psoriasis Skin and Treatment Center
San Francisco, California 94118
United StatesSite Not Available

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