Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
250 participants
OBSERVATIONAL
2011-10-31
2021-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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mycophenolate mofetil
Moderate to severe atopic dermatitis being treated with systemic mycophenolate mofetil
No interventions assigned to this group
cyclosporine
Moderate to severe atopic dermatitis being treated with systemic cyclosporine
No interventions assigned to this group
azathioprine
Moderate to severe atopic dermatitis being treated with systemic azathioprine
No interventions assigned to this group
methotrexate
Moderate to severe atopic dermatitis being treated with systemic methotrexate
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Needs systemic therapy (e.g. cyclosporine, azathioprine, mycophenolate mofetil, or methotrexate) for severe atopic dermatitis
* Subject has severe or recalcitrant disease interrupting daily life as evidenced by fulfilling 2 or more of the following 4 criteria:
* Failure of multimodal therapy including emollients/barrier repair, topical anti-inflammatory agents (medium to high potency topical corticosteroids, and/or low-potency or topical calcineurin inhibitors if facial/intertriginous areas), and antihistamines
* Significant impairment in quality of life (physical, psychological, emotional) such as significant sleep disruption, poor school performance, or frequent school absenteeism, per the judgement of the investigator.
* Inability to receive, prior failure, or the need for more than one course of phototherapy
* Prior failure or need for more than one course of another oral immunosuppressive medication
* No serious medical condition that precludes the use of oral immunosuppressives based on the subject's medical history, physical examination, and safety laboratory tests.
* Negative PPD within the last year prior to study initiation.
* Female of childbearing potential has a negative pregnancy test at the time of starting the systemic drug and who consents to be abstinent or using an effective method of contraception during the study. Effective contraception is defined as IUD, condom with spermicide, diaphragm with spermicide, or stable use of a hormonal contraceptive (oral, implant, injection or transdermal patch) beginning at least 1 month prior to starting the systemic drug.
* Subject and parent/guardian are willing and able to comply with study instructions and return to the clinic for all required visits.
Exclusion Criteria
* Concurrent participation in another clinical trial with an investigational drug or device that may impact on the individual's atopic dermatitis.
* Subjects with clinically significant hepatic disease, history of lymphoma or myelosuppression, low TMPT activity (if starting azathioprine), renal disease (if starting cyclosporine or azathioprine), hypertension (if starting cyclosporine), blood dyscrasias, or central nervous system disorders, such as uncontrolled seizures or peripheral neuropathy, or taking systemic medications that could interact adversely with the study medicine (e.g. erythromycin use with cyclosporine).
* Subjects with any underlying disease that the Investigator deems uncontrolled, and poses a concern for subject safety while participating on the study.
* Subject has a history of clinically significant drug or alcohol abuse in the last year.
* Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
* Active systemic infection that could worsen with systemic therapy for AD.
2 Years
17 Years
ALL
No
Sponsors
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University of California, San Diego
OTHER
Rady Children's Hospital, San Diego
OTHER
Responsible Party
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Wynnis Tom, MD
Assistant Clinical Professor
Principal Investigators
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Wynnis Tom, MD
Role: PRINCIPAL_INVESTIGATOR
Rady Children's Hospital and UC San Diego
Locations
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Rady Children's Hospital
San Diego, California, United States
University of California, San Francisco
San Francisco, California, United States
Children's Memorial Hospital
Chicago, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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Wynnis Tom, MD
Role: primary
Lawrence Eichenfield, MD
Role: backup
Kelly M. Cordoro, MD
Role: primary
Duri Yun, MD
Role: primary
Katherine Mercy, MD
Role: backup
References
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Meagher LJ, Wines NY, Cooper AJ. Atopic dermatitis: review of immunopathogenesis and advances in immunosuppressive therapy. Australas J Dermatol. 2002 Nov;43(4):247-54. doi: 10.1046/j.1440-0960.2002.00610.x.
Akhavan A, Rudikoff D. The treatment of atopic dermatitis with systemic immunosuppressive agents. Clin Dermatol. 2003 May-Jun;21(3):225-40. doi: 10.1016/s0738-081x(02)00362-0. No abstract available.
Other Identifiers
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CMH 2011-14488
Identifier Type: -
Identifier Source: org_study_id