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Systemic Therapies for Pediatric Atopic Dermatitis
While many patients with atopic dermatitis (eczema) can be managed with topical creams and treatments for itch, some children have such severe, long-standing disease that they need treatment with oral medications that decrease the ability of the immune system to react. However, there is not enough information on the proper use of these medications or how well they work compared with each other. The current study looks at the response of children treated with these medications to provide this information and improve their use.
2 Years to 17 Years
Ages 2 to 17 (inclusive) with moderate to severe atopic dermatitis and who require
treatment with cyclosporine, azathioprine, mycophenolate mofetil, and/or methotrexate. Both
male and female. Non-pregnant females and minorities will be included without restriction.
– Diagnosis of moderate, severe, or very severe atopic dermatitis meeting the Hanifin
and Rajka 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),
– 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
– Prior failure or need for more than one course of another oral immunosuppressive
– 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.
– Female who is pregnant, nursing, or planning a pregnancy during the study period.
– 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
– 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.
Rady Children's Hospital, San Diego
University of California, San Diego
Principal Investigator: Wynnis Tom, MD
Rady Children's Hospital and UC San Diego
Please refer to this study by its ClinicalTrials.gov identifier: NCT01447381
Rady Children's Hospital
San Diego, California 92123
Wynnis Tom, MDwtom@rchsd.org
University of California, San Francisco
San Francisco, California 94143
Kelly M. Cordoro, MDcordorok@derm.ucsf.edu
Children's Memorial Hospital
Chicago, Illinois 60614
Duri Yun, MDdyun@childrensmemorial.org