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Clinical Trial Details for Systemic Therapies for Pediatric Atopic Dermatitis


Rady Children's Hospital, San Diego
NCT ID: NCT01447381
Last Updated: November 1, 2012

The Study at a Glance

  • Status: Recruiting
  • Phase:
  • Gender: All
  • Age: 2 Years - 17 Years
  • Condition: Dermatitis, Atopic
  • Study Type: Observational
  • Intervention:
  • Lead Sponsor: Rady Children's Hospital, San Diego
  • Location: Not Provided

Official Title

Systemic Therapies for Pediatric Atopic Dermatitis

Purpose

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.

Eligibility

Ages Eligible for Study

2 Years to 17 Years

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Study Population

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.

Criteria

Inclusion Criteria:

– 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),
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:

– 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
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.

Additional Information, Locations & Contacts

Sponsors & Collaborators

Rady Children's Hospital, San Diego

University of California, San Diego

Investigators

Principal Investigator: Wynnis Tom, MD

Rady Children's Hospital and UC San Diego

Please refer to this study by its ClinicalTrials.gov identifier: NCT01447381

Location

Contacts

Rady Children's Hospital

San Diego, California 92123

United States

Wynnis Tom, MD

wtom@rchsd.org

University of California, San Francisco

San Francisco, California 94143

United States

Kelly M. Cordoro, MD

cordorok@derm.ucsf.edu

Children's Memorial Hospital

Chicago, Illinois 60614

United States