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Systemic Therapies for Pediatric Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01447381
Recruitment Status : Recruiting
First Posted : October 6, 2011
Last Update Posted : November 4, 2012
University of California, San Diego
Information provided by (Responsible Party):
Wynnis Tom, MD, Rady Children's Hospital, San Diego

Brief Summary:
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.

Condition or disease
Dermatitis, Atopic

Detailed Description:
Severe and/or refractory cases of atopic dermatitis (AD) can require systemic immunosuppressive therapy for disease control, yet there are few studies regarding the appropriate use of these drugs for pediatric AD and even less data comparing them. The current observational study will observe the effect of these therapies on children with moderate to severe atopic dermatitis as they are treated. These drugs being observed will be cyclosporine, azathioprine, mycophenolate mofetil, and methotrexate.

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Systemic Therapies for Pediatric Atopic Dermatitis
Study Start Date : October 2011
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

mycophenolate mofetil
Moderate to severe atopic dermatitis being treated with systemic mycophenolate mofetil
Moderate to severe atopic dermatitis being treated with systemic cyclosporine
Moderate to severe atopic dermatitis being treated with systemic azathioprine
Moderate to severe atopic dermatitis being treated with systemic methotrexate

Primary Outcome Measures :
  1. Reduction in Investigator Global Severity Scale (IGSS) [ Time Frame: 10 years ]
  2. Reduction in SCORing Atopic Dermatitis (SCORAD) Index [ Time Frame: 10 years ]
  3. Reduction in Eczema Area and Severity Index (EASI) [ Time Frame: 10 years ]

Secondary Outcome Measures :
  1. Time to Response [ Time Frame: 10 years ]
  2. Rate of Taper [ Time Frame: 10 years ]
    Measuring the rate of dose descalation of systemic immunosuppresive without increase in atopic dermatitis severity as measured by IGSS, SCORAD and EASI assessments.

  3. Length of time before recurrent flare [ Time Frame: 10 years ]
    Durability of response is the measure of time before recurrent flare after discontinuation of systemic immunosuppressive therapy.

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01447381

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Contact: Lori Murphy, BS, CCRP 858-576-1700 ext 5210

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United States, California
Rady Children's Hospital Recruiting
San Diego, California, United States, 92123
Contact: Wynnis Tom, MD   
Contact: Lawrence Eichenfield, MD   
Principal Investigator: Wynnis Tom, MD         
Principal Investigator: Lawrence Eichenfield, MD         
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Kelly M. Cordoro, MD    415-353-7800   
Principal Investigator: Kelly M. Cordoro, MD         
Principal Investigator: Ilona J. Frieden, MD         
Principal Investigator: Jeffrey Sugarman, MD         
United States, Illinois
Children's Memorial Hospital Recruiting
Chicago, Illinois, United States, 60614
Contact: Duri Yun, MD    312-227-6485   
Contact: Katherine Mercy, MD    312-227-6484   
Principal Investigator: Amy Paller, MD         
Sponsors and Collaborators
Rady Children's Hospital, San Diego
University of California, San Diego
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Principal Investigator: Wynnis Tom, MD Rady Children's Hospital and UC San Diego
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Responsible Party: Wynnis Tom, MD, Assistant Clinical Professor, Rady Children's Hospital, San Diego Identifier: NCT01447381    
Other Study ID Numbers: CMH 2011-14488
First Posted: October 6, 2011    Key Record Dates
Last Update Posted: November 4, 2012
Last Verified: November 2012
Additional relevant MeSH terms:
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Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases