Systemic Therapies for Pediatric Atopic Dermatitis

This study is currently recruiting participants.
Verified November 2012 by Rady Children's Hospital, San Diego
Sponsor:
Collaborator:
University of California, San Diego
Information provided by (Responsible Party):
Wynnis Tom, MD, Rady Children's Hospital, San Diego
ClinicalTrials.gov Identifier:
NCT01447381
First received: August 11, 2011
Last updated: November 1, 2012
Last verified: November 2012
  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.


Condition
Dermatitis, Atopic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Systemic Therapies for Pediatric Atopic Dermatitis

Resource links provided by NLM:


Further study details as provided by Rady Children's Hospital, San Diego:

Primary Outcome Measures:
  • Reduction in Investigator Global Severity Scale (IGSS) [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Reduction in SCORing Atopic Dermatitis (SCORAD) Index [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Reduction in Eczema Area and Severity Index (EASI) [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to Response [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Rate of Taper [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    Measuring the rate of dose descalation of systemic immunosuppresive without increase in atopic dermatitis severity as measured by IGSS, SCORAD and EASI assessments.

  • Length of time before recurrent flare [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    Durability of response is the measure of time before recurrent flare after discontinuation of systemic immunosuppressive therapy.


Estimated Enrollment: 250
Study Start Date: October 2011
Estimated Study Completion Date: July 2021
Estimated Primary Completion Date: July 2021 (Final data collection date for primary outcome measure)
Groups/Cohorts
mycophenolate mofetil
Moderate to severe atopic dermatitis being treated with systemic mycophenolate mofetil
cyclosporine
Moderate to severe atopic dermatitis being treated with systemic cyclosporine
azathioprine
Moderate to severe atopic dermatitis being treated with systemic azathioprine
methotrexate
Moderate to severe atopic dermatitis being treated with systemic methotrexate

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.

  Eligibility

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
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.

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

Contacts
Contact: Lori Murphy, BS, CCRP 858-576-1700 ext 5210 lmurphy@rchsd.org

Locations
United States, California
Rady Children's Hospital Recruiting
San Diego, California, United States, 92123
Contact: Wynnis Tom, MD       wtom@rchsd.org   
Contact: Lawrence Eichenfield, MD       leichenfield@rchsd.org   
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    cordorok@derm.ucsf.edu   
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    dyun@childrensmemorial.org   
Contact: Katherine Mercy, MD    312-227-6484    kmercy@childrensmemorial.org   
Principal Investigator: Amy Paller, MD         
Sponsors and 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
  More Information

Publications:
Responsible Party: Wynnis Tom, MD, Assistant Clinical Professor, Rady Children's Hospital, San Diego
ClinicalTrials.gov Identifier: NCT01447381     History of Changes
Other Study ID Numbers: CMH 2011-14488
Study First Received: August 11, 2011
Last Updated: November 1, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Dermatitis, Atopic
Dermatitis
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Azathioprine
Mycophenolate mofetil
Mycophenolic Acid
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antibiotics, Antineoplastic
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 23, 2014