- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01447381
Systemic Therapies for Pediatric Atopic Dermatitis
November 1, 2012 updated by: Wynnis Tom, MD, Rady Children's Hospital, San Diego
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.
Study Overview
Status
Unknown
Conditions
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.
Study Type
Observational
Enrollment (Anticipated)
250
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lori Murphy, BS, CCRP
- Phone Number: 5210 858-576-1700
- Email: lmurphy@rchsd.org
Study Locations
-
-
California
-
San Diego, California, United States, 92123
- Recruiting
- Rady Children's Hospital
-
Contact:
- Wynnis Tom, MD
- Email: wtom@rchsd.org
-
Contact:
- Lawrence Eichenfield, MD
- Email: leichenfield@rchsd.org
-
Principal Investigator:
- Wynnis Tom, MD
-
Principal Investigator:
- Lawrence Eichenfield, MD
-
San Francisco, California, United States, 94143
- Recruiting
- University of California, San Francisco
-
Contact:
- Kelly M. Cordoro, MD
- Phone Number: 415-353-7800
- Email: cordorok@derm.ucsf.edu
-
Principal Investigator:
- Kelly M. Cordoro, MD
-
Principal Investigator:
- Ilona J. Frieden, MD
-
Principal Investigator:
- Jeffrey Sugarman, MD
-
-
Illinois
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Chicago, Illinois, United States, 60614
- Recruiting
- Children's Memorial Hospital
-
Contact:
- Duri Yun, MD
- Phone Number: 312-227-6485
- Email: dyun@childrensmemorial.org
-
Contact:
- Katherine Mercy, MD
- Phone Number: 312-227-6484
- Email: kmercy@childrensmemorial.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduction in Investigator Global Severity Scale (IGSS)
Time Frame: 10 years
|
10 years
|
Reduction in SCORing Atopic Dermatitis (SCORAD) Index
Time Frame: 10 years
|
10 years
|
Reduction in Eczema Area and Severity Index (EASI)
Time Frame: 10 years
|
10 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Response
Time Frame: 10 years
|
10 years
|
|
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.
|
10 years
|
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.
|
10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Wynnis Tom, MD, Rady Children's Hospital and UC San Diego
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (Anticipated)
July 1, 2021
Study Completion (Anticipated)
July 1, 2021
Study Registration Dates
First Submitted
August 11, 2011
First Submitted That Met QC Criteria
October 4, 2011
First Posted (Estimate)
October 6, 2011
Study Record Updates
Last Update Posted (Estimate)
November 4, 2012
Last Update Submitted That Met QC Criteria
November 1, 2012
Last Verified
November 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMH 2011-14488
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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