Recruiting

Systemic Therapies

Sponsor:

Rady Children's Hospital, San Diego

Code:

NCT01447381

Conditions

Dermatitis, Atopic

Eligibility Criteria

Sex: All

Age: 2 - 17

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Dermatitis, Atopic

Study ID

NCT01447381

Start date

Oct, 2011

Status verified date

Nov, 2012

Completion date

Jul, 2021

Anticipated

Primary completion date

Jul, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 17

Healthy Volunteers: Not accepted

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 Design

Enrollment

250 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Primary outcome measure

  • Reduction in Investigator Global Severity Scale (IGSS) [ Time Frame: 10 years ]
  • Reduction in SCORing Atopic Dermatitis (SCORAD) Index [ Time Frame: 10 years ]
  • Reduction in Eczema Area and Severity Index (EASI) [ Time Frame: 10 years ]

Central Contacts and Locations

Central contacts

Lori Murphy, BS, CCRP

858-576-1700lmurphy@rchsd.org

Locations

Rady Children's Hospital

Recruiting

San Diego, California, United States, 92123

Contacts

Wynnis Tom, MD

wtom@rchsd.org

Lawrence Eichenfield, MD

leichenfield@rchsd.org

Principal Investigator:

Wynnis Tom, MD

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Kelly M. Cordoro, MD

415-353-7800cordorok@derm.ucsf.edu

Principal Investigator:

Kelly M. Cordoro, MD

Children's Memorial Hospital

Recruiting

Chicago, Illinois, United States, 60614

Contacts

Duri Yun, MD

312-227-6485dyun@childrensmemorial.org

Katherine Mercy, MD

312-227-6484kmercy@childrensmemorial.org

Principal Investigator:

Amy Paller, MD

More Information

Sponsor

Rady Children's Hospital, San Diego

Last update posted

Nov 4, 2012

Last verified

Nov, 2012

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Rady Children's Hospital, San Diego on 2012-11-04.