Dermatitis, AtopicNCT01447381
Systemic Therapies for Pediatric Atopic Dermatitis
An observational study of Dermatitis, Atopic, run by Rady Children's Hospital, San Diego at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Dermatitis, Atopic
- How many people
- 250 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2011to Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
Children's Memorial Hospital
Chicago, Illinois, 60614
Duri Yun, MD, 312-227-6485, dyun@childrensmemorial.org
Katherine Mercy, MD, 312-227-6484, kmercy@childrensmemorial.org
- Recruiting
Rady Children's Hospital
San Diego, California, 92123
Wynnis Tom, MD, wtom@rchsd.org
Lawrence Eichenfield, MD, leichenfield@rchsd.org
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Kelly M. Cordoro, MD, 415-353-7800, cordorok@derm.ucsf.edu
Kelly M. Cordoro, MD
About this study
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.
Read the 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.
- Conditions
- Dermatitis, Atopic
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Investigator Global Severity Scale (IGSS)
Measured: 10 years
Reduction in SCORing Atopic Dermatitis (SCORAD) Index
Measured: 10 years
Reduction in Eczema Area and Severity Index (EASI)
Measured: 10 years
Secondary outcomes (3)
Time to Response
Measured: 10 years
Rate of Taper
Measuring the rate of dose descalation of systemic immunosuppresive without increase in atopic dermatitis severity as measured by IGSS, SCORAD and EASI assessments.
Measured: 10 years
Length of time before recurrent flare
Durability of response is the measure of time before recurrent flare after discontinuation of systemic immunosuppressive therapy.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionJul 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dermatitis, AtopicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rady Children's Hospital, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Diego
- Responsible party
- Principal investigator, Wynnis Tom, MD, Rady Children's Hospital, San Diego
- Investigators
- Wynnis Tom, MD, Principal investigator, Rady Children's Hospital and UC San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01447381
- Sponsor's protocol ID
- CMH 2011-14488
- Status last verified
- Nov 2012
- First submitted
- 11 Aug 2011
- Last updated
- 5 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 12423430Akhavan 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.
PubMed 12781440
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Therapies for Pediatric Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT01447381
- Acronym / sponsor ID
- CMH 2011-14488
- Conditions
- Dermatitis, Atopic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Rady Children's Hospital, San DiegoUniversity, hospital or other
- Collaborators
- University of California, San Diego
- Study start
- Oct 2011
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 6 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (11 listed)
- 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:
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
Time to Response
Time frame: 10 years
Rate of Taper
Time frame: 10 years
Length of time before recurrent flare
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2012.
- Background: PubMed 12423430Meagher 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.
- Background: PubMed 12781440Akhavan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wynnis Tom, MD principal investigator
Rady Children's Hospital and UC San Diego
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dermatitis, Atopic, run by Rady Children's Hospital, San Diego at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lori Murphy, BS, CCRP (858-576-1700 ext. 5210, lmurphy@rchsd.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Investigator Global Severity Scale (IGSS) (time frame: 10 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01447381, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2012.