| City: |
|
Bethesda |
|
State:
|
|
MD |
| Zip Code: |
|
20892 |
| Conditions: |
|
Atopic Dermatitis - Netheron's Syndrome - Piebaldism - Hyper IgE Syndrome - Ichthyosis - Anaphylaxis - Severe Allergy |
| Purpose: |
|
Background:
- Allergic inflammation is central to allergy-related diseases and disorders, such as
asthma, food allergies, and atopic dermatitis. Atopic dermatitis, commonly called eczema
is a chronic, noncontagious skin condition, usually starting in the first years of life,
which causes itching and scaling of an individual's skin. Because atopic dermatitis is a
common condition in children who have allergy-related diseases, including asthma,
researchers are interested in studying both individuals with atopic dermatitis and their
close relatives (parents and children) to better understand how allergy-related diseases
develop and progress. In addition, some patients with inherited disorders with features
including atopic dermatitis or other aspects of allergy-such as food allergy, asthma, hay
fever, hives, and others, will also be seen.
Objectives:
- To study the natural history of diseases of allergic inflammation, such as atopic
dermatitis or genetic disorders associated with allergic inflammation.
Eligibility:
- Children and adolescents between 1 month and 21 years of age who have a documented
history of moderate to severe atopic dermatitis.
- Individuals between 1 month and 80 years of age who have a suspected genetic or
inherited allergy disorder related to atopic dermatitis or allergic pathways.
- Child and adult relatives of eligible participants will also be studied on this
protocol.
Design:
- The study will require one initial visit to the National Institutes of Health Clinical
Center (lasting 1-5 days), as well as any required follow-up visits for treatment and
research studies. Participants will receive treatment for atopic dermatitis and other
allergic diseases as part of the study for up to 1 year.
- Participants will have some or all of the following tests as part of this study:
- A detailed physical examination and medical history
- Allergy skin prick testing to examine participants' responses to different allergens.
- Blood samples for additional allergen testing, testing the immune system, and other
research purposes
- Skin punch biopsy to take a skin sample
- Lung function tests to measure airflow from the lungs and inflammation
- Food-related tests to diagnose potential food allergies
- Leukapheresis to collect white blood cells only
- Research samples, including stool specimens, saliva samples, buccal swabs (to collect
cells from the inside of the cheek), and skin cell sample...
|
| Study summary: |
|
Background:
Allergic inflammation is central to the pathogenesis of allergic diseases, including atopic
dermatitis, asthma, allergic rhinitis, and food allergy. These disorders are common,
affecting up to 50 million Americans, and their pathophysiology remains poorly understood.
Among allergic diseases, atopic dermatitis is common, with a prevalence of up to 20% in
children, is associated with the most dramatic elevations of IgE levels and most prominent
T-helper type 2 cell (Th2) inflammation, and treatment remains challenging. Atopic
dermatitis is also the first manifestation of allergic disease in many children, making it
an ideal disorder for studying the mechanisms of development and progression of allergic
diseases. In addition to atopic dermatitis, there are also a number of genetic and
congenital diseases, most presenting in childhood, that have prominent allergic
manifestations, including dermatitis, or affect atopic pathways. These disorders provide
further opportunity for advancing our understanding of the genetics and pathophysiology of
diseases of allergic inflammation. The NIAID Laboratory of Allergic Diseases (LAD) has a
long interest in exploring the mechanisms of allergic inflammation. Utilizing the resources
of the LAD and the NIH Clinical Center, we will advance our understanding of allergic
inflammation and the genetics and pathogenesis of allergic diseases through the study of
these patients. The findings of this protocol will have implications for improved
diagnosis, treatment and prevention of allergic diseases, including atopic asthma.
Objectives:
The overall goal of this exploratory protocol is to study the natural history of diseases of
allergic inflammation, focusing on subjects with moderate to severe atopic dermatitis or
with suspected genetic or congenital disorders associated with allergic inflammation.
Research studies obtained from blood, skin, stool, saliva, and other tests obtained from
participants, and affected or unaffected relatives, will be used to explore the genetic,
immunologic, structural, and microbiologic abnormalities of these diseases. Results of
research studies will be correlated with clinical features of allergic manifestations of
disease and response to therapy.
Eligibility:
Subjects eligible for enrollment in this study include children with moderate to severe
atopic dermatitis or children and adults with a suspected genetic or congenital disorder
associated with atopy or affecting an atopic pathway. Relatives of an enrolled subject (both
children and adults) will also be eligible for separate enrollment.
Design:
The initial enrollment for this protocol will be 300 primary subjects over 5 years. In
addition, approximately 300 healthy or affected parents, siblings, or other relatives may be
enrolled for initial history and clinical and research laboratory evaluation only.
Participants in this study will receive standard care for allergic diseases, both outpatient
and inpatient, during the period of enrollment and will receive extensive evaluation as
clinically indicated, in addition to research studies. |
| Criteria: |
|
- INCLUSION CRITERIA:
1. Subject must:
1. be at least 1 month of age and less than or equal to 21 years of age at the
time of enrollment and have documented history of AD, by modified Hanifin
and Rajka criteria, that began in the first 5 years of life, that is
moderate to severe, and with continued active flares in the preceding 3
months. Patients greater than 21 years of age with active moderate to
severe AD may be enrolled, at the discretion of the PI or AIs, if they have
a history of AD in the first 5 years of life or, if in the opinion of the
PI or AIs, the patient would be of interest to fulfill the objectives of
the study.
OR
2. be one month- 80 years of age with a suspected genetic or congenital
disorder associated with atopy or affecting an atopic pathway, as
determined by the PI or AIs.
OR
3. be a relative of a subject enrolled in the protocol.
2. have a private physician to provide local continuity of care.
3. provide a letter of referral, with copies of pertinent medical history and
laboratory studies, from prospective study participant's referring physician.
4. be willing to provide informed consent/assent and/or have a parent/guardian
willing to provide informed consent.
5. be willing to donate blood, stool, buccal swabs, saliva, skin and nasal swabs
for research and clinical studies and for storage to be used for future
research.
EXCLUSION CRITERIA:
1. Presence of conditions that, in the judgment of the investigator or the referring
physician, may put the subject at undue risk or make them unsuitable for
participation in the study.
2. Inability to provide informed consent.
3. Inability or refusal to undergo study procedures.
4. Inability to participate for the duration of the study. |
|
|
|
| Study is available at: |
|
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, MD 20892
United States
Primary Contact:
Patient Recruitment and Public Liaison Office
Email: prpl@mail.cc.nih.gov
Phone: (800) 411-1222 |
|
|
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
|
| Trials Alerts: |
|
If you would like to be
notified of new clinical trials as they become available please
register for a free account.
|
|
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
March 23, 2011 |
Modifications to
this listing: |
|
Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
|
|
|
|
|
|
|
|