Last updated: October 22, 2020
Sponsor: National Jewish Health
Overall Status: Active - Recruiting
Phase
N/A
Condition
Eczema (Atopic Dermatitis)
Allergy (Pediatric)
Eczema (Atopic Dermatitis - Pediatric)
Treatment
N/AClinical Study ID
NCT04606615
ADRN3-CRC
Ages 1-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male or female, 1 to 17 years of age inclusive at Screening for the pediatric group, 18-65 years of age for the adult group
- For all pediatric participants parent guardian must be able to understand and provideinformed consent and participant provide assent as applicable per Institutional ReviewBoard (IRB) guidelines and regulations
- Children: active AD and food allergy to peanut OR active AD and food allergy to milkOR active AD and food allergy to eggs. Adults: active AD and food allergy to peanut.Participant must meet all of the following criteria:
- Self-report or documentation of a positive oral food challenge to peanut OR eggOR milk or self-report of an allergic reaction to peanut OR egg OR milk within 2hours of ingestion
- Skin prick test wheal≥8mm for peanut, milk or egg OR
- Active AD and no food allergy. Participant must meet all of the followingcriteria:
- No personal history or current manifestations of food allergy (based on noself-report of a positive oral food challenge, positive skin test, positive bloodtest, or allergic reactions)
- Negative skin prick test (wheal<3mm) to peanut, milk, egg, wheat, soy, shellfishmix, treenuts, and sesame seed OR NA. Participant must meet all of the following criteria:
- No personal history or current manifestations of AD, asthma, or allergic rhinitis (based on self-report)
- No personal history or current manifestations of food allergy (based on no self-reportof a positive oral food challenge, positive skin test, positive blood test, orallergic reactions)
- Negative skin pricktest (wheal<3mm) to peanut, milk, egg, wheat, soy, shellfish mix,treenuts, and sesame seed
- Negative skin prick test(wheal<3mm) to environmental allergens (cat, dog, dustmite,cockroach, and local trees/grasses/weeds/molds)
Exclusion
Exclusion Criteria:
- Inability or unwillingness of a parent guardian (for pediatric participants) togive written informed consent, or participant to give assent, if applicable, or tocomply with study protocol 2. Who have any skin disease other than AD that mightcompromise the stratum corneum barrier (e.g., bullous diseases, psoriasis, cutaneous Tcell lymphoma [also called Mycosis Fungoides or Sezary syndrome], dermatitisherpetiformis, Hailey-Hailey, or Darier's disease).
- Pregnant or lactating females 4. Known or suspected immunosuppression 5. Severeconcomitant illness(es) 6. History of serious life-threatening reaction to latex,tape, or adhesives 7. Past or current medical problems or findings from physicalexamination or laboratory testing that are not listed above, which, in the opinion ofthe investigator, may pose additional risks from participation in the study, mayinterfere with the participant's ability to comply with study requirements or that mayimpact the quality or interpretation of the data obtained from the study 8. Use ofbiologics within 5 half-lives (if known) or 16 weeks of the Screening Visit 9. Use ofan investigational drug within 5 half-lives (if known) or 8 weeks of the ScreeningVisit 10. Has received immunotherapy within 12 months of the Screening Visit
Study Design
Total Participants: 160
Study Start date:
October 16, 2020
Estimated Completion Date:
December 31, 2022
Connect with a study center
National Jewish Health
Denver, Colorado 80206
United StatesActive - Recruiting
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