Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2025-12-24 @ 9:30 PM
NCT ID:
NCT03038932
Eligibility Criteria:
Inclusion Criteria:
1. Must be a participant already enrolled in the ADRN Registry and provided DNA (ClinicalTrials.gov ID: NCT01494142);
2. Participant and/or parent guardian must be able to understand and provide informed consent;
3. A history of Atopic Dermatitis (AD) with a history of eczema herpeticum (ADEH+), as diagnosed using the Atopic Dermatitis Research Network (ADRN) Standard Diagnostic Criteria, with ≥3 episodes of Eczema Herpeticum (EH)
OR
A history of AD without a history of eczema herpeticum (ADEH-), as diagnosed using the ADRN Standard Diagnostic Criteria, and no immediate family members (mother, father, full siblings, half-siblings, offspring, aunts, uncles, cousins, or grandparents) with a history of EH
OR
Non-atopic as diagnosed using the ADRN Standard Diagnostic Criteria.
4. Anti-Herpes Simplex Virus (HSV)-1 or Anti-HSV-2 Immunoglobulin G (IgG) seropositive.
Exclusion Criteria:
1. Inability or unwillingness of a participant and/or parent guardian to give written informed consent or comply with study protocol;
2. Pregnant or lactating women;
3. Known or suspected immunosuppression;
4. Severe concomitant illness(es);
5. History of keloid formation (adults only);
6. History of lidocaine or Novocain allergy (adults only);
7. History of serious life-threatening reaction to latex, tape, or adhesives;
8. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
9. Use of biologics within 5 half-lives (if known) or 16 weeks of the Screening Visit;
10. Use of an investigational drug within 5 half-lives (if known) or 8 weeks of the Screening Visit.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
64 Years
Study:
NCT03038932
Study Brief:
Protocol Section:
NCT03038932