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:
2025-12-26 @ 2:42 PM
Ignite Modification Date:
2025-12-26 @ 2:42 PM
NCT ID:
NCT03795506
Eligibility Criteria:
Inclusion Criteria:
* Age 4 to 16 years at time of consent
* Persistent moderate to severe eczema despite treatment with topical corticosteroids (TCS) Class II or more and/or topical calcineurin inhibitors (TCI, licenced use only) for at least 3 months.
* Eczema Area and Severity Index (EASI) Score ≥12 at screening and randomisation visit and \>10% body surface involved
* Sensitisation to house dust mite species, confirmed by specific Immunoglobulin E (ImmunoCAP ≥2) and/or Skin Prick Test (SPT ≥5mm)
* Child able to sleep in their own bed and able to use the device for at least 5 out of 7 nights per week
* Written, informed consent of parent/legal guardian and patient assent
Exclusion Criteria:
* very severe atopic dermatitis
* use of systemic immunosuppression (such as cyclosporine, methotrexate, azathioprine, oral steroids) or UV therapy or extracorporal photopheresis within four weeks prior to the screening visit
* received therapeutic monoclonal antibodies (such as Omalizumab or Dupilumab) within six months prior to the screening visit
* Ongoing or planned desensitisation / immunotherapy during the study
* Infections requiring systemic antimicrobial treatment within four weeks prior to the screening visit
* Introduction of special dietary restriction (for eczema treatment) within three months prior to screening visit
* Severe asthma ≥ Step 4 and/or ≥1 course of systemic oral steroids for asthma in the three months prior to screening visit
* Significant underlying chronic medical condition (chronic other skin disease, inflammatory bowel disease, immunodeficiencies, other uncontrolled systemic disease, cancer)
* Planned time away from home (=unable to use TLA) exceeding 2 days/week; unable to use the device at least 5/7 days in the 2-3 weeks prior to end of intervention period.
* Prior research participation is not an exclusion criterion, except if it involved eczema disease modifying agents.
* Participating in current research
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
16 Years
Study:
NCT03795506
Study Brief:
Protocol Section:
NCT03795506