TLA in Children With Moderate to Severe Atopic Eczema (TLA4AE)

Launched by IMPERIAL COLLEGE LONDON · Jan 4, 2019

Keywords

ClinConnect Summary

The TLA in Children With Moderate to Severe Atopic Eczema (TLA4AE) clinical trial is studying a new treatment for children aged 4 to 16 years who have moderate to severe eczema that hasn’t improved with standard treatments like creams or ointments. The trial aims to see if this new treatment can help reduce the symptoms of eczema in children who have been dealing with it for a long time. To participate, children must have a specific level of eczema severity and be sensitized to dust mites, which is a common allergen.

Participants in this study will be randomly assigned to receive either the new treatment or a placebo (a non-active treatment), and the trial will take place at one center. Parents or guardians will need to give their permission, and children will need to agree to participate as well. It’s important that participants can use the treatment device regularly at home and have a stable living situation, as they’ll need to use it consistently for the duration of the trial. Overall, this study hopes to find better ways to help children with challenging eczema manage their condition and improve their quality of life.

Gender

ALL

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