atopic dermatitis atopic eczema
Conditions
Interventions
A NB-UVB course (home or outpatient) for at least 8 and up to 16 weeks,
combined with OTT for at least 3 months, versus OTT alone
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Adult (>=18 years of age) patient meeting the UK working party criteria for atopic eczema; - AE insufficiently controlled by standard topical care and therefore eligible for NB-UVB or OTT; - Investigator Global Assessment (IGA, 0-4) of >= 2 (moderate disease); - Eczema Area and Severity Index (EASI) of >= 7 (moderate disease); - Understood and voluntarily signed and dated an informed consent form prior to any study-related procedure or has a legal representative who has, and is willing to comply with the study*s requirements.
Exclusion criteria
Exclusion criteria: - Contra-indication for NB-UVB; o Genetic defects associated with photosensitivity or skin cancer; o Heavily photo-damaged skin; o History of multiple (>1) skin malignancies; o Use of systemic immunosuppressants/immunomodulators; o Use of medication associated with photosensitivity; - Patient is already on systemic AE therapy; - Patient is already on OTT in the past 2 months; - NB-UVB or any systemic therapy in the past 9 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measure: % patients with EASI50 (Eczema Area and Severity Index) at 3 month follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures: Delta EASI, physician-reported clinical signs, patient-reported symptoms, quality of life, long-term control, cost-effectiveness and side effects at 1-3-6-9-12 months. Quantity and potency topical steroid usage, time to starting systemic therapy and patient satisfaction with received treatment. % patients reaching Treatment Target[1] goals and % drop-outs with reasons at 3-6-9-12 months. | — |
Countries
Netherlands
Outcome results
None listed