the update trial (uvb phototherapy in dermatology for atopic eczema)

Conditions: Atopic Dermatitis Eczema; Atopic Dermatitis

Summary: the goal of this randomized controlled trial is to study the (cost)effectiveness of nb-uvb phototherapy in patients with atopic eczema/atopic dermatitis. half of the participants will undergo a course of nb-uvb phototherapy of 8-16 weeks and apply optimal topical therapy (ott) for a minimum of 3 months. researchers will compare the outcomes of this group with the other half of participants that apply ott only.

atopic eczema (ae) is a chronic fluctuating dermatological disease characterized by a pruritic inflammation of the skin. the condition poses a high global (financial) burden. one of the therapeutic options of ae is phototherapy, with narrowband uvb (nb-uvb) being the most common. the evidence of the (cost-)effectiveness of nb-uvb, however, is scarce and of low quality. the objective of this pragmatic multicenter single blinded randomized controlled trial is comparing the effectiveness and cost-effectiveness of narrowband ultraviolet b with optimal topical therapy (nb-uvb+ott) versus ott at 3 months in adult patients with insufficient control of their ae with standard topical treatment, for whom dermatologist and patient jointly believe that nb-uvb or ott is needed. participants that are randomized into the nb-uvb+ott group will receive an nb-uvb course (at home or at the outpatient clinic) for at least 8 and up to 16 weeks, combined with ott for at least 3 months. participants in the control group (ott group) will apply ott for at least 3 months. visits will occur at baseline and 1-3-6-9-12 months after start. at baseline, patient information is collected including an evaluation of medical history and a physical examination to assess fitzpatrick skin type and physician-reported clinical signs. during each visit patients are asked to fill out questionnaires. risks are expected to be as in daily practice. primary study parameters/outcome of the study is the percentage of patients with easi50 (a decrease of the eczema area and severity index of 50%) at 3 month follow-up. secondary study parameters/outcome of the study include delta easi, physician-reported clinical signs, patient-reported symptoms, quality of life, long-term control, cost-effectiveness, side effects at 1-3-6-9-12 months, quantity and potency topical steroid usage, time to starting systemic therapy, patient satisfaction with received treatment, percentage of patients reaching treatment target goals and percentage of drop-outs with reasons at 3-6-9-12 months.

Eligibility 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: * contra-indication for nb-uvb; * genetic defects associated with photosensitivity or skin cancer; * heavily photo-damaged skin; * history of multiple (\>1) skin malignancies; * use of systemic immunosuppressants/immunomodulators; * 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.

Keywords: atopic eczema atopic dermatitis nb-uvb phototherapy optimal topical therapy