The UPDATE Trial (Uvb Phototherapy in Dermatology for ATopic Eczema)
- Conditions
- Atopic Dermatitis EczemaAtopic Dermatitis
- Interventions
- Device: NB-UVB phototherapyCombination Product: Optimal topical therapy
- Registration Number
- NCT05704205
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 316
- 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.
-
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NB-UVB+OTT NB-UVB phototherapy 8-16 weeks of NB-UVB phototherapy combined with (a minimum of) 3 months of optimal topical therapy Optimal topical therapy (OTT) Optimal topical therapy (a minimum of) 3 months of optimal topical therapy NB-UVB+OTT Optimal topical therapy 8-16 weeks of NB-UVB phototherapy combined with (a minimum of) 3 months of optimal topical therapy
- Primary Outcome Measures
Name Time Method Percentage of patients that reach EASI50 3 months Percentage of patients that reach a 50% reduction of the EASI (Eczema Area and Severity Index) at 3 month follow-up
- Secondary Outcome Measures
Name Time Method Time to start systemic therapy 1 year The time to start of systemic AE treatment in both arms
Delta EASI 3 months Change in EASI (Eczema Area and Severity Index) at 3 month follow up
Cost-effectiveness 1 year Questionnaire-based calculation of medical consumption- and productivity costs in both arms
Patient reported outcomes 1 year Questionnaire-based review of quality of life, patient satisfaction
Quantity of topical steroid usage 1 year The amount of used topical corticosteroids in both groups
Potency of topical steroid usage 1 year The potency (I-IV) of used topical corticosteroids in both groups
Trial Locations
- Locations (16)
Dijklander Ziekenhuis
🇳🇱Purmerend, Noord-Holland, Netherlands
Flevoziekenhuis
🇳🇱Almere, Flevoland, Netherlands
Spaarne Gasthuis
🇳🇱Hoofddorp, Noord-Holland, Netherlands
Leids Universitair Medisch Centrum
🇳🇱Leiden, Zuid-Holland, Netherlands
OLVG
🇳🇱Amsterdam, Noord-Holland, Netherlands
Jeroen Bosch Ziekenhuis
🇳🇱Den Bosch, Noord-Brabant, Netherlands
Centrum Oosterwal
🇳🇱Alkmaar, Noord-Holland, Netherlands
Bergman Clinics
🇳🇱Haarlem, Noord-Holland, Netherlands
Amsterdam Universitair Medische Centra
🇳🇱Amsterdam, Noord-Holland, Netherlands
Huid Medisch Centrum
🇳🇱Amsterdam, Noord-Holland, Netherlands
Reinier de Graaf Gasthuis
🇳🇱Delft, Zuid-Holland, Netherlands
Alrijne Ziekenhuis
🇳🇱Leiderdorp, Zuid-Holland, Netherlands
Erasmus Medisch Centrum
🇳🇱Rotterdam, Zuid-Holland, Netherlands
Meander Medisch Centrum
🇳🇱Amersfoort, Utrecht, Netherlands
Isala Klinieken
🇳🇱Zwolle, Overijssel, Netherlands
Medisch Centrum Leeuwarden
🇳🇱Leeuwarden, Friesland, Netherlands