Clinical trial NCT05704205: The UPDATE Trial (Uvb Phototherapy in Dermatology for ATopic Eczema)
Official title: The UPDATE Trial (Uvb Phototherapy in Dermatology for ATopic Eczema): A Multicenter Randomized Controlled Trial of Narrowband UVB Versus Optimized Topical Therapy in Patients With Atopic Eczema
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atopic Dermatitis Eczema
Atopic Dermatitis
Keywords: atopic eczema
atopic dermatitis
NB-UVB
phototherapy
optimal topical therapy
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2023-01-30
Enrollment: 316
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percentage of patients that reach EASI50
timeFrame: 3 months
Secondary outcomes:
measure: Delta EASI
timeFrame: 3 months
measure: Cost-effectiveness
timeFrame: 1 year
measure: Patient reported outcomes
timeFrame: 1 year
measure: Time to start systemic therapy
timeFrame: 1 year
measure: Quantity of topical steroid usage
timeFrame: 1 year
measure: Potency of topical steroid usage
timeFrame: 1 year
Other outcomes:
Locations:
city: Almere
country: Netherlands
facility: Flevoziekenhuis
state: Flevoland
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
state: Friesland
city: Den Bosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
state: Noord-Brabant
city: Alkmaar
country: Netherlands
facility: Centrum Oosterwal
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: OLVG
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: Amsterdam Universitair Medische Centra
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: Huid Medisch Centrum
state: Noord-Holland
city: Haarlem
country: Netherlands
facility: Bergman Clinics
state: Noord-Holland
city: Hoofddorp
country: Netherlands
facility: Spaarne Gasthuis
state: Noord-Holland
city: Purmerend
country: Netherlands
facility: Dijklander Ziekenhuis
state: Noord-Holland
city: Zwolle
country: Netherlands
facility: Isala Klinieken
state: Overijssel
city: Amersfoort
country: Netherlands
facility: Meander Medisch Centrum
state: Utrecht
city: Delft
country: Netherlands
facility: Reinier de Graaf Gasthuis
state: Zuid-Holland
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum
state: Zuid-Holland
city: Leiderdorp
country: Netherlands
facility: Alrijne Ziekenhuis
state: Zuid-Holland
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
state: Zuid-Holland
Study officials:
affiliation: Amsterdam University Medical Centers
name: Louise AA Gerbens, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: