The UPDATE Trial (Uvb Phototherapy in Dermatology for ATopic Eczema)

Atopic Dermatitis Clinical Trial

— UPDATE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05704205
• Other study ID #: NL81882.018.22
• Status: Recruiting
• Phase: N/A
• Start date: February 22, 2023
• Est. completion date: December 2026

Study information

• Verified date: June 2023
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Prof. Phyllis I Spuls, MD PhD
• Phone: +3120 566 9111
• Email: ph.i.spuls[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 316
• Est. completion date: December 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Atopic Dermatitis Eczema
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Device:
• NB-UVB phototherapy
Narrowband ultraviolet B irradiation 3 times a week

Combination Product:
• Optimal topical therapy
A combination of detailed instructions about the disease and treatments by trained nurses, bathing and washing advices, adequate emollients use, avoidance of triggers (including possible and proven contact allergens), fingertip unit explanation for active topical therapy, and personalized topical therapy with different potency topical steroids, calcineurin inhibitors and tar ointments

Locations

Country	Name	City	State
Netherlands	Centrum Oosterwal	Alkmaar	Noord-Holland
Netherlands	Flevoziekenhuis	Almere	Flevoland
Netherlands	Meander Medisch Centrum	Amersfoort	Utrecht
Netherlands	Amsterdam Universitair Medische Centra	Amsterdam	Noord-Holland
Netherlands	Huid Medisch Centrum	Amsterdam	Noord-Holland
Netherlands	OLVG	Amsterdam	Noord-Holland
Netherlands	Reinier de Graaf Gasthuis	Delft	Zuid-Holland
Netherlands	Jeroen Bosch Ziekenhuis	Den Bosch	Noord-Brabant
Netherlands	Bergman Clinics	Haarlem	Noord-Holland
Netherlands	Spaarne Gasthuis	Hoofddorp	Noord-Holland
Netherlands	Medisch Centrum Leeuwarden	Leeuwarden	Friesland
Netherlands	Leids Universitair Medisch Centrum	Leiden	Zuid-Holland
Netherlands	Alrijne Ziekenhuis	Leiderdorp	Zuid-Holland
Netherlands	Dijklander Ziekenhuis	Purmerend	Noord-Holland
Netherlands	Erasmus Medisch Centrum	Rotterdam	Zuid-Holland
Netherlands	Isala Klinieken	Zwolle	Overijssel

Sponsors (2)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients that reach EASI50	Percentage of patients that reach a 50% reduction of the EASI (Eczema Area and Severity Index) at 3 month follow-up	3 months
Secondary	Delta EASI	Change in EASI (Eczema Area and Severity Index) at 3 month follow up	3 months
Secondary	Cost-effectiveness	Questionnaire-based calculation of medical consumption- and productivity costs in both arms	1 year
Secondary	Patient reported outcomes	Questionnaire-based review of quality of life, patient satisfaction	1 year
Secondary	Time to start systemic therapy	The time to start of systemic AE treatment in both arms	1 year
Secondary	Quantity of topical steroid usage	The amount of used topical corticosteroids in both groups	1 year
Secondary	Potency of topical steroid usage	The potency (I-IV) of used topical corticosteroids in both groups	1 year