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

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status: Active, not recruiting

Conditions: Atopic Dermatitis; Atopic Dermatitis Eczema

Treatments: Device: NB-UVB phototherapy; Combination Product: Optimal topical therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05704205

NL81882.018.22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 316 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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316 participants in 2 patient groups

NB-UVB+OTT

Experimental group

Description:

8-16 weeks of NB-UVB phototherapy combined with (a minimum of) 3 months of optimal topical therapy

Treatment:

Combination Product: Optimal topical therapy

Device: NB-UVB phototherapy

Optimal topical therapy (OTT)

Active Comparator group

Description:

(a minimum of) 3 months of optimal topical therapy

Treatment:

Combination Product: Optimal topical therapy