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.

Recruiting

Conditions: atopic dermatitis
atopic eczema
10014982

Registration Number: NL-OMON55900

Lead Sponsor: Amsterdam UMC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 316

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;
o Genetic defects associated with photosensitivity or skin cancer;
o Heavily photo-damaged skin;
o History of multiple (>1) skin malignancies;
o Use of systemic immunosuppressants/immunomodulators;
o 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: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome measure: % patients with EASI50 (Eczema Area and Severity<br /><br>Index) at 3 month follow-up.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome measures: Delta EASI, physician-reported clinical signs,<br /><br>patient-reported symptoms, quality of life, long-term control,<br /><br>cost-effectiveness and side effects at 1-3-6-9-12 months. Quantity and potency<br /><br>topical steroid usage, time to starting systemic therapy and patient<br /><br>satisfaction with received treatment. % patients reaching Treatment Target[1]<br /><br>goals and % drop-outs with reasons at 3-6-9-12 months.</p><br>