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NCT05704205
The UPDATE Trial (Uvb Phototherapy in Dermatology for ATopic Eczema)
Conditions: Atopic Dermatitis Eczema, Atopic Dermatitis
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 316
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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.
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.
Source: ClinicalTrials.gov (NCT05704205). StuddyBuddy aggregates publicly available trial information.