Evaluating the effectiveness of NB-UVB phototherapy for atopic eczema
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
This study is testing if a special light treatment called NB-UVB can help adults with atopic eczema who aren't getting enough relief from regular creams.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 316 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 16 sites (Almere, Flevoland and 15 other locations) |
| Trial ID | NCT05704205 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the cost-effectiveness of narrowband UVB (NB-UVB) phototherapy in treating adults with atopic eczema who have not achieved sufficient control with standard topical treatments. Participants will be randomly assigned to receive either NB-UVB phototherapy combined with optimal topical therapy (OTT) for 8-16 weeks or to apply OTT alone for a minimum of 3 months. The study will involve multiple follow-up visits to evaluate the effectiveness of the treatments through questionnaires and clinical assessments. The goal is to provide robust evidence regarding the benefits of NB-UVB phototherapy for this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with moderate atopic eczema that is insufficiently controlled by standard topical care.
Not a fit: Patients with contraindications for NB-UVB or those currently on systemic therapies for atopic eczema may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from atopic eczema.
How similar studies have performed: Previous studies have shown varying degrees of success with phototherapy approaches, but the specific cost-effectiveness of NB-UVB remains under-researched.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Almere, Flevoland and 15 other locations
- Flevoziekenhuis — Almere, Flevoland, Netherlands (Recruiting)
- Medisch Centrum Leeuwarden — Leeuwarden, Friesland, Netherlands (Recruiting)
- Jeroen Bosch Ziekenhuis — Den Bosch, Noord-Brabant, Netherlands (Recruiting)
- Centrum Oosterwal — Alkmaar, Noord-Holland, Netherlands (Recruiting)
- Olvg — Amsterdam, Noord-Holland, Netherlands (Recruiting)
- Amsterdam Universitair Medische Centra — Amsterdam, Noord-Holland, Netherlands (Recruiting)
- Huid Medisch Centrum — Amsterdam, Noord-Holland, Netherlands (Recruiting)
- Bergman Clinics — Haarlem, Noord-Holland, Netherlands (Recruiting)
- Spaarne Gasthuis — Hoofddorp, Noord-Holland, Netherlands (Recruiting)
- Dijklander Ziekenhuis — Purmerend, Noord-Holland, Netherlands (Recruiting)
- Isala Klinieken — Zwolle, Overijssel, Netherlands (Recruiting)
- Meander Medisch Centrum — Amersfoort, Utrecht, Netherlands (Recruiting)
- Reinier de Graaf Gasthuis — Delft, Zuid-Holland, Netherlands (Recruiting)
- Leids Universitair Medisch Centrum — Leiden, Zuid-Holland, Netherlands (Recruiting)
- Alrijne Ziekenhuis — Leiderdorp, Zuid-Holland, Netherlands (Not_yet_recruiting)
- Erasmus Medisch Centrum — Rotterdam, Zuid-Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Louise AA Gerbens, MD PhD — Amsterdam University Medical Centers
- Study coordinator: Prof. Phyllis I Spuls, MD PhD
- Email: ph.i.spuls@amsterdamumc.nl
- Phone: +3120 566 9111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.