Evaluating the effectiveness of NB-UVB phototherapy for atopic eczema

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.