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

February 14, 2024 updated by: Prof. Dr. Phyllis I. Spuls, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

316

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
    • Flevoland
      • Almere, Flevoland, Netherlands, 1315RA
    • Friesland
      • Leeuwarden, Friesland, Netherlands, 8934 AD
        • Recruiting
        • Medisch Centrum Leeuwarden
        • Contact:
    • Noord-Brabant
      • Den Bosch, Noord-Brabant, Netherlands, 5223 GZ
        • Recruiting
        • Jeroen Bosch Ziekenhuis
        • Contact:
    • Noord-Holland
      • Alkmaar, Noord-Holland, Netherlands, 1817 MS
      • Amsterdam, Noord-Holland, Netherlands, 1061 AE
        • Recruiting
        • OLVG
        • Contact:
      • Amsterdam, Noord-Holland, Netherlands, 1105 AZ
      • Amsterdam, Noord-Holland, Netherlands, 1105 BJ
      • Haarlem, Noord-Holland, Netherlands, 2015 BJ
      • Hoofddorp, Noord-Holland, Netherlands, 2134 TM
      • Purmerend, Noord-Holland, Netherlands, 1441 RN
        • Recruiting
        • Dijklander Ziekenhuis
        • Contact:
          • Patrick MJ Kemperman, MD
          • Phone Number: +31299 457 457
    • Overijssel
      • Zwolle, Overijssel, Netherlands
        • Recruiting
        • Isala Klinieken
        • Contact:
          • Wianda C Christoffers
    • Utrecht
      • Amersfoort, Utrecht, Netherlands, 3813 TZ
        • Recruiting
        • Meander Medisch Centrum
        • Contact:
    • Zuid-Holland
      • Delft, Zuid-Holland, Netherlands, 2625 AD
        • Recruiting
        • Reinier de Graaf Gasthuis
        • Contact:
        • Contact:
      • Leiden, Zuid-Holland, Netherlands, 2333 ZA
        • Recruiting
        • Leids Universitair Medisch Centrum
        • Contact:
      • Leiderdorp, Zuid-Holland, Netherlands
        • Not yet recruiting
        • Alrijne ziekenhuis
        • Contact:
          • Ronald Siphanto
      • Rotterdam, Zuid-Holland, Netherlands, 3015 GD
        • Recruiting
        • Erasmus Medisch Centrum
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NB-UVB+OTT
8-16 weeks of NB-UVB phototherapy combined with (a minimum of) 3 months of optimal topical therapy
Device: NB-UVB phototherapy
Narrowband ultraviolet B irradiation 3 times a week
Other Names:
  • Narrowband ultraviolet B phototherapy
Combination product: Optimal topical therapy
A combination of detailed instructions about the disease and treatments by trained nurses, bathing and washing advices, adequate emollients use, avoidance of triggers (including possible and proven contact allergens), fingertip unit explanation for active topical therapy, and personalized topical therapy with different potency topical steroids, calcineurin inhibitors and tar ointments
Other Names:
  • OTT
  • Optimal local therapy
Active Comparator: Optimal topical therapy (OTT)
(a minimum of) 3 months of optimal topical therapy
Combination product: Optimal topical therapy
A combination of detailed instructions about the disease and treatments by trained nurses, bathing and washing advices, adequate emollients use, avoidance of triggers (including possible and proven contact allergens), fingertip unit explanation for active topical therapy, and personalized topical therapy with different potency topical steroids, calcineurin inhibitors and tar ointments
Other Names:
  • OTT
  • Optimal local therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients that reach EASI50
Time Frame: 3 months
Percentage of patients that reach a 50% reduction of the EASI (Eczema Area and Severity Index) at 3 month follow-up
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delta EASI
Time Frame: 3 months
Change in EASI (Eczema Area and Severity Index) at 3 month follow up
3 months
Cost-effectiveness
Time Frame: 1 year
Questionnaire-based calculation of medical consumption- and productivity costs in both arms
1 year
Patient reported outcomes
Time Frame: 1 year
Questionnaire-based review of quality of life, patient satisfaction
1 year
Time to start systemic therapy
Time Frame: 1 year
The time to start of systemic AE treatment in both arms
1 year
Quantity of topical steroid usage
Time Frame: 1 year
The amount of used topical corticosteroids in both groups
1 year
Potency of topical steroid usage
Time Frame: 1 year
The potency (I-IV) of used topical corticosteroids in both groups
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

ZonMw: The Netherlands Organisation for Health Research and Development

Investigators

  • Principal Investigator: Louise AA Gerbens, MD PhD, Amsterdam University Medical Centers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

December 8, 2022

First Submitted That Met QC Criteria

January 19, 2023

First Posted (Actual)

January 30, 2023

Study Record Updates

Last Update Posted (Estimated)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 14, 2024

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL81882.018.22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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