NCT02915146

Brief Summary

Narrowband ultraviolet B phototherapy is the "standard" phototherapy for atopic eczema; ultraviolet A1 is sometimes used but is not a widely available treatment. We do not know the most important chromophores in treating atopic eczema; in which phototherapy is thought to work by improving epidermal barrier function, having beneficial effects on skin microbiome and local immunosuppression. It seems plausible that there are several chromophores and that 'targetting' several at once with different wavebands should help and for severe eczema that has not responded adequately to narrowband UVB or ultraviolet A1 alone the combination is sometimes used. This study is to test if the combination is moderately to greatly more effective than narrowband ultraviolet B monotherapy amongst patients referred for any form of first-line phototherapy for atopic eczema.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 4, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 26, 2016

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 26, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2020

Completed
Last Updated

November 6, 2020

Status Verified

November 1, 2020

Enrollment Period

4.1 years

First QC Date

August 4, 2016

Last Update Submit

November 5, 2020

Conditions

Atopic Eczema

Keywords

eczemaphototherapyuva1uvbadultschildren

Outcome Measures

Primary Outcomes (1)

  • Change in EASI (eczema severity score) - proportions reaching 50% reduction

    observer-assessed eczema severity

    From beginning to end of treatment (25 weeks)

Secondary Outcomes (1)

  • POEM (patient orientated eczema measure)

    26 weeks after treatment completion

Study Arms (2)

NB-UVB monotherapy

ACTIVE COMPARATOR

Narrowband ultraviolet B monotherapy will be used

Radiation: combined ultraviolet phototherapy (NB-UVB + UVA1) vs. NB-UVB monotherapy

NB-UVB + UVA1

ACTIVE COMPARATOR

Narrowband ultraviolet B combined with ultraviolet A1 phototherapy will be used

Radiation: combined ultraviolet phototherapy (NB-UVB + UVA1) vs. NB-UVB monotherapy

Interventions

combined ultraviolet phototherapy (NB-UVB + UVA1) vs. NB-UVB monotherapyRADIATION

NB-UVB combined with UVA1

NB-UVB + UVA1NB-UVB monotherapy

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with atopic eczema as diagnosed by a dermatologist, defined according to the UK Working Party diagnostic criteria, considered for any form of whole body phototherapy
  • Age 12 years and above
  • Able to understand and comply with protocol requirements and treatment visits, instructions and protocol stated restrictions
  • Provision of written informed consent in accordance with the Scottish Children's Network consent guidance and standard operating procedure (SOP) for subjects aged 12-15 years
  • Provision of written informed consent (subjects age 16 years and over)

You may not qualify if:

  • Unable to provide written informed consent in accordance with the Scottish Children's Network consent guidance and SOP
  • Unable to provide written informed consent (subjects age 16 years and over)
  • Currently being treated, or treated within the past 2 weeks, with systemic immunosuppressive therapy
  • Current use of drugs known to cause photosensitivity
  • Phototherapy, photochemotherapy, or sunbed use in the preceding 3 months
  • Known abnormal photosensitivity
  • Previous history of skin cancer
  • Participation in another research study within the past three months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ninewells Hospital

Dundee, DD1 9SY, United Kingdom

Location

MeSH Terms

Conditions

Dermatitis, AtopicEczema

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Robert S Dawe

    NHS Tayside and University of Dundee

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2016

First Posted

September 26, 2016

Study Start

August 1, 2016

Primary Completion

August 26, 2020

Study Completion

August 26, 2020

Last Updated

November 6, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will share

Locations

GB(1)