Narrowband Ultraviolet B Versus Narrowband Ultraviolet B Plus Ultraviolet A1 for Atopic Eczema

Atopic Eczema Clinical Trial

Official title:

A Randomised Assessor-blinded Study to Compare Narrowband Ultraviolet B With Combined Narrowband Ultraviolet B and Ultraviolet A1 for Atopic Eczema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02915146
• Other study ID #: 2015DS04
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: August 26, 2020

Study information

• Verified date: November 2020
• Source: University of Dundee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Narrowband ultraviolet B phototherapy is the "standard" phototherapy widely used 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 (the molecules that absorb the ultraviolet photons to set in chain the effects we are aiming for) and that 'targetting' several chromophores at once with different wavebands should help. For severe eczema that has not responded adequately to narrowband UVB or ultraviolet A1 alone the combination is sometimes used in the few centres where UVA1 is available.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: August 26, 2020
• Est. primary completion date: August 26, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Atopic Eczema
• Dermatitis, Atopic
• Eczema

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Ninewells Hospital	Dundee

Sponsors (2)

Lead Sponsor	Collaborator
University of Dundee	NHS Tayside

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in EASI (eczema severity score) - proportions reaching 50% reduction	observer-assessed eczema severity	From beginning to end of treatment (25 weeks)
Secondary	POEM (patient orientated eczema measure)	patient-assessed eczema severity	26 weeks after treatment completion