Atopic EczemaNCT02915146
Narrowband Ultraviolet B Versus Narrowband Ultraviolet B Plus Ultraviolet A1 for Atopic Eczema
A study testing combined ultraviolet phototherapy (NB-UVB + UVA1) vs. NB-UVB monotherapy in people with Atopic Eczema, run by University of Dundee at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atopic Eczema
- What is being tested?
- combined ultraviolet phototherapy (NB-UVB + UVA1) vs. NB-UVB monotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2016to 26 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Assessor-blinded Study to Compare Narrowband Ultraviolet B With Combined Narrowband Ultraviolet B and Ultraviolet A1 for Atopic Eczema
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.
Read the detailed 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.
- Conditions
- Atopic Eczema
- Being tested
- combined ultraviolet phototherapy (NB-UVB + UVA1) vs. NB-UVB monotherapy
- Keywords
- eczema, phototherapy, uva1, uvb, adults, children
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combined ultraviolet phototherapy (NB-UVB + UVA1) vs. NB-UVB monotherapyRadiation
NB-UVB combined with UVA1
| Study group | Role | What they receive |
|---|---|---|
| NB-UVB monotherapy | Active comparator | Narrowband ultraviolet B monotherapy will be used Receives: 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 Receives: Radiation: combined ultraviolet phototherapy (NB-UVB + UVA1) vs. NB-UVB monotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in EASI (eczema severity score) - proportions reaching 50% reduction
observer-assessed eczema severity
Measured: From beginning to end of treatment (25 weeks)
Secondary outcomes (1)
POEM (patient orientated eczema measure)
patient-assessed eczema severity
Measured: 26 weeks after treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study startAug 2016
- Primary completion26 Aug 2020
- Study completion26 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic EczemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dundee
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Tayside
- Responsible party
- Sponsor
- Investigators
- Robert S Dawe, Principal investigator, NHS Tayside and University of Dundee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02915146
- Sponsor's protocol ID
- 2015DS04
- Status last verified
- Nov 2020
- First submitted
- 4 Aug 2016
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Assessor-blinded Study to Compare Narrowband Ultraviolet B With Combined Narrowband Ultraviolet B and Ultraviolet A1 for Atopic Eczema
- ClinicalTrials.gov ID
- NCT02915146
- Acronym / sponsor ID
- 2015DS04
- Conditions
- Atopic Eczema
- Keywords
- eczema, phototherapy, uva1, uvb, adults, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of DundeeUniversity, hospital or other
- Collaborators
- NHS Tayside
- Study start
- Aug 2016 (actual)
- Primary completion
- 26 Aug 2020 (actual)
- Study completion
- 26 Aug 2020 (actual)
- First posted
- 26 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NB-UVB monotherapy | Active comparator | Radiation: combined ultraviolet phototherapy (NB-UVB + UVA1) vs. NB-UVB monotherapyNarrowband ultraviolet B monotherapy will be used |
| NB-UVB + UVA1 | Active comparator | Radiation: combined ultraviolet phototherapy (NB-UVB + UVA1) vs. NB-UVB monotherapyNarrowband ultraviolet B combined with ultraviolet A1 phototherapy will be used |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| combined ultraviolet phototherapy (NB-UVB + UVA1) vs. NB-UVB monotherapyNB-UVB combined with UVA1 | Radiation | NB-UVB + UVA1, NB-UVB monotherapy |
Primary outcome
Change in EASI (eczema severity score) - proportions reaching 50% reduction
Time frame: From beginning to end of treatment (25 weeks)
observer-assessed eczema severity
1 secondary outcome
POEM (patient orientated eczema measure)
Time frame: 26 weeks after treatment completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
- Individual participant dataSharing planned: Yes
Related trials for Atopic Eczema
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert S Dawe principal investigator
NHS Tayside and University of Dundee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing combined ultraviolet phototherapy (NB-UVB + UVA1) vs. NB-UVB monotherapy in people with Atopic Eczema, run by University of Dundee at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in EASI (eczema severity score) - proportions reaching 50% reduction (time frame: From beginning to end of treatment (25 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2020.