Moderate to Severe Atopic EczemaNCT01569906
Narrowband UVB for Children With Moderate to Severe Atopic Eczema
An observational study of Moderate to Severe Atopic Eczema, run by Royal Victoria Infirmary at 1 site in United Kingdom.
Trial summary
To assess prospectively, the response of moderate to severe atopic eczema to a standard course of narrowband ultraviolet B phototherapy by using validated objective and subjective scoring systems. Read more about this study
- Who is it for?
- Ages 3 to 16 years
- Conditions the study is for
- Moderate to Severe Atopic Eczema
- What is being tested?
- Narrowband Ultraviolet B phototherapy
- Type of treatment
- Surgery or procedure
- How many people
- 58 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2009to Aug 2010
- Phase
- Observational
- 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 3 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Children aged 3-16 years
Who may be able to join
- Children aged 3-16 years with moderate to severe atopic eczema (as defined by the modified Hannifin and Rajka criteria) in whom there is a clinical indication for phototherapy (as deemed by their specialist Dermatology consultant).
Who cannot join
- Children under the age of 3 years or any child who lacks the maturity needed to stand in the phototherapy cabinet unsupervised.
- Mild disease (defined as a Six Area Six Sign Atopic Dermatitis (SASSAD) score <10)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4LP
About this study
Official title: Narrowband Ultraviolet B Phototherapy in Children With Moderate to Severe Atopic Eczema- an Observational Prospective Controlled Study
To assess prospectively, the response of moderate to severe atopic eczema to a standard course of narrowband ultraviolet B phototherapy by using validated objective and subjective scoring systems.
Read the detailed description
Children with moderate to severe atopic eczema prescribed a course of narrowband UVB phototherapy were scored (using validated scoring systems) objectively and subjectively before, during and after the course of treatment, as well as 3 and 6 months post treatment (to determine length of remission). Their scores were compared to a control group. The control group comprised children with moderate to severe atopic eczema who were offered UVB but were unable to undertake the treatment.
- Conditions
- Moderate to Severe Atopic Eczema
- Being tested
- Narrowband Ultraviolet B phototherapy
- Keywords
- Atopic Dermatitis
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrowband Ultraviolet B phototherapyRadiation
Twice weekly exposures for a total of 24 exposures using a standard phototherapy protocol.
| Study group | Role | What they receive |
|---|---|---|
| UVB | Children with moderate to severe atopic eczema who undertook a standard course of narrowband Ultraviolet B (NBUVB) phototherapy Receives: Radiation: Narrowband Ultraviolet B phototherapy | |
| Controls | Children with moderate to severe atopic eczema who were offered UVB but were unable to undertake treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score at the end of treatment compared to the control group
Measurement of Six Area Six Sign Atopic Dermatitis (SASSAD) score and percentage surface area affected of those treated with narrowband UVB as compared to a control group
Measured: 12 weeks
Secondary outcomes (6)
Subjective scores at the end of treatment as compared to controls
Subjective scoring using Patient Outcome Eczema Measure (POEM), Children's Dermatology Life Quality Index (CDLQI), Dermatitis Family Impact Questionnaire (DFI), Visual analogue scale (VAS) for itch and sleep loss
Measured: 12 weeks
objective scores at 3 months post treatment compared to controls
Objective Six Area Six Sign Atopic Dermatitis (SASSAD) score and percentage surface area affected in the treated group at 3 months post treatment as compared to controls.
Measured: 3 months
Association of filaggrin status with outcome
To determine if response to phototherapy is determined by the presence of a homozygous or compound heterozygous filaggrin mutation.
Measured: 12 weeks
Subjective scores at 3 months post treatment compared to controls
Subjective scores (Patient Outcome Eczema Measure (POEM),Children's Dermatology Life Quality Index (CDLQI), Dermatitis Family Impact Questionnaire (DFI), Visual Analogue Scale (VAS) for itch and sleep loss) in the treated group at 3 months post treatment as compared to controls.
Measured: 3 months
Subjective scores at 6 months post treatment compared to controls
Subjective scores (Patient Outcome Eczema Measure (POEM),Children's Dermatology Life Quality Index (CDLQI), Dermatitis Family Impact Questionnaire (DFI), Visual Analogue Scale (VAS) for itch and sleep loss) in the treated group at 6 months post treatment as compared to controls.
Measured: 6 months
Objective scores at 6 months post treatment compared to controls
Objective Six Area Six Sign Atopic Dermatitis (SASSAD) score and percentage surface area affected in the treated group at 6 months post treatment as compared to controls.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2012 (estimated)
- Study startApr 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Victoria Infirmary
- Sponsor type
- University, hospital or other
- Collaborators
- British Skin Foundation
- Responsible party
- Principal investigator, Dr AEM Taylor, Royal Victoria Infirmary
- Investigators
- Aileen EM Taylor, MBChB, Principal investigator, Royal Victoria Infirmary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01569906
- Sponsor's protocol ID
- 4795
- Other IDs
- 7282
- Status last verified
- Apr 2012
- First submitted
- 30 Mar 2012
- Last updated
- 5 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Narrowband Ultraviolet B Phototherapy in Children With Moderate to Severe Atopic Eczema- an Observational Prospective Controlled Study
- ClinicalTrials.gov ID
- NCT01569906
- Acronym / sponsor ID
- 4795
- Conditions
- Moderate to Severe Atopic Eczema
- Keywords
- Atopic Dermatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Royal Victoria InfirmaryUniversity, hospital or other
- Collaborators
- British Skin Foundation
- Study start
- Apr 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 3 Apr 2012 (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.
To assess prospectively, the response of moderate to severe atopic eczema to a standard course of narrowband ultraviolet B phototherapy by using validated objective and subjective scoring systems.
Detailed description
Children with moderate to severe atopic eczema prescribed a course of narrowband UVB phototherapy were scored (using validated scoring systems) objectively and subjectively before, during and after the course of treatment, as well as 3 and 6 months post treatment (to determine length of remission). Their scores were compared to a control group. The control group comprised children with moderate to severe atopic eczema who were offered UVB but were unable to undertake the treatment.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UVB | – | Radiation: Narrowband Ultraviolet B phototherapyChildren with moderate to severe atopic eczema who undertook a standard course of narrowband Ultraviolet B (NBUVB) phototherapy |
| Controls | – | –Children with moderate to severe atopic eczema who were offered UVB but were unable to undertake treatment |
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged 3-16 years
Key inclusion criteria (1 listed)
- Children aged 3-16 years with moderate to severe atopic eczema (as defined by the modified Hannifin and Rajka criteria) in whom there is a clinical indication for phototherapy (as deemed by their specialist Dermatology consultant).
Key exclusion criteria (2 listed)
- Children under the age of 3 years or any child who lacks the maturity needed to stand in the phototherapy cabinet unsupervised.
- Mild disease (defined as a Six Area Six Sign Atopic Dermatitis (SASSAD) score <10)
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 |
|---|---|---|
| Narrowband Ultraviolet B phototherapyTwice weekly exposures for a total of 24 exposures using a standard phototherapy protocol. | Radiation | UVB |
Primary outcome
Score at the end of treatment compared to the control group
Time frame: 12 weeks
Measurement of Six Area Six Sign Atopic Dermatitis (SASSAD) score and percentage surface area affected of those treated with narrowband UVB as compared to a control group
6 secondary outcomes
Subjective scores at the end of treatment as compared to controls
Time frame: 12 weeks
objective scores at 3 months post treatment compared to controls
Time frame: 3 months
Association of filaggrin status with outcome
Time frame: 12 weeks
Subjective scores at 3 months post treatment compared to controls
Time frame: 3 months
Subjective scores at 6 months post treatment compared to controls
Time frame: 6 months
Objective scores at 6 months post treatment compared to controls
Time frame: 6 months
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 5 Apr 2012.
Related trials for Moderate to Severe Atopic Eczema
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
RecruitingPhase 3
Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis
Atopic Dermatitis, Atopic Dermatitis (AD)
RecruitingPhase 3
A Long-term Study of the Medicine Called Abrocitinib in Children Aged 2 Years and Older With Moderate to Severe Eczema
Atopic Dermatitis
RecruitingPhase 2
A Study to Learn About Study Medicine Called PF-08049820 in People With Eczema
Atopic Dermatitis, Eczema, Atopic
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.
Aileen EM Taylor, MBChB principal investigator
Royal Victoria Infirmary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Moderate to Severe Atopic Eczema, run by Royal Victoria Infirmary 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 1 inclusion and 2 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 5 Apr 2012. 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?
Score at the end of treatment compared to the control group (time frame: 12 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 5 Apr 2012.