Atopic DermatitisNCT03083730
Impact of Narrowband UVB Phototherapy on Systemic Inflammation in Patients With Atopic Dermatitis
A study testing Narrow band UVB treatment (NB-UVB) in people with Atopic Dermatitis, run by Rockefeller University at 1 site in United States.
Trial summary
Atopic dermatitis (eczema) is a chronic inflammatory disease that causes significant morbidity and is now known to be associated with cardiovascular disease. Research such as this will add to the understanding of the skin as a contributor to systemic inflammation, and it is important to clarify whether skin-only… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Narrow band UVB treatment (NB-UVB)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2017to 24 Feb 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ATOPIC DERMATITIS COHORT
- At least 18 years of age
- >10% body surface affected
- History of atopic dermatitis for at least 3 years (as per patient history)
- HEALTHY CONTROL COHORT
- 1. At least 18 years of age
Who cannot join
- ATOPIC DERMATITIS COHORT
- Unstable or persistent asthma (mild, moderate, or severe), i.e. all forms of allergic asthma that are other than intermittent asthma. Intermittent asthma is allowed: Difficulty breathing, wheezing, chest tightness, and coughing occur on fewer than 2 days a week, do not interfere with normal activities, and nighttime symptoms occur on fewer than 2 days a month.
- Use of topical glucocorticosteroids or other immunosuppressive topical therapy within 1 week of treatment initiation. Emollients are allowed.
- Untreated skin malignancy
- Use of systemic anti-inflammatory medication in the last 4 weeks for more than 3 days
- Known photosensitivity: Hypersensitivity to sunlight or UVB light of any type or photosensitizing medication
Show all 11Show fewer
- History of Lupus, Polymorphic light eruption (PMLE), or any disease known to be worsened by UV light exposure
- History of melanoma
- History, physical, social or lab findings suggestive of any medical or psychological condition that would, in the opinion of the PI make the candidate ineligible for the study
- HEALTHY CONTROL COHORT
- 1. self-reported chronic inflammatory diseases (IBD, rheumatoid arthritis, collagenoses, chronic inflammatory skin disease, Atopic Dermatitis, autoimmune or autoinflammatory disease, active tuberculosis, chronic infectious disease such as HIV and hepatitis)
Trial locations and contacts
1 site in 1 country.
United States1 site
The Rockefeller University
New York, New York, 10065
About this study
Atopic dermatitis (eczema) is a chronic inflammatory disease that causes significant morbidity and is now known to be associated with cardiovascular disease. Research such as this will add to the understanding of the skin as a contributor to systemic inflammation, and it is important to clarify whether skin-only treatment can alleviate systemic inflammation, and potentially influence cardiovascular risk factors.
Read the detailed description
Globally, the leading cause of death is cardiovascular disease, which is often linked to chronic inflammation.
Recently, it has been shown that atopic dermatitis (AD), the most common chronic inflammatory skin disease, shows increases in inflammatory and cardiovascular risk markers in patient blood (proteins, microparticles, circulating inflammatory cells). Consistently, it has been demonstrated that atopic dermatitis is associated with increased cardiovascular disease. Whether these increases in inflammatory and/or cardiovascular risk markers in the peripheral blood are due to skin inflammation, or due to other body sources (e.g. lung, lymphatic system) is unknown.
To investigate whether some (or all) risk proteins present in patient blood are produced in inflamed skin, the investigators want to treat patients suffering from moderate-to-severe AD with ultra-violet light B (UVB) therapy, as this therapy is thought to be an exclusive skin treatment, without direct systemic effects. This notion is corroborated by the fact that only skin regions directly treated with UVB light, and not covered skin regions, respond to phototherapy.
Ultra-violet light B (UVB) therapy has been used by dermatologists to treat AD for decades, and in the 1990ies, narrow band-UVB (NB-UVB) wavelengths (311-312nm) were found to have the best treatment effects. This is a safe and effective therapy for the majority of patients, with the main drawback being that it is inconvenient, as patients need to attend the clinic three times a week for at least 8 weeks. The mechanism of action appears to include killing of skin immune cells, and it also appears to down regulate inflammatory molecules such as IFNg, IL-12 and IL-23. However, a systematic study of the impact of NBUVB on blood biomarkers has never been performed. In this study, participants will be treated with an appropriate dose of NB-UVB three times a week for up to 12 weeks or a total of 36 treatments, and blood will be drawn to assess inflammatory and cardiovascular risk markers (proteins, microparticles, circulating blood cells). Results will be compared to levels in blood from healthy control participants. This study could lead to a new understanding on the role of the skin as a source of systemic inflammation, which would help to guide future treatment approaches for this debilitating, chronic skin disease.
- Conditions
- Atopic Dermatitis
- Being tested
- Narrow band UVB treatment (NB-UVB)
- Keywords
- Atopic Dermatitis, Eczema, Systemic Inflammation, UVB Phototherapy
- 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.
Narrow band UVB treatment (NB-UVB)Other
NB-UVB light treatment NB-UVB light treatment for 3x/week for 12 weeks (36 visits)
| Study group | Role | What they receive |
|---|---|---|
| Atopic Dermatitis Cohort | Experimental | Narrow band UVB treatment (NB-UVB) NB-UVB light treatment 3x/week for 12 weeks (36 visits)
Healthy Control Cohort will be obtained to take baseline blood work as a reference value for baseline expression of blood markers. Receives: Other: Narrow band UVB treatment (NB-UVB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic Inflammation
Change from baseline of inflammatory and cardiovascular risk proteins in serum of atopic dermatitis patients during treatment with NB-UVB.
Measured: 12 weeks
Secondary outcomes (7)
Microparticles
Change from baseline of microparticles in the peripheral blood of Atopic Dermatitis patients treated with NB-UVB
Measured: 12 weeks
PBMC activation markers
Change from baseline in PBMC activation markers in the peripheral blood of Atopic Dermatitis patients treated with NBUVB
Measured: 12 weeks
Disease Scores (SCORAD)
Change from baseline in clinical skin disease scores (SCORAD) in Atopic Dermatitis patients treated with NBUVB
Measured: 12 weeks
Disease Scores (EASI)
Change from baseline in clinical skin disease scores (EASI) in Atopic Dermatitis patients treated with NBUVB
Measured: 12 weeks
Disease Scores (IGA)
Change from baseline in clinical skin disease scores (IGA) in Atopic Dermatitis patients treated with NBUVB
Measured: 12 weeks
Comparison to healthy controls
Number of markers significantly increased/decreased compared to healthy control samples, and their change during treatment
Measured: 12 weeks
Correlation with skin markers
Correlation of inflammatory markers between serum and skin before and after NB-UVB treatment
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2017
- Study start19 Jul 2017
- Primary completion13 Aug 2018
- Study completion24 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rockefeller University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James G. Krueger, MD, PhD, Rockefeller University
- Investigators
- Patrick M Brunner, MD, Principal investigator, The Rockefeller University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03083730
- Sponsor's protocol ID
- PBR-0933
- Status last verified
- Feb 2020
- First submitted
- 1 Mar 2017
- Last updated
- 26 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Silverberg JI, Greenland P. Eczema and cardiovascular risk factors in 2 US adult population studies. J Allergy Clin Immunol. 2015 Mar;135(3):721-8.e6. doi: 10.1016/j.jaci.2014.11.023. Epub 2015 Jan 8.
PubMed 25579484Hjuler KF, Bottcher M, Vestergaard C, Deleuran M, Raaby L, Botker HE, Iversen L, Kragballe K. Increased Prevalence of Coronary Artery Disease in Severe Psoriasis and Severe Atopic Dermatitis. Am J Med. 2015 Dec;128(12):1325-34.e2. doi: 10.1016/j.amjmed.2015.05.041. Epub 2015 Jun 18.
PubMed 26093174Erbel C, Chen L, Bea F, Wangler S, Celik S, Lasitschka F, Wang Y, Bockler D, Katus HA, Dengler TJ. Inhibition of IL-17A attenuates atherosclerotic lesion development in apoE-deficient mice. J Immunol. 2009 Dec 15;183(12):8167-75. doi: 10.4049/jimmunol.0901126.
PubMed 20007582Czarnowicki T, Malajian D, Shemer A, Fuentes-Duculan J, Gonzalez J, Suarez-Farinas M, Krueger JG, Guttman-Yassky E. Skin-homing and systemic T-cell subsets show higher activation in atopic dermatitis versus psoriasis. J Allergy Clin Immunol. 2015 Jul;136(1):208-11. doi: 10.1016/j.jaci.2015.03.032. Epub 2015 May 1. No abstract available.
PubMed 25936564Tamagawa-Mineoka R, Katoh N, Ueda E, Masuda K, Kishimoto S. Platelet-derived microparticles and soluble P-selectin as platelet activation markers in patients with atopic dermatitis. Clin Immunol. 2009 Jun;131(3):495-500. doi: 10.1016/j.clim.2009.01.006. Epub 2009 Feb 13.
PubMed 19217350Ungar B, Garcet S, Gonzalez J, Dhingra N, Correa da Rosa J, Shemer A, Krueger JG, Suarez-Farinas M, Guttman-Yassky E. An Integrated Model of Atopic Dermatitis Biomarkers Highlights the Systemic Nature of the Disease. J Invest Dermatol. 2017 Mar;137(3):603-613. doi: 10.1016/j.jid.2016.09.037. Epub 2016 Nov 4.
PubMed 27825969
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Narrowband UVB Phototherapy on Systemic Inflammation in Patients With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03083730
- Acronym / sponsor ID
- PBR-0933
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic Dermatitis, Eczema, Systemic Inflammation, UVB Phototherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Rockefeller UniversityUniversity, hospital or other
- Study start
- 19 Jul 2017 (actual)
- Primary completion
- 13 Aug 2018 (actual)
- Study completion
- 24 Feb 2020 (actual)
- First posted
- 20 Mar 2017 (actual)
- 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.
Atopic dermatitis (eczema) is a chronic inflammatory disease that causes significant morbidity and is now known to be associated with cardiovascular disease. Research such as this will add to the understanding of the skin as a contributor to systemic inflammation, and it is important to clarify whether skin-only treatment can alleviate systemic inflammation, and potentially influence cardiovascular risk factors.
Detailed description
Globally, the leading cause of death is cardiovascular disease, which is often linked to chronic inflammation.
Recently, it has been shown that atopic dermatitis (AD), the most common chronic inflammatory skin disease, shows increases in inflammatory and cardiovascular risk markers in patient blood (proteins, microparticles, circulating inflammatory cells). Consistently, it has been demonstrated that atopic dermatitis is associated with increased cardiovascular disease. Whether these increases in inflammatory and/or cardiovascular risk markers in the peripheral blood are due to skin inflammation, or due to other body sources (e.g. lung, lymphatic system) is unknown.
To investigate whether some (or all) risk proteins present in patient blood are produced in inflamed skin, the investigators want to treat patients suffering from moderate-to-severe AD with ultra-violet light B (UVB) therapy, as this therapy is thought to be an exclusive skin treatment, without direct systemic effects. This notion is corroborated by the fact that only skin regions directly treated with UVB light, and not covered skin regions, respond to phototherapy.
Ultra-violet light B (UVB) therapy has been used by dermatologists to treat AD for decades, and in the 1990ies, narrow band-UVB (NB-UVB) wavelengths (311-312nm) were found to have the best treatment effects. This is a safe and effective therapy for the majority of patients, with the main drawback being that it is inconvenient, as patients need to attend the clinic three times a week for at least 8 weeks. The mechanism of action appears to include killing of skin immune cells, and it also appears to down regulate inflammatory molecules such as IFNg, IL-12 and IL-23. However, a systematic study of the impact of NBUVB on blood biomarkers has never been performed. In this study, participants will be treated with an appropriate dose of NB-UVB three times a week for up to 12 weeks or a total of 36 treatments, and blood will be drawn to assess inflammatory and cardiovascular risk markers (proteins, microparticles, circulating blood cells). Results will be compared to levels in blood from healthy control participants. This study could lead to a new understanding on the role of the skin as a source of systemic inflammation, which would help to guide future treatment approaches for this debilitating, chronic skin disease.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atopic Dermatitis Cohort | Experimental | Other: Narrow band UVB treatment (NB-UVB)Narrow band UVB treatment (NB-UVB) NB-UVB light treatment 3x/week for 12 weeks (36 visits) Healthy Control Cohort will be obtained to take baseline blood work as a reference value for baseline expression of blood markers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ATOPIC DERMATITIS COHORT
- At least 18 years of age
- >10% body surface affected
- History of atopic dermatitis for at least 3 years (as per patient history)
- HEALTHY CONTROL COHORT
Key exclusion criteria (11 listed)
- ATOPIC DERMATITIS COHORT
- Unstable or persistent asthma (mild, moderate, or severe), i.e. all forms of allergic asthma that are other than intermittent asthma. Intermittent asthma is allowed: Difficulty breathing, wheezing, chest tightness, and coughing occur on fewer than 2 days a week, do not interfere with normal activities, and nighttime symptoms occur on fewer than 2 days a month.
- Use of topical glucocorticosteroids or other immunosuppressive topical therapy within 1 week of treatment initiation. Emollients are allowed.
- Untreated skin malignancy
- Use of systemic anti-inflammatory medication in the last 4 weeks for more than 3 days
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 |
|---|---|---|
| Narrow band UVB treatment (NB-UVB)NB-UVB light treatment NB-UVB light treatment for 3x/week for 12 weeks (36 visits) | Other | Atopic Dermatitis Cohort |
Primary outcome
Systemic Inflammation
Time frame: 12 weeks
Change from baseline of inflammatory and cardiovascular risk proteins in serum of atopic dermatitis patients during treatment with NB-UVB.
7 secondary outcomes
Microparticles
Time frame: 12 weeks
PBMC activation markers
Time frame: 12 weeks
Disease Scores (SCORAD)
Time frame: 12 weeks
Disease Scores (EASI)
Time frame: 12 weeks
Disease Scores (IGA)
Time frame: 12 weeks
Comparison to healthy controls
Time frame: 12 weeks
Correlation with skin markers
Time frame: 12 weeks
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 26 Feb 2020.
- Background: PubMed 25579484Silverberg JI, Greenland P. Eczema and cardiovascular risk factors in 2 US adult population studies. J Allergy Clin Immunol. 2015 Mar;135(3):721-8.e6. doi: 10.1016/j.jaci.2014.11.023. Epub 2015 Jan 8.
- Background: PubMed 26093174Hjuler KF, Bottcher M, Vestergaard C, Deleuran M, Raaby L, Botker HE, Iversen L, Kragballe K. Increased Prevalence of Coronary Artery Disease in Severe Psoriasis and Severe Atopic Dermatitis. Am J Med. 2015 Dec;128(12):1325-34.e2. doi: 10.1016/j.amjmed.2015.05.041. Epub 2015 Jun 18.
- Background: PubMed 20007582Erbel C, Chen L, Bea F, Wangler S, Celik S, Lasitschka F, Wang Y, Bockler D, Katus HA, Dengler TJ. Inhibition of IL-17A attenuates atherosclerotic lesion development in apoE-deficient mice. J Immunol. 2009 Dec 15;183(12):8167-75. doi: 10.4049/jimmunol.0901126.
- Background: PubMed 25936564Czarnowicki T, Malajian D, Shemer A, Fuentes-Duculan J, Gonzalez J, Suarez-Farinas M, Krueger JG, Guttman-Yassky E. Skin-homing and systemic T-cell subsets show higher activation in atopic dermatitis versus psoriasis. J Allergy Clin Immunol. 2015 Jul;136(1):208-11. doi: 10.1016/j.jaci.2015.03.032. Epub 2015 May 1. No abstract available.
- Background: PubMed 19217350Tamagawa-Mineoka R, Katoh N, Ueda E, Masuda K, Kishimoto S. Platelet-derived microparticles and soluble P-selectin as platelet activation markers in patients with atopic dermatitis. Clin Immunol. 2009 Jun;131(3):495-500. doi: 10.1016/j.clim.2009.01.006. Epub 2009 Feb 13.
- Background: PubMed 27825969Ungar B, Garcet S, Gonzalez J, Dhingra N, Correa da Rosa J, Shemer A, Krueger JG, Suarez-Farinas M, Guttman-Yassky E. An Integrated Model of Atopic Dermatitis Biomarkers Highlights the Systemic Nature of the Disease. J Invest Dermatol. 2017 Mar;137(3):603-613. doi: 10.1016/j.jid.2016.09.037. Epub 2016 Nov 4.
- Individual participant dataSharing planned: Undecided
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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.
Patrick M Brunner, MD principal investigator
The Rockefeller University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Narrow band UVB treatment (NB-UVB) in people with Atopic Dermatitis, run by Rockefeller University at 1 site in United States.
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 6 inclusion and 11 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 26 Feb 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 States. 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?
Systemic Inflammation (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03083730, which also lists 6 linked publications.
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 26 Feb 2020.