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Impact of Narrowband UVB Phototherapy on Systemic Inflammation in Patients With Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT03083730
Recruitment Status : Active, not recruiting
First Posted : March 20, 2017
Last Update Posted : December 25, 2018
Sponsor:
Information provided by (Responsible Party):
James G. Krueger, MD, PhD, Rockefeller University

Brief 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 treatment can alleviate systemic inflammation, and potentially influence cardiovascular risk factors.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Other: Narrow band UVB treatment (NB-UVB) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Impact of Narrowband UVB Phototherapy on Systemic Inflammation in Patients With Atopic Dermatitis
Actual Study Start Date : July 19, 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: Atopic Dermatitis Cohort

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.

Other: Narrow band UVB treatment (NB-UVB)
NB-UVB light treatment NB-UVB light treatment for 3x/week for 12 weeks (36 visits)




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Microparticles [ Time Frame: 12 weeks ]
    Change from baseline of microparticles in the peripheral blood of Atopic Dermatitis patients treated with NB-UVB

  2. PBMC activation markers [ Time Frame: 12 weeks ]
    Change from baseline in PBMC activation markers in the peripheral blood of Atopic Dermatitis patients treated with NBUVB

  3. Disease Scores (SCORAD) [ Time Frame: 12 weeks ]
    Change from baseline in clinical skin disease scores (SCORAD) in Atopic Dermatitis patients treated with NBUVB

  4. Disease Scores (EASI) [ Time Frame: 12 weeks ]
    Change from baseline in clinical skin disease scores (EASI) in Atopic Dermatitis patients treated with NBUVB

  5. Disease Scores (IGA) [ Time Frame: 12 weeks ]
    Change from baseline in clinical skin disease scores (IGA) in Atopic Dermatitis patients treated with NBUVB

  6. Comparison to healthy controls [ Time Frame: 12 weeks ]
    Number of markers significantly increased/decreased compared to healthy control samples, and their change during treatment

  7. Correlation with skin markers [ Time Frame: 12 weeks ]
    Correlation of inflammatory markers between serum and skin before and after NB-UVB treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

ATOPIC DERMATITIS COHORT

  1. At least 18 years of age
  2. >10% body surface affected
  3. History of atopic dermatitis for at least 3 years (as per patient history)

HEALTHY CONTROL COHORT

1. At least 18 years of age

Exclusion Criteria:

ATOPIC DERMATITIS COHORT

  1. 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.
  2. Use of topical glucocorticosteroids or other immunosuppressive topical therapy within 1 week of treatment initiation. Emollients are allowed.
  3. Untreated skin malignancy
  4. Use of systemic anti-inflammatory medication in the last 4 weeks for more than 3 days
  5. Known photosensitivity: Hypersensitivity to sunlight or UVB light of any type or photosensitizing medication
  6. History of Lupus, Polymorphic light eruption (PMLE), or any disease known to be worsened by UV light exposure
  7. History of melanoma
  8. 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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03083730


Locations
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United States, New York
The Rockefeller University
New York, New York, United States, 10065
Sponsors and Collaborators
Rockefeller University
Investigators
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Principal Investigator: Patrick M Brunner, MD The Rockefeller University

Publications:

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Responsible Party: James G. Krueger, MD, PhD, Professor, Rockefeller University
ClinicalTrials.gov Identifier: NCT03083730     History of Changes
Other Study ID Numbers: PBR-0933
First Posted: March 20, 2017    Key Record Dates
Last Update Posted: December 25, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by James G. Krueger, MD, PhD, Rockefeller University:
Atopic Dermatitis
Eczema
Systemic Inflammation
UVB Phototherapy

Additional relevant MeSH terms:
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Eczema
Inflammation
Dermatitis
Dermatitis, Atopic
Pathologic Processes
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases