NCT03083730

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 20, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

July 19, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2018

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2020

Completed
Last Updated

February 26, 2020

Status Verified

February 1, 2020

Enrollment Period

1.1 years

First QC Date

March 1, 2017

Last Update Submit

February 25, 2020

Conditions

Atopic Dermatitis

Keywords

Atopic DermatitisEczemaSystemic InflammationUVB Phototherapy

Outcome Measures

Primary Outcomes (1)

  • Systemic Inflammation

    Change from baseline of inflammatory and cardiovascular risk proteins in serum of atopic dermatitis patients during treatment with NB-UVB.

    12 weeks

Secondary Outcomes (7)

  • Microparticles

    12 weeks

  • PBMC activation markers

    12 weeks

  • Disease Scores (SCORAD)

    12 weeks

  • Disease Scores (EASI)

    12 weeks

  • Disease Scores (IGA)

    12 weeks

  • +2 more secondary outcomes

Study Arms (1)

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.

Other: Narrow band UVB treatment (NB-UVB)

Interventions

Narrow band UVB treatment (NB-UVB)OTHER

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

Atopic Dermatitis Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • \. At least 18 years of age

You may not qualify if:

  • 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
  • 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
  • \. 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Rockefeller University

New York, New York, 10065, United States

Location

Related Publications (6)

  • 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.

    PMID: 25579484BACKGROUND

  • Hjuler 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.

    PMID: 26093174BACKGROUND

  • Erbel 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.

    PMID: 20007582BACKGROUND

  • Czarnowicki 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.

    PMID: 25936564BACKGROUND

  • Tamagawa-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.

    PMID: 19217350BACKGROUND

  • Ungar 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.

    PMID: 27825969BACKGROUND

MeSH Terms

Conditions

Dermatitis, AtopicEczema

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Patrick M Brunner, MD

    The Rockefeller University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 1, 2017

First Posted

March 20, 2017

Study Start

July 19, 2017

Primary Completion

August 13, 2018

Study Completion

February 24, 2020

Last Updated

February 26, 2020

Record last verified: 2020-02

Locations

US(1)