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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-19

Study Completion Date

2020-02-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Atopic Dermatitis: Early Gene Expression Changes as Predictors of Therapeutic Response to Narrow-band UVB Treatment

NCT03402412

Atopic Dermatitis

UNKNOWN NA

Treatment of Atopic Dermatitis by a Full-Body Blue Light Device

NCT03085303

Dermatitis, Atopic

COMPLETED NA

Medium-Dose UVA1 Versus Narrow-Band UVB in Atopic Dermatitis

NCT00419406

Atopic Dermatitis

COMPLETED NA

Defining the Skin and Blood Biomarkers of Pediatric Atopic Dermatitis

NCT01782703

Atopic Dermatitis Eczema

ACTIVE_NOT_RECRUITING

The UPDATE Trial (Uvb Phototherapy in Dermatology for ATopic Eczema)

NCT05704205

Atopic Dermatitis Eczema Atopic Dermatitis

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Atopic Dermatitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Narrow band UVB treatment (NB-UVB)

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Narrow band UVB treatment (NB-UVB)

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes