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
|Condition or disease||Intervention/treatment||Phase|
|Atopic Dermatitis||Other: Narrow band UVB treatment (NB-UVB)||Not Applicable|
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 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|
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)
- 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.
- Microparticles [ Time Frame: 12 weeks ]Change from baseline of microparticles in the peripheral blood of Atopic Dermatitis patients treated with NB-UVB
- 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
- Disease Scores (SCORAD) [ Time Frame: 12 weeks ]Change from baseline in clinical skin disease scores (SCORAD) in Atopic Dermatitis patients treated with NBUVB
- Disease Scores (EASI) [ Time Frame: 12 weeks ]Change from baseline in clinical skin disease scores (EASI) in Atopic Dermatitis patients treated with NBUVB
- Disease Scores (IGA) [ Time Frame: 12 weeks ]Change from baseline in clinical skin disease scores (IGA) in Atopic Dermatitis patients treated with NBUVB
- Comparison to healthy controls [ Time Frame: 12 weeks ]Number of markers significantly increased/decreased compared to healthy control samples, and their change during treatment
- Correlation with skin markers [ Time Frame: 12 weeks ]Correlation of inflammatory markers between serum and skin before and after NB-UVB treatment
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
|United States, New York|
|The Rockefeller University|
|New York, New York, United States, 10065|
|Principal Investigator:||Patrick M Brunner, MD||The Rockefeller University|