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NCT03402412 Clinical Trial

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

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03402412
Other study ID # 2017/466
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 19, 2017
Est. completion date December 1, 2021

Study information
Verified date March 2021
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Phototherapy with narrow band (nb) ultraviolet B (UVB) is a safe and effective but time consuming treatment option for patients with widespread eczema. Despite efficacy we know little about how it works, and even less why some patients fail to respond. Tintle et al showed that nb-UVB induced strong suppression of the Th2 and Th22 axes in patients with atopic dermatitis (AD), and also normalized the epidermal barrier function. We want to map the very early changes in gene expression after UVB-treatment in order to shed light on disease mechanisms, which eventually could lead to better treatment options.

Description:

Patients will be scored with Patient-Oriented Eczema Measure (POEM), Eczema Area and Severity Index (EASI), SCORAD (SCORing Atopic Dermatitis) and Dermatology Life Quality Index (DLQI) to assess disease severity. The investigators will measure trans epidermal water loss (TEWL), take bacterial swabs for analysis of the microbiome and culture for Staphylococcus aureus and test for mutations in the filaggrin-gene by sputum samples. Blood serum samples will be taken to measure serum (s) -Immunoglobulin E, s-vitamin D status, full blood count including white cell differential and different cytokines. Any history of allergic asthma, allergic rhinitis or food allergy will be noted as well as any recent history of sun exposure, use of tanning beds or UVB-therapy. The suberythemal dose of UVB for each patient will be established. In each patient two contralateral areas (e.g. both underarms) with eczema will be chosen, which are as similar as possible regarding distribution and severity. One area will be biopsied with a 4mm punch followed by locally treatment with nb-UVB (311nm) three times. In this way the untreated side will serve as an internal control. Both sides will be biopsied after these initial three rounds of treatment. The patients will then undergo 24 standard full-body nb-UV-treatment sessions followed by a new biopsy of the same area. Skin from non-lesional sun-protected skin from nates will also be samples prior to and after UVB-treatment.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 16
Est. completion date December 1, 2021
Est. primary completion date December 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Atopic dermatitis Exclusion Criteria: - Other inflammatory skin disease - Concurrent illness

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• narrow-band UVB
Standard established treatment for atopic dermatitis with narrow-band UVB will be used in this study but initially only on a small amount of skin to assess what changes takes place in the skin.

Locations
Country Name City State
Norway Oslo University Hospital Oslo

Sponsors (1)
Lead Sponsor Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Tintle S, Shemer A, Suárez-Fariñas M, Fujita H, Gilleaudeau P, Sullivan-Whalen M, Johnson-Huang L, Chiricozzi A, Cardinale I, Duan S, Bowcock A, Krueger JG, Guttman-Yassky E. Reversal of atopic dermatitis with narrow-band UVB phototherapy and biomarkers for therapeutic response. J Allergy Clin Immunol. 2011 Sep;128(3):583-93.e1-4. doi: 10.1016/j.jaci.2011.05.042. Epub 2011 Jul 16. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Early gene expression changes in atopic skin after UVB-treatment Gene expression changes Study period for each participant: 9 weeks
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