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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Other: narrow-band UVB

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0424
    • Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Atopic dermatitis

Exclusion Criteria:

• Other inflammatory skin disease
• Concurrent illness

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Arm; Narrow-band UVB will be given to a small part of the patients skin with eczema. The rest of the skin surface serves as control.	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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Principal Investigator: Jan-Oivind Holm, MD, PhD, Oslo University Hospital/University of Oslo

Publications and helpful links

General Publications

• Tintle S, Shemer A, Suarez-Farinas 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2017
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: January 10, 2018
• First Submitted That Met QC Criteria: January 17, 2018
• First Posted (Actual): January 18, 2018

Study Record Updates

• Last Update Posted (Actual): March 2, 2021
• Last Update Submitted That Met QC Criteria: March 1, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: 2017/466

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No