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

Sponsor
Oslo University Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03402412
Collaborator
(none)
16
1
1
50.4
0.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: narrow-band UVB
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Atopic Dermatitis: Early Gene Expression Changes as Predictors of Therapeutic Response to Narrow-band UVB Treatment
Actual Study Start Date :
Sep 19, 2017
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Early gene expression changes in atopic skin after UVB-treatment [Study period for each participant: 9 weeks]

    Gene expression changes

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Atopic dermatitis
Exclusion Criteria:
  • Other inflammatory skin disease

  • Concurrent illness

Contacts and Locations

Locations

Site City State Country Postal Code
1 Oslo University Hospital Oslo Norway 0424

Sponsors and Collaborators

  • Oslo University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Jan Øivind Holm, Associate Professor and Consultant Dermatologist, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT03402412
Other Study ID Numbers:
  • 2017/466
First Posted:
Jan 18, 2018
Last Update Posted:
Mar 2, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 2, 2021