Atopic Dermatitis: Early Gene Expression Changes as Predictors of Therapeutic Response to Narrow-band UVB Treatment
1 other identifier
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 19, 2017
CompletedFirst Submitted
Initial submission to the registry
January 10, 2018
CompletedFirst Posted
Study publicly available on registry
January 18, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedMarch 2, 2021
March 1, 2021
4.2 years
January 10, 2018
March 1, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Early gene expression changes in atopic skin after UVB-treatment
Gene expression changes
Study period for each participant: 9 weeks
Study Arms (1)
Study Arm
EXPERIMENTALNarrow-band UVB will be given to a small part of the patients skin with eczema. The rest of the skin surface serves as control.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Atopic dermatitis
You may not qualify if:
- Other inflammatory skin disease
- Concurrent illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oslo University Hospital
Oslo, 0424, Norway
Related Publications (1)
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.
PMID: 21762976BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jan-Oivind Holm, MD, PhD
Oslo University Hospital/University of Oslo
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor and Consultant Dermatologist
Study Record Dates
First Submitted
January 10, 2018
First Posted
January 18, 2018
Study Start
September 19, 2017
Primary Completion
December 1, 2021
Study Completion
December 1, 2021
Last Updated
March 2, 2021
Record last verified: 2021-03