Objective: To compare histology, gene expression profile (using transcriptome analysis and quantitative Polymerase Chain Reaction (qPCR) validation) and the microbiome of vesicular endogenous hand eczema between and within patients and to skin of…
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To compare the gene expression profile of vesicular endogenous hand eczema
(using transcriptome data and validation with quantitative Polymerase Chain
Reaction (qPCR)) in non-lesional and early vesicular skin between and within
cases and to healthy controls.
Secondary outcome
- Protein expression: to further explore the findings from transcriptome
analysis in immunohistochemistry experiments on skin taken from patients with
vesicular endogenous hand eczema and healthy controls.
- To compare histologic morphology of vesicular endogenous hand eczema between
and within cases and to healthy controls.
- To compare microbiome colonization profile between and within cases and to
healthy controles.
Background summary
Rationale: Hand eczema is a common disease. Many studies on its treatment have
been carried out. Remarkably, surprisingly little research has been done on its
pathogenesis. More insight into the disease on a more fundamental level should
lead to a better understanding of the biological processes involved, as well as
new avenues for the development of treatment strategies. The subtype of
vesicular endogenous hand eczema is well characterized and grants the
opportunity to follow the development of disease morphology quite clearly.
Study objective
Objective: To compare histology, gene expression profile (using transcriptome
analysis and quantitative Polymerase Chain Reaction (qPCR) validation) and the
microbiome of vesicular endogenous hand eczema between and within patients and
to skin of healthy controls.
Study design
Study design: Observational case-control study.
Method: From cases, two five-millimetre skin punch biopsy samples will be
collected during the course of one vesicular hand eczema episode: (1)
non-lesional skin; (2) skin with visible vesicles, but without other signs of
inflammation. From controls, one five-millimetre skin punch biopsy sample will
be collected from the hypothenar region of the non-dominant hand. Also, swabs
will be taken from the palms of the hands of subject with hand eczema and
healthy subjects.
Study burden and risks
Both participants in the case group and participants in the control group need
to visit only once. Skin biopsies will be performed. This is a standard
dermatological procedure, performed on a daily base. It is a generally safe
procedure with minimal burden to the patient. Biopsies can be mainly associated
with a small risk of scarring, prolonged bleeding and/or infection.
Furthermore, photographs will be taken of the participants hands before taking
the skin biopsy. This poses no extra risk. Patients will be compensated for
their costs and will additionally receive a compensation for participating in
the study.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
• Age >= 18 years and <= 70 years
• Dutch parents and a white (Caucasian) skin tone
• No concomitant diagnose of atopic dermatitis (current), as defined by the UK Working Party Criteria
• For the case group:
o Vesicular endogenous hand eczema as defined by the Danish Contact Dermatitis Group and current guidelines
o Show both non-lesional skin and skin with visible early vesicles, but without other signs of inflammation, at time of inclusion
• For the control group (to be included after completion of the case group):
o 2 males and 2 females with the average age of cases
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
• Immunosuppressive or immunomodulatory treatment within the last 2 weeks
• UV radiation therapy within 4 weeks before biopsy
• Active bacterial, fungal or viral infection of the hands
• Other skin diseases of the hands
• Mentally incompetent: patient is unable to make important decisions regarding his or her affairs (to be determined by investigator or treating physician)
• Proven contact sensitization with clinical relevance to the hands, in which exposure to allergens is not avoided
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL64339.042.17 |