To compare the microbiome, histology, immunohistochemistry and gene expression profile of healthy skin from the axillae or groin of 10 healthy volunteers with uninvolved axilla or groin skin from age, gender, body mass index, and smoking status…
ID
Source
Brief title
Condition
- Autoimmune disorders
- Skin appendage conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome:
The difference in gene expression profile of unaffected skin from the axillae
or groins of HS patients and healthy controls.
Secondary outcome
Secondary outcomes:
1. Microbial differences in uninvolved skin of HS axillae or groins and that of
healthy controls.
2. Histological and immunohistochemical differences in uninvolved skin of HS
axillae or groins and that of healthy controls
Background summary
Hidradenitis suppurativa (HS), is a chronic, recurrent, auto-inflammatory skin
disease located in the inverse areas of the body. The disease is characterized
by the development of inflammatory nodules, sinus tracts, scars and abscesses.
Multiple studies have sought to investigate the immune profile in HS comparing
lesional skin with uninvolved skin. However, until recent, there was no clear
definition what uninvolved skin entails, and it is unclear whether unaffected
skin from an HS predilection site can be readily assumed to be similar to
healthy skin. Therefore we aim to assess the microbial, histological, and
molecular differences between uninvolved skin of the axillae or groins of HS
patients and that of healthy controls.
Study objective
To compare the microbiome, histology, immunohistochemistry and gene expression
profile of healthy skin from the axillae or groin of 10 healthy volunteers with
uninvolved axilla or groin skin from age, gender, body mass index, and smoking
status matched HS patients undergoing surgery and from whom excised tissue is
available.
Study design
Explorative and experimental study design.
Study burden and risks
A skin biopsy is a generally safe routine dermatological diagnostic procedure,
however there is a small risk of bleeding and infection.
dr. Molewaterplein 40
Rotterdam 3015 GD
NL
dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, HS patients must meet all
of the following criteria:
- Adults (* 18 years old) suffering from HS
- Competent and willing to provide informed consent.
In order to be eligible to participate in this study, healthy controls must
meet all of the following criteria:
- Adults (* 18 years old) not suffering from HS
- Competent and willing to provide informed consent.
Exclusion criteria
Exclusion criteria for HS patients:
- Use of systemic or local antibiotics in the axillae or groin in the past 2
weeks
- Use of any other medication potentially affecting the immune system or
microbiome
Exclusion criteria for healthy controls:
- <18 years of age
- Presence of any inflammatory (skin) disease
- Positive family history of HS
- Use of systemic or local antibiotics in the axillae or groin in the past 2
weeks
- Use of any other medication potentially affecting the immune system
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 | NL72204.078.19 |