To investigate the changes in the skin immune system after 12 weeks of biologic therapy treatment in patients with HS.
ID
Source
Brief title
Condition
- Skin appendage conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the change in gene expression profile in lesional,
peri-lesional an uninvolved skin in patients with HS after 12 weeks of biologic
treatment.
Secondary outcome
- Microbial changes profile in lesional, peri-lesional an uninvolved skin in
patients with HS after 12 weeks of biologic treatment.
- Immunohistochemical changes profile in lesional, peri-lesional an uninvolved
skin in patients with HS after 12 weeks of biologic treatment.
- Change in protein expression profile in lesional, peri-lesional an
uninvolved skin in patients with HS after 12 weeks of biologic treatment.
Background summary
Hidradenitis suppurativa has a complex immune driven pathogenesis involving a
wide variety of immune cells, chemokines and cytokines. However, to what extent
which pathways among this complex interplay of immune cells and cytokines are
altered by biologic therapy is remains unclear.
Study objective
To investigate the changes in the skin immune system after 12 weeks of biologic
therapy treatment in patients with HS.
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
1. Age *18 years.
2. Indication for and starting with a biologic.
3. Able and willing to give written informed consent and to comply with the
study requirements.
Exclusion criteria
1. Use of any medication potentially affecting the skin immune system or skin
microbiome.
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 | NL72653.078.20 |