Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06370052
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-03-20
Brief Title:
Pathophysiological Basis of Hidradenitis Suppurativa
Sponsor:
Clinical Hospital Center Rijeka
Organization:
Clinical Hospital Center Rijeka
Study Overview
Official Title:
Pathophysiological Basis of Hidradenitis Suppurativa
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
HS is a chronic inflammatory disease manifested by recurrent inflammatory nodules abscesses and tunnels under the skin This disease is characterized by an inflammatory process that takes place in hair follicles sebaceous glands and surrounding tissue Because of its frequent recurrence and chronicity it represents a major public health problem and there is a need for better diagnosis and new and more effective drugs This research can be a part of realizing the stated needs
Detailed Description:
HS patients divided into three groups depending on the stage of hidradenitis would participate in the study
The first and second groups would include stage 2-3 patients according to the Hurley scale in whom partial or complete clinical remission occurred after biological therapy and surgical treatment was performed according to the guidelines
In the third control group we would classify the samples obtained from the above-mentioned patients from whom we would take a sample of normal skin measuring 1 x 1 cm
With the standard procedure of pathohistological tissue processing after tissue fixation with 10 buffered formalin and embedding in paraffin tissue sections stained with standard hematoxylin and eosin HE staining will be analyzed using a light microscope in such a way as to determine the type and amount of inflammatory infiltrate the amount of granulation tissue and fibrosis and epithelial changes of the surface and follicular epithelium and graded according to intensity into 3 categories
The mentioned tissue samples fixed in formalin and embedded in paraffin will be used to make tissue sections for immunohistochemical staining The expression of inflammatory cytokines will be analyzed using the indirect peroxidase immunohistochemical method Primary and secondary antibodies will be used for immunohistochemical analyses The prepared tissue sections will be deparaffinized in a xylene solution and then dehydrated in a series of ethyl alcohols of decreasing concentrations 100 96 and 75 It will then be washed three times with PBS solution and in citrate buffer 10mM pH 60 Sections will then be washed with Triton X 100 solution 03 in PBS at room temperature After that endogenous peroxidase will be inactivated using hydrogen peroxide in methanol 03 for 30 minutes After washing the tissue sections with PBS solution normal serum 10 will be added for 60 minutes After washing the tissue sections in PBS solution pH 74 the secondary antibody will be added depending on the primary one Tissue rehydration will be done in ethyl alcohols of increasing concentrations 75 96 and 100 After clarification with xylol the preparation will be incorporated into entalan
The intensity of immunohistochemical staining will be analyzed using the ImageJ computer program according to the staining intensity
The first and second groups would include stage 2-3 patients according to the Hurley scale in whom partial or complete clinical remission occurred after biological therapy and surgical treatment was performed according to the guidelines
In the third control group we would classify the samples obtained from the above-mentioned patients from whom we would take a sample of normal skin measuring 1 x 1 cm
With the standard procedure of pathohistological tissue processing after tissue fixation with 10 buffered formalin and embedding in paraffin tissue sections stained with standard hematoxylin and eosin HE staining will be analyzed using a light microscope in such a way as to determine the type and amount of inflammatory infiltrate the amount of granulation tissue and fibrosis and epithelial changes of the surface and follicular epithelium and graded according to intensity into 3 categories
The mentioned tissue samples fixed in formalin and embedded in paraffin will be used to make tissue sections for immunohistochemical staining The expression of inflammatory cytokines will be analyzed using the indirect peroxidase immunohistochemical method Primary and secondary antibodies will be used for immunohistochemical analyses The prepared tissue sections will be deparaffinized in a xylene solution and then dehydrated in a series of ethyl alcohols of decreasing concentrations 100 96 and 75 It will then be washed three times with PBS solution and in citrate buffer 10mM pH 60 Sections will then be washed with Triton X 100 solution 03 in PBS at room temperature After that endogenous peroxidase will be inactivated using hydrogen peroxide in methanol 03 for 30 minutes After washing the tissue sections with PBS solution normal serum 10 will be added for 60 minutes After washing the tissue sections in PBS solution pH 74 the secondary antibody will be added depending on the primary one Tissue rehydration will be done in ethyl alcohols of increasing concentrations 75 96 and 100 After clarification with xylol the preparation will be incorporated into entalan
The intensity of immunohistochemical staining will be analyzed using the ImageJ computer program according to the staining intensity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None