Pathophysiological Basis of Hidradenitis Suppurativa

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hidradenitis Suppurativa
• Intervention / Treatment: Procedure: excision

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 6.0). Sections will then be washed with Triton X 100 solution (0.3% in PBS) at room temperature. After that, endogenous peroxidase will be inactivated using hydrogen peroxide in methanol (0.3%) 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 7.4), 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 Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Damir Juranić, MD; Phone Number: +385915132034; Email: damirjuranic@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patiens with HS that are controlled in the region of CHC Rijeka

Description

Inclusion Criteria:

• Hidradenitis Suppurativa

Exclusion Criteria:

• patients with no HS
• patients who do not want to be in the clinical trial

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

surgical procedure; 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. GOAL: To determine the pathohistological changes in skin and subcutaneous tissues of patients with HS Hurley stage I and II and healthy patients (control group) and compare them with each other.

Procedure: excision; excision of the affected area

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The pathohistological changes	The pathohistological changes in skin and subcutaneous tissues of patients with HS Hurley stage I and II and healthy patients (control group) will be assessed and compared them with each other.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The expression of cytokines	The expression of IL-1β, TNF-α, IL-8 and IL-10 by immunohistochemical method in skin and subcutaneous tissue of patients with HS Hurley stage II and III and healthy patients (control group) will be assessed and compared with each other	24 months
The correlation of the clinical Hurley classification and pathohistological changes	The clinical Hurley classification and pathohistological changes in the removed skin are meant to be correlated	12 months

Collaborators and Investigators

• Sponsor: Clinical Hospital Center Rijeka
• Investigators: Principal Investigator: Damir Juranić, MD, surgeon at CHC Rijeka

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 20, 2024
• First Submitted That Met QC Criteria: April 13, 2024
• First Posted (Actual): April 17, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 14, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Skin Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Sweat Gland Diseases; Skin Diseases, Bacterial; Skin Diseases, Infectious; Suppuration; Hidradenitis Suppurativa; Hidradenitis
• Other Study ID Numbers: CHCRI-DJ-HS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Yes
• IPD Sharing Time Frame: 24 months
• IPD Sharing Access Criteria: According to the GDPR, we will give the information to other researchers upon request under "label anonymous" just to preserve patients' identity.
• IPD Sharing Supporting Information Type: ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No