Pathophysiological Basis of Hidradenitis Suppurativa

NCT06370052 | Not Yet Recruiting

• 1 other identifier: CHCRI-DJ-HS
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hidradenitis Suppurativa

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The expression of cytokines

  24 months

• The correlation of the clinical Hurley classification and pathohistological changes

  12 months

Study Arms (1)

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

Interventions

excision PROCEDURE

excision of the affected area

surgical procedure

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Hidradenitis Suppurativa

You may not qualify if:

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

Sponsors & Collaborators

• Clinical Hospital Center Rijeka: lead

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Study Officials

• Damir Juranić, MD

  surgeon at CHC Rijeka

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Damir Juranić, MD

CONTACT

+385915132034; damirjuranic@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: April 17, 2024
• Study Start: February 1, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: 24 months
• Access Criteria: According to the GDPR, we will give the information to other researchers upon request under "label anonymous" just to preserve patients' identity.