Keloid Pathogenesis And Fibroblast Activation Study (KPS)

Mechanisms Of Keloid Fibroblast Activation And Potential Therapeutic Targets: A Tissue-Based Translational Study

Keloids are benign fibroproliferative skin disorders characterized by excessive fibroblast activation and extracellular matrix deposition. The molecular mechanisms underlying keloid formation remain incompletely understood. This prospective observational study aims to investigate the biological characteristics of keloid tissue by comparing surgically resected keloid specimens with adjacent normal skin obtained from the same patients. Histological and molecular analyses, including histopathology, polymerase chain reaction (PCR), Western blotting, and related laboratory assays, will be performed to identify signaling pathways and key regulatory factors associated with fibroblast activation. The findings may improve the understanding of keloid pathogenesis and identify potential therapeutic targets for future treatment.

Study Overview

• Status: Recruiting
• Conditions: Keloids; Fibroblast
• Intervention / Treatment: Other: Tissue Collection

Detailed Description

Background

Keloids are fibroproliferative disorders resulting from abnormal wound healing and are characterized by excessive fibroblast proliferation and abnormal collagen deposition. Although several signaling pathways, including transforming growth factor-beta (TGF-β), have been implicated in keloid development, the underlying molecular mechanisms remain incompletely understood.

Objectives

The primary objective of this study is to investigate the molecular mechanisms associated with abnormal fibroblast activation in keloids and to identify potential therapeutic targets by comparing keloid tissue with adjacent normal skin tissue.

Study Design

This is a prospective, single-center, observational study conducted at The Fourth Affiliated Hospital, Zhejiang University School of Medicine. Adult patients diagnosed with keloids and scheduled for surgical excision will be invited to participate after providing written informed consent.

Study Procedures

Residual surgical specimens, including keloid tissue and adjacent normal skin routinely removed during surgery, will be collected without any additional surgical procedures. Samples will be de-identified before laboratory analysis. Histological examination, gene expression analysis, protein expression analysis, and signaling pathway evaluation will be performed using standard laboratory techniques, including histopathology, PCR, and Western blotting.

Outcome Measures

The primary outcome is the differential expression of fibrosis-related signaling molecules and fibroblast activation markers between keloid tissue and normal skin. Secondary outcomes include histopathological differences, collagen deposition characteristics, and identification of potential molecular therapeutic targets.

Significance

This study is expected to improve understanding of the biological mechanisms underlying keloid formation and provide a scientific basis for the development of future targeted therapies.

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Wang; Phone Number: +86 18867961137; Email: wangshoujie@zju.edu.cn

Study Locations

• China
  • Jinhua, China
    • Recruiting
    • The Fourth Affiliated Hospital of Zhejiang University School of Medicine
    • Contact: Wang; Phone Number: +86 18867961137; Email: wangshoujie@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with clinically diagnosed keloids who are scheduled to undergo surgical excision at The Fourth Affiliated Hospital, Zhejiang University School of Medicine. Residual keloid tissue and adjacent normal skin tissue obtained during routine surgery will be used for laboratory analysis after written informed consent.

Description

Inclusion Criteria:

• Clinically diagnosed with keloid.
• Age 18 years or older.
• Scheduled to undergo surgical treatment at the study hospital.
• Able and willing to provide written informed consent.

Exclusion Criteria:

• Severe systemic disease.
• History of neurologic disease, alcoholism, postherpetic neuralgia, HIV infection, hypothyroidism, diabetes mellitus, or prior cancer chemotherapy.
• Other skin diseases within 5 cm of the keloid lesion, such as eczema.
• Systemic treatment within 7 days before enrollment or keloid-specific treatment within 6 weeks before enrollment, including intralesional corticosteroid injection, cryotherapy, topical medication, or silicone gel sheeting.
• Hormone or immunosuppressive therapy within 3 months before enrollment.
• Pregnancy or breastfeeding.
• Considered unsuitable for participation by the investigator.
• Refusal to participate in the study.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Keloid Tissue Group; Tissue samples obtained from keloid lesions excised during surgery from enrolled patients.	Other: Tissue Collection; Surgical tissue collection only, no intervention
Adjacent Normal Skin Group; Normal skin tissue obtained from the same patients during surgical procedures, used as internal control.	Other: Tissue Collection; Surgical tissue collection only, no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expression Levels Of Fibrosis-Related Markers	Comparison of expression levels of fibrosis-related and fibroblast activation markers (including TGF-β, α-SMA, collagen I, and related signaling molecules) between keloid tissue and adjacent normal skin using PCR, Western blot, and histological analysis.	Up to 2028

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histopathological Differences Between Keloid And Normal Skin	Evaluation of histological differences between keloid tissue and adjacent normal skin, including collagen deposition, fibroblast density, and tissue structure changes using hematoxylin and eosin staining.	2026-2028

Collaborators and Investigators

• Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2025
• Primary Completion (Estimated): May 10, 2028
• Study Completion (Estimated): May 30, 2028

Study Registration Dates

• First Submitted: June 28, 2026
• First Submitted That Met QC Criteria: June 28, 2026
• First Posted (Actual): July 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: June 28, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Connective Tissue Diseases; Cicatrix; Fibrosis; Collagen Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Keloid; Health Care Facilities Workforce and Services; Biological Specimen Banks; Health Facilities; Tissue Banks
• Other Study ID Numbers: KY-2026-115 (Other Identifier: The Fourth Affiliated Hospital, Zhejiang University School of Medicine)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO