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NCT Number: NCT07682636

Keloid Pathogenesis And Fibroblast Activation 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Jinhua, China

Location status: Recruiting

Location contact

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tissue collection

Other

Surgical tissue collection only, no intervention

Primary outcomes

  1. Expression Levels Of Fibrosis-Related Markers

    Time frame: Up to 2028

    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.

Secondary outcomes

  1. Histopathological Differences Between Keloid And Normal Skin

    Time frame: 2026-2028

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Other

Registry information

Official study title

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

Acronym: KPS

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jul 6, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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