Keloid Pathogenesis And Fibroblast Activation Study

NCT07682636 — Recruiting, 20 participants, The Fourth Affiliated Hospital of Zhejiang University School of Medicine

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

RegistryNCT07682636, acronym KPS
StatusRecruiting
Study typeObservational
Enrollment20 (Estimated)
SponsorThe Fourth Affiliated Hospital of Zhejiang University School of Medicine (Other)
ConditionsKeloids, Fibroblast
InterventionsTissue Collection (Other)
Datesstart 2025-05-10, primary completion 2028-05-10 (estimated), completion 2028-05-30 (estimated), first posted 2026-07-06, last updated 2026-07-06
Locations1 site in China

Related Papers Related Patents Related Grants Related Experts
All trials for Keloids All trials for Fibroblast All trials of Tissue Collection

-Summary

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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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Keloid Tissue GroupOther: Tissue CollectionTissue samples obtained from keloid lesions excised during surgery from enrolled patients.
Adjacent Normal Skin GroupOther: Tissue CollectionNormal skin tissue obtained from the same patients during surgical procedures, used as internal control.
  • Tissue Collection (Other): Surgical tissue collection only, no intervention

+Outcome measures

Primary outcomes

  • Expression Levels Of Fibrosis-Related Markers [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

  • Histopathological Differences Between Keloid And Normal Skin [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.

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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.

+Locations (1)

FacilityCityCountryStatus
The Fourth Affiliated Hospital of Zhejiang University School of MedicineJinhuaChinaRecruiting