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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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

20

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

      • Jinhua, Kina
        • Rekrytering
        • The Fourth Affiliated Hospital of Zhejiang University School of Medicine
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
Keloid Tissue Group
Tissue samples obtained from keloid lesions excised during surgery from enrolled patients.
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.
Surgical tissue collection only, no intervention

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Expression Levels Of Fibrosis-Related Markers
Tidsram: 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.
Up to 2028

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Histopathological Differences Between Keloid And Normal Skin
Tidsram: 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.
2026-2028

Samarbetspartners och utredare

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Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

10 maj 2025

Primärt slutförande (Beräknad)

10 maj 2028

Avslutad studie (Beräknad)

30 maj 2028

Studieregistreringsdatum

Först inskickad

28 juni 2026

Först inskickad som uppfyllde QC-kriterierna

28 juni 2026

Första postat (Faktisk)

6 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

28 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • KY-2026-115 (Annan identifierare: The Fourth Affiliated Hospital, Zhejiang University School of Medicine)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

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