An observational study in Keloids and Fibroblast, sponsored by The Fourth Affiliated Hospital of Zhejiang University School of Medicine. Recruiting at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by The Fourth Affiliated Hospital of Zhejiang University School of Medicine · Observational
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.
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.
138 studies on the registry are indexed under Keloid; 26 are open to participants now.
This study's planned enrollment of 20 is below the median of 100 across 23 observational studies indexed under Keloid.
Browse Keloid studies →The Fourth Affiliated Hospital of Zhejiang University School of Medicine is the lead sponsor of 92 studies on the registry; 78 are open to participants now.
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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.
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Exclusion Criteria:
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The human immunodeficiency virus, which weakens the immune system.
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Tissue samples obtained from keloid lesions excised during surgery from enrolled patients.
Other: Tissue Collection
Normal skin tissue obtained from the same patients during surgical procedures, used as internal control.
Other: Tissue Collection
Surgical tissue collection only, no intervention
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.
Time frame: Up to 2028
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.
Time frame: 2026-2028
Plan to share: No
No publications or documents are linked to this record.
Started May 2025 (actual). Primary completion is estimated for May 2028, 36 months after the start.
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The Fourth Affiliated Hospital of Zhejiang University School of Medicine