Keloid Pathogenesis And Fibroblast Activation Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe Fourth Affiliated Hospital of Zhejiang University School of Medicine
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Tissue Collection
Other interventionSurgical tissue collection only, no intervention
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Keloid Tissue Group1 intervention
Group B: Adjacent Normal Skin Group1 intervention
Trial outcomes
Primary outcomes
1
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 2028Secondary outcomes
1
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
2026-2028Sponsors and contacts
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Source ClinicalTrials.gov