Mechanisms Of Keloid Fibroblast Activation And Potential Therapeutic Targets: A Tissue-Based Translational Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Expression Levels Of Fibrosis-Related Markers
Study Overview
Brief 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.
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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
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
- Histopathological Differences Between Keloid And Normal Skin(2026-2028)