Keloid Pathogenesis And Fibroblast Activation Study

NCT07682636 | Recruiting

• 1 other identifier: KY-2026-115
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Keloids; Fibroblast

Outcome Measures

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.

  Up to 2028

Secondary Outcomes (1)

• Histopathological Differences Between Keloid And Normal Skin

  2026-2028

Study Arms (2)

Keloid Tissue Group

Tissue samples obtained from keloid lesions excised during surgery from enrolled patients.

Other: Tissue Collection

Adjacent Normal Skin Group

Normal skin tissue obtained from the same patients during surgical procedures, used as internal control.

Other: Tissue Collection

Interventions

Tissue Collection OTHER

Surgical tissue collection only, no intervention

Adjacent Normal Skin Group; Keloid Tissue Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Fourth Affiliated Hospital of Zhejiang University School of Medicine: lead

Study Sites (1)

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Jinhua, China

RECRUITING

MeSH Terms

Conditions

Keloid

Interventions

Tissue Banks

Condition Hierarchy (Ancestors)

Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Specimen Banks; Health Facilities; Health Care Facilities Workforce and Services

Central Study Contacts

Wang

CONTACT

+86 18867961137; wangshoujie@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2026
• First Posted: July 6, 2026
• Study Start: May 10, 2025
• Primary Completion (Estimated): May 10, 2028
• Study Completion (Estimated): May 30, 2028
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)