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Clinical and mechanistic studies of intralesional low-dose carrier-free 5-fluorouracil nanoparticles combined with surgical excision in the treatment of cutaneous scars

Clinical and mechanistic studies of intralesional low-dose carrier-free 5-fluorouracil nanoparticles combined with surgical excision in the treatment of cutaneous scars

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300071231
Enrollment
Unknown
Registered
2023-05-08
Start date
2023-05-12
Completion date
Unknown
Last updated
2023-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

keloid and hyperplastic scar

Interventions

experimental group:Carrier-free 5-fluorouracil+resection+radiotherapy
control group 1:Pure 5-fluorouracil + resection+radiotherapy
control group 2:Resection+radiotherapy

Sponsors

The Affiliated Hospital of Southwest Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. The course of disease is more than half a year; Scar is stable; It was confirmed that it was consistent with the morphological characteristics of hypertrophic scar and the diagnostic criteria of hypertrophic scar. For patients diagnosed with keloid, the scope of scar hyperplasia is beyond the original injured area and shows tumor growth, surgical treatment is proposed; 2. Aged range from 20 to 50 years; 3. This study was approved by the ethics committee of the hospital, and patients were informed of the possible advantages and disadvantages before and after medication in detail. Patients and their families voluntarily chose the treatment plan and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients planning to give birth in the near future, or women who are pregnant and breastfeeding; 2. Postoperative or previous injections to treat recurrent scars; 3. Signs of infection in scar; 4. Patients did not accept the treatment regimen set by the study; 5. The patient has systemic diseases that are not suitable for surgical resection.

Design outcomes

Primary

MeasureTime frame
gene sequencing;

Countries

China

Contacts

Public ContactLi Ying

Affiliated Hospital of Southwest Medical University

ly051118@163.com+86 18980250425

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026