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The Effectiveness of Intralesional Botulinum Toxin A and Triamcinolone Acetonide Injections in Keloid Treatment

NCT06814288 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-02-07

No results posted yet for this study

Summary

Keloids are benign fibrous tissue overgrowths that extend beyond the boundaries of the original wound and tend to recur after therapy. The exact pathogenesis of keloids is not fully understood; however, the role of TGF-β leads to an imbalance in collagen synthesis and degradation, while VEGF increases vascularity. Enhanced vascularity contributes to increased fibroblast activity. Angiogenesis is heightened in wounds subjected to high tension. Active keloids are characterized by low vascular velocity, low elasticity, and varied echogenicity depending on the filling tissue, as observed on ultrasonographic examination. Intralesional TA injections at 40 mg/ml are an available option for keloids, but this therapy is associated with various side effects. Intralesional TB-A injections at 5 U/cm³ have been reported to demonstrate good efficacy, safety, tolerable side effects, and high patient satisfaction for keloid management. Therefore, it is necessary to conduct a study comparing the effectiveness of intralesional TB-A injections at 5 U/cm³ with intralesional TA injections at 40 mg/ml in keloid patients. Scar assessment can generally be conducted objectively using various tools or subjectively through different measurement scales. The Japan Scar Workshop (JSW) developed a measurement scale known as the JSW scar scale (JSS).

Conditions

  • Keloid Scars

Interventions

DRUG

Botulinum toxin A

Twenty keloid patients will be injected botulinum toxin A intralesional every 4 weeks.

DRUG

Triamcinolone Acetonide

Twenty keloid patients will be injected triamcinolone acetonide intralesional every 4 weeks.

Sponsors & Collaborators

  • Universitas Padjadjaran

    lead OTHER

Principal Investigators

  • Eva K sutedja, M.D. · Faculty of Medicine Universitas Padjadjaran

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2025-02-28
Completion
2025-03-01

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06814288 on ClinicalTrials.gov