drugset / Trial / NCT06814288

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

NCT06814288

Phase 2 Active not recruiting 20 enrolled Padjadjaran University
RandomizedParallel-groupDouble-blindTreatment

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).

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Botulinum toxin type A Protein / enzyme biologic 5 unknown Other
Comparator Triamcinolone Acetonide Other / unclassified 40 mg/ml Other

Indications