Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT06814288
PHASE2

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

Sponsor: Universitas Padjadjaran

View on ClinicalTrials.gov

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).

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2024-05-01

Completion Date

2025-03-01

Last Updated

2025-02-07

Healthy Volunteers

No

Conditions

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.

Locations (1)

Hasan Sadikin General Hospital

Bandung, West Java, Indonesia