The Effectiveness of Intralesional Botulinum Toxin A and Triamcinolone Acetonide Injections in Ke… (NCT06814288) | Clinical Trial Compass
Active — Not RecruitingPhase 2
The Effectiveness of Intralesional Botulinum Toxin A and Triamcinolone Acetonide Injections in Keloid Treatment
Indonesia20 participantsStarted 2024-05-01
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Female and male patients aged ≥ 18 years.
✓. Patients clinically diagnosed with keloids.
✓. Patients with at least two keloid lesions located on different sides but in similar anatomical regions.
✓. Keloid lesion size is limited to ≤ 5 cm².
✓. All keloid patients who will not undergo other keloid treatments (surgical excision, chemotherapy injections, laser therapy, radiation therapy, cryotherapy, or pressure therapy) during the study and observation period.
✓. All keloid patients who have not undergone any keloid treatment in the past two months.
Exclusion criteria
✕. Pregnant and breastfeeding women.
✕. Patients currently using hormonal contraceptives.
✕. Use of or exposure to aminoglycosides, lincosamides, polymyxins, quinine, magnesium sulfate, anticholinesterases, succinylcholine, or other serotypes of botulinum toxin.
✕. Presence of motor peripheral neuropathy (e.g., amyotrophic lateral sclerosis or motor neuropathy), neuromuscular junction disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome), diabetes mellitus, or uncontrolled cardiovascular disorders.