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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Keloid Scars
• Intervention / Treatment: Drug: Botulinum toxin A; Drug: Triamcinolone Acetonide

Detailed Description

This study aims to evaluate the effectiveness of intralesional TB-A injections at 5 U/cm³ compared to intralesional TA injections at 40 mg/ml in keloid patients in Indonesia, assessed using the Japan Scar Scale (JSS) and measurements of lesion volume, vascularization degree, vascular velocity, elasticity, and echogenicity through high-resolution ultrasonography. Such research has not been conducted before.

The study design is an experimental single-blind randomized trial with a pretest-posttest design. Participants include keloid patients seeking treatment at the Tumor and Dermatologic Surgery Clinic, Department of Dermatology and Venereology, RSHS Bandung, who meet the inclusion and exclusion criteria. Lesions and treatments are randomized by the researchers, and the selected treatment is then administered to the keloid lesions. Observations are repeated to evaluate the effectiveness of the therapy using JSS and high-resolution ultrasonography.

During patient visits, the following procedures are conducted:

History Taking and Physical Examination Patients undergo anamnesis and a thorough physical examination.

Baseline Keloid Lesion Measurement Initial lesion measurements are performed using a caliper to establish baseline data before therapy.

Elasticity Measurement Baseline lesion elasticity is measured using the Cutometer MPA 580 at the midpoint of each lesion. Skin erythema is assessed using the CM-700d Spectrophotometer.

High-Resolution Ultrasonography Assessment

A radiology specialist performs the ultrasonography using a Phillips EPIQ Elite® high-resolution ultrasound device with a linear transducer at 22 MHz. The machine's automatic settings for observing superficial structures are applied uniformly across cases.

Patients are positioned upright or lying down, depending on lesion location. The transducer is placed perpendicularly to the keloid lesion in both transverse and longitudinal orientations without applying pressure.

Measurements include lesion volume, vascularization degree, vascular velocity, elasticity, and echogenicity type.

Documentation involves recording data and capturing images on the ultrasound machine.

Photographic Documentation Lesions are photographed from the top and side for documentation.

Randomization and Group Assignment

Lesions are randomly assigned to one of two therapy groups:

Group I: Intralesional Botulinum Toxin A injection at 5 U/cm³. Group II: Intralesional Triamcinolone Acetonide injection at 40 mg/ml. These detailed procedures ensure a comprehensive evaluation of the comparative efficacy of the two treatments in managing keloid lesions.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• Indonesia
  • Jawa Barat
    • Bandung, Jawa Barat, Indonesia, 20161
      • Hasan Sadikin General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Female and male patients aged ≥ 18 years.
2. Patients clinically diagnosed with keloids.
3. Patients with at least two keloid lesions located on different sides but in similar anatomical regions.
4. Keloid lesion size is limited to ≤ 5 cm².
5. 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.
6. All keloid patients who have not undergone any keloid treatment in the past two months.

Exclusion Criteria:

1. Pregnant and breastfeeding women.
2. Patients currently using hormonal contraceptives.
3. Patients undergoing long-term systemic corticosteroid therapy.
4. History of hypersensitivity to botulinum toxin.
5. Use of or exposure to aminoglycosides, lincosamides, polymyxins, quinine, magnesium sulfate, anticholinesterases, succinylcholine, or other serotypes of botulinum toxin.
6. 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.
7. Infection at the injection site.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Botulinum Toxin A; Twenty keloid patients will be injected botulinum toxin A intralesional every 4 weeks.	Drug: Botulinum toxin A; Twenty keloid patients will be injected botulinum toxin A intralesional every 4 weeks.
Active Comparator: Triamcinolone Acetonide; Twenty keloid patients will be injected triamcinolone acetonide intralesional every 4 weeks.	Drug: Triamcinolone Acetonide; Twenty keloid patients will be injected triamcinolone acetonide intralesional every 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Japan Scar Workshop Scar Scale (JSS)	Evaluation for Groups I and II is conducted every four weeks, specifically in the 4th, 8th, and 12th weeks. At each visit, assessments of JSS for evaluation consists of six items: (1) Induration, (2) Elevation, (3) Redness of the scar, (4) Erythema around the scar, (5) Spontaneous and pressing pain, and (6) Itch. Each item has four intensity categories, namely, None, Weak, Mild, and Strong. These categories are weighted 0, 1, 2, and 3, respectively. There are sample images of each category in each item that helps the user judge the items. The minimum and maximum total points in the evaluation table are thus 0 and 18, respectively. When the symptoms improve, the total score decreases.	12 weeks
Lesion volume by ultrasonography	Lesion volume in mililiters (ml) are measured by high-resolution ultrasonography on the initial visit (before therapy) and week-12 (after therapy)	12 weeks
Elasticity	Elasticity ratio between keloid lesion and normal skin are measured by cutometer and high-resolution ultrasonography on the initial visit (before therapy) and week-12 (after therapy)	12 weeks
Echogenicity on ultrasonography	Echogenicity of keloid lesion are measured by high-resolution ultrasonography on the initial visit (before therapy) and week-12 (after therapy)	12 weeks
Degree of Vascularity on ultrasonography	Degree of Vascularity of keloid lesion are measured by high-resolution ultrasonography on the initial visit (before therapy) and week-12 (after therapy)	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale (VAS) after every injection session	Evaluation for Groups I and II is conducted every four weeks, specifically in the 4th, 8th, and 12th weeks. At each visit, assessments of VAS for therapy evaluation	12 weeks
Adverse Effects	Evaluation of any adverse effects for Groups I and II is conducted every four weeks, specifically in the 4th, 8th, and 12th weeks	12 weeks

Collaborators and Investigators

• Sponsor: Universitas Padjadjaran
• Investigators: Principal Investigator: Eva K sutedja, M.D., Faculty of Medicine Universitas Padjadjaran

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Estimated): February 28, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: February 3, 2025
• First Submitted That Met QC Criteria: February 3, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 3, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Botulinum Toxin A; Keloid; Triamcinolone Acetonide; Intralesional Injection
• Additional Relevant MeSH Terms: Pathologic Processes; Connective Tissue Diseases; Cicatrix; Fibrosis; Collagen Diseases; Keloid; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Enzyme Inhibitors; Neurotransmitter Agents; Membrane Transport Modulators; Cholinergic Agents; Neuromuscular Agents; Acetylcholine Release Inhibitors; Botulinum Toxins, Type A; abobotulinumtoxinA; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate; Botulinum Toxins
• Other Study ID Numbers: DV-202501.01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No