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

NCT06814288 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: DV-202501.01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Keloid; Botulinum Toxin A; Triamcinolone Acetonide; Intralesional Injection

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Visual Analogue Scale (VAS) after every injection session

  12 weeks

• Adverse Effects

  12 weeks

Study Arms (2)

Botulinum Toxin A

EXPERIMENTAL

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

Drug: Botulinum toxin A

Triamcinolone Acetonide

ACTIVE COMPARATOR

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

Drug: Triamcinolone Acetonide

Interventions

Botulinum toxin A DRUG

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

Botulinum Toxin A

Triamcinolone Acetonide DRUG

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

Triamcinolone Acetonide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant and breastfeeding women.
• Patients currently using hormonal contraceptives.
• Patients undergoing long-term systemic corticosteroid therapy.
• History of hypersensitivity to botulinum toxin.
• 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.
• Infection at the injection site.

Sponsors & Collaborators

• Universitas Padjadjaran: lead

Study Sites (1)

Hasan Sadikin General Hospital

Bandung, West Java, 20161, Indonesia

Location

MeSH Terms

Conditions

Keloid

Interventions

Botulinum Toxins, Type A; Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Eva K sutedja, M.D.

  Faculty of Medicine Universitas Padjadjaran

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 7, 2025
• Study Start: May 1, 2024
• Primary Completion: February 28, 2025
• Study Completion: March 1, 2025
• Last Updated: February 7, 2025

Record last verified: 2025-02

Locations

ID (1)