Botulinum Toxins Intralesional Injection for Scar Pain

Intralesional Injection of Steroids and/or Botulinum Toxin Type A in Hypertrophic Scars and Keloids for Pain Improvement

Botulinum toxins has been approved by the FDA to treat chronic migraine. Botox had been shown to inhibiting the release of inflammatory mediators and peripheral neurotransmitters from sensory nerve to treat neuropathic pain. In the clinical practice, botox indeed effect in scar pain. However, investigators need well controlled study to prove this finding and assess the improvement of scar appearance.

Study Overview

• Status: Unknown
• Conditions: Hypertrophic Scar; Scar Keloid
• Intervention / Treatment: Drug: Triamcinolone; Drug: Lidocaine; Drug: Botulinum toxin A

Detailed Description

After surgery or trauma, scar tissues would form during the healing process. However, hypertrophic scars and keloids might happen to some patients, both of which are often pruritic and erythematous. Besides, the markedly elevated tumor-like appearance usually brings much concern to patients. Moreover, significant pain or discomfort could happen to keloids. Various treatment strategies were mentioned but without a solid solution to all of the scars. Investigators hope to evaluate the differences of scar volume, appearance and symptoms (itching and pain) in participants receiving simultaneous intralesional injection of Botulinum toxin type A and/or steroids. Besides, side effects would also be recorded. Investigators hope to establish a more effective intralesional injection therapy for participatns suffering from hypertrophic scars and keloids.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Shu Hung Huang, MD, PHD; Phone Number: 6866 886-3121101; Email: huangsh63@gmail.com

Study Locations

• Taiwan
  • Kaohsiung, Taiwan
    • Recruiting
    • Kaohsiung Medical University Hospital
    • Contact: Shu Hung Huang, MD, PHD; Phone Number: 6866 886-3121101; Email: huangsh63@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients have visible hypertrophic scars or keloids over three months after trauma or surgery.
2. Patients have symptoms of pain, itching or erythema.

Exclusion Criteria:

1. Patients had either Botulinum toxin type A or Triamcinolone intralesional before in the same scar
2. The scar size is larger than 10 cm2
3. Immunocompromised status
4. Systemic infection status
5. Allergic to Botulinum toxin type A or steroids

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control group; 0.9% Normal saline 0.1 ml +Triamcinolone 4mg diluted to 0.1 ml + 0.1ml 2% Xylocaine per 1cm2 scar volume	Drug: Triamcinolone; Triamcinolone 4mg diluted to 0.1 ml; Other Names: steroid; Drug: Lidocaine; 0.1ml 2% Xylocaine; Other Names: Xylocaine
Experimental: botox group; 4U Botox® diluted to 0.1 ml + Triamcinolone 4mg diluted to 0.1 ml + 0.1ml 2% Xylocaine per 1 cm2 scar volume	Drug: Triamcinolone; Triamcinolone 4mg diluted to 0.1 ml; Other Names: steroid; Drug: Lidocaine; 0.1ml 2% Xylocaine; Other Names: Xylocaine; Drug: Botulinum toxin A; 4U Botox® diluted to 0.1 ml; Other Names: botox

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scar pain relief	assessed by score 0,1,2 (0: no pain, 1: sometimes feel pain, 2: need medication)	Change from baseline scar pain during 16 weeks after drug injection
scar appearance	assessed by vancouver scar scale(vascularity, pigmentation, pliability, height)	Change from baseline scar appearance during 16 weeks after drug injection
itch	assessed by score 0,1,2 (0: no itch, 1: sometimes feel itch, 2: need medication)	Change from baseline itch sensation during 16 weeks after drug injection

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University
• Investigators: Study Director: Shu Hung Huang, MD, PHD, Kaohsiung Medical University

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2018
• Primary Completion (Anticipated): June 30, 2019
• Study Completion (Anticipated): June 30, 2019

Study Registration Dates

• First Submitted: June 9, 2019
• First Submitted That Met QC Criteria: June 11, 2019
• First Posted (Actual): June 12, 2019

Study Record Updates

• Last Update Posted (Actual): June 17, 2019
• Last Update Submitted That Met QC Criteria: June 13, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Triamcinolone; Botulinum toxin type A; scar pain; scar itch
• Additional Relevant MeSH Terms: Pathologic Processes; Connective Tissue Diseases; Pathological Conditions, Anatomical; Fibrosis; Collagen Diseases; Hypertrophy; Cicatrix; Keloid; Cicatrix, Hypertrophic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Cholinergic Agents; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Acetylcholine Release Inhibitors; Neuromuscular Agents; Lidocaine; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA; Triamcinolone
• Other Study ID Numbers: KMUHIRB-F(II)-20180062

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No