Botulinum Toxins Intralesional Injection for Scar Pain

Phase 4

• Conditions: Scar Keloid; Hypertrophic Scar
• Interventions: Drug: Triamcinolone; Drug: Lidocaine; Drug: Botulinum toxin A

• Registration Number: NCT03982862
• Lead Sponsor: Kaohsiung Medical University

Brief Summary

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.

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 Timeline

• Study Start: 2018-07-30
• Status Verified: 2019-06
• Study First Submitted: 2019-06-09
• Study First Submitted QC: 2019-06-11
• Study First Posted: 2019-06-12
• Last Update Submitted: 2019-06-13
• Last Update Posted: 2019-06-17
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
botox group	Lidocaine	4U Botox® diluted to 0.1 ml + Triamcinolone 4mg diluted to 0.1 ml + 0.1ml 2% Xylocaine per 1 cm2 scar volume
control group	Lidocaine	0.9% Normal saline 0.1 ml +Triamcinolone 4mg diluted to 0.1 ml + 0.1ml 2% Xylocaine per 1cm2 scar volume
botox group	Triamcinolone	4U Botox® diluted to 0.1 ml + Triamcinolone 4mg diluted to 0.1 ml + 0.1ml 2% Xylocaine per 1 cm2 scar volume
control group	Triamcinolone	0.9% Normal saline 0.1 ml +Triamcinolone 4mg diluted to 0.1 ml + 0.1ml 2% Xylocaine per 1cm2 scar volume
botox group	Botulinum toxin A	4U Botox® diluted to 0.1 ml + Triamcinolone 4mg diluted to 0.1 ml + 0.1ml 2% Xylocaine per 1 cm2 scar volume

Primary Outcome Measures

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

Trial Locations

Locations (1)

Kaohsiung Medical University Hospital; 🇨🇳 Kaohsiung, Taiwan