Botulinum Toxins Intralesional Injection for Scar Pain

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Scar Keloid, Hypertrophic Scar

Intervention / Treatment
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* Drug: Triamcinolone
* Drug: Lidocaine
* Drug: Botulinum toxin A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients have visible hypertrophic scars or keloids over three months after trauma or surgery. Patients have symptoms of pain, itching or erythema. Exclusion Criteria: Patients had either Botulinum toxin type A or Triamcinolone intralesional before in the same scar The scar size is larger than 10 cm2 Immunocompromised status Systemic infection status Allergic to Botulinum toxin type A or steroids

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Botulinum toxin type A, Triamcinolone, scar pain, scar itch