Botulinum Toxins Intralesional Injection for Scar Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-30

Study Completion Date

2019-06-30

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.

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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.

Conditions

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Scar Keloid Hypertrophic Scar

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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control group

0.9% Normal saline 0.1 ml +Triamcinolone 4mg diluted to 0.1 ml + 0.1ml 2% Xylocaine per 1cm2 scar volume

Group Type ACTIVE_COMPARATOR

Triamcinolone

Intervention Type DRUG

Triamcinolone 4mg diluted to 0.1 ml

Lidocaine

Intervention Type DRUG

0.1ml 2% Xylocaine

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

Group Type EXPERIMENTAL

Triamcinolone

Intervention Type DRUG

Triamcinolone 4mg diluted to 0.1 ml

Lidocaine

Intervention Type DRUG

0.1ml 2% Xylocaine

Botulinum toxin A

Intervention Type DRUG

4U Botox® diluted to 0.1 ml

Interventions

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Triamcinolone

Triamcinolone 4mg diluted to 0.1 ml

Intervention Type DRUG

Lidocaine

0.1ml 2% Xylocaine

Intervention Type DRUG

Botulinum toxin A

4U Botox® diluted to 0.1 ml

Intervention Type DRUG

Other Intervention Names

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steroid Xylocaine botox

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No