Botulinum Toxins Intralesional Injection for Scar Pain

Kaohsiung Medical University20 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Scar Keloid Hypertrophic Scar

Interventions

TriamcinoloneDRUG

Triamcinolone 4mg diluted to 0.1 ml

LidocaineDRUG

0.1ml 2% Xylocaine

Botulinum toxin ADRUG

4U Botox® diluted to 0.1 ml

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Kaohsiung Medical University Hospital

Kaohsiung City, Taiwan

RECRUITING

Outcomes

Primary Outcomes

Scar pain relief

assessed by score 0,1,2 (0: no pain, 1: sometimes feel pain, 2: need medication)

Time frame: Change from baseline scar pain during 16 weeks after drug injection

scar appearance

assessed by vancouver scar scale(vascularity, pigmentation, pliability, height)

Time frame: 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)

Time frame: Change from baseline itch sensation during 16 weeks after drug injection

Central Contacts

Shu hung Huang, MD, PHD

CONTACT

886-3121101 huangsh63@gmail.com

Data from ClinicalTrials.gov

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