Hypertrophic Scar, Scar Keloid
Conditions
Keywords
Botulinum toxin type A, Triamcinolone, scar pain, scar itch
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.
Interventions
DRUGTriamcinolone
Triamcinolone 4mg diluted to 0.1 ml
DRUGLidocaine
0.1ml 2% Xylocaine
DRUGBotulinum toxin A
4U Botox® diluted to 0.1 ml
Sponsors
Kaohsiung Medical University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Taiwan
Contacts
Primary ContactShu hung Huang, MD, PHD
Outcome results
None listed