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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | Active Comparator | 0.9% Normal saline 0.1 ml +Triamcinolone 4mg diluted to 0.1 ml + 0.1ml 2% Xylocaine per 1cm2 scar volume |
|
| botox group | Experimental | 4U Botox® diluted to 0.1 ml + Triamcinolone 4mg diluted to 0.1 ml + 0.1ml 2% Xylocaine per 1 cm2 scar volume |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triamcinolone | Drug | Triamcinolone 4mg diluted to 0.1 ml |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shu hung Huang, MD, PHD | Contact | 886-3121101 | 6866 | huangsh63@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Shu Hung Huang, MD, PHD | Kaohsiung Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Medical University Hospital | Recruiting | Kaohsiung City | Taiwan |
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| ID | Term |
|---|---|
| D007627 | Keloid |
| D017439 | Cicatrix, Hypertrophic |
| ID | Term |
|---|---|
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002921 | Cicatrix |
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| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| D013256 | Steroids |
| D008012 | Lidocaine |
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Lidocaine | Drug | 0.1ml 2% Xylocaine |
|
|
| Botulinum toxin A | Drug | 4U Botox® diluted to 0.1 ml |
|
|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013259 |
| Steroids, Fluorinated |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |