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Hypertrophic scar, a disfiguring tissue reaction to trauma, occurred in around 20 % of the population. The patients with hypertrophic scar usually seek medical assistance not just for the annoying appearance but mostly due to the intractable itchiness. There have been a variety of effective methods to alter the appearance of the scar. However, the treatments for itching from hypertrophic scar are scarce. In 2009, P.Gazerani used Botox to treat histamine-induced itch with favorable results. In the clinical setting, however, the efficacy of Botox to treat itch from hypertrophic scar was yet to be proven. Therefore, the goal of this study is to conduct a randomized controlled trials about using Botox to treat itch from hypertrophic scar.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botulinum toxin | Experimental | 5U Botulinum toxin in 1cc normal saline, administered in one of the two itchy points |
|
| Normal Saline | Placebo Comparator | 1cc normal saline, administered in the other itchy point |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum Toxins | Drug | 5U botulinum toxin in 1c.c. normal saline, local injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The degree of itchiness | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pain scale | We'll ask the participant about the pain during injection. The question will be asked within one minute after drug injection. | Within one minue after drug injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kuei-Chang Hsu, MD | Contact | 886975581795 | kchsu@vghks.gov.tw |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Veterans General Hospital | Recruiting | Kaohsiung City | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22795731 | Background | Akhtar N, Brooks P. The use of botulinum toxin in the management of burns itching: preliminary results. Burns. 2012 Dec;38(8):1119-23. doi: 10.1016/j.burns.2012.05.014. Epub 2012 Jul 12. | |
| 19624547 | Background | Gazerani P, Pedersen NS, Drewes AM, Arendt-Nielsen L. Botulinum toxin type A reduces histamine-induced itch and vasomotor responses in human skin. Br J Dermatol. 2009 Oct;161(4):737-45. doi: 10.1111/j.1365-2133.2009.09305.x. Epub 2009 May 11. |
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| ID | Term |
|---|---|
| D017439 | Cicatrix, Hypertrophic |
| ID | Term |
|---|---|
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| ID | Term |
|---|---|
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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| Placebo |
| Drug |
1cc normal saline, local injection |
|
| 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 |