Back to resultsThe Use of Botulinum Toxin in the Treatment of Itching From Hypertrophic Scar -- A Randomised Controlled Trial
Primary Purpose
Itchiness, Hypertrophic Scar, Botulinum Toxin
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Botulinum Toxins
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Itchiness
Eligibility Criteria
Inclusion Criteria:
- The patients undergoing laparotomy and thoracotomy in Veterans General Hospital in Kaohsiung (VGHKS) during 2003/1/1~2012/12/31
- Hypertrophic scars containing more than two itchy sites with itchiness scale >3
- Good wound healing condition, no infection sign
- Age older than 20 year-old
Exclusion Criteria:
- Allergy to Botulinum toxin
- Inability to express self-willingness
- Pregnancy
Sites / Locations
- Kaohsiung Veterans General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Botulinum toxin
Normal Saline
Arm Description
5U Botulinum toxin in 1cc normal saline, administered in one of the two itchy points
1cc normal saline, administered in the other itchy point
Outcomes
Primary Outcome Measures
The degree of itchiness
Secondary Outcome Measures
Pain scale
We'll ask the participant about the pain during injection. The question will be asked within one minute after drug injection.
Full Information
NCT ID
NCT02168634
First Posted
March 11, 2014
Last Updated
October 7, 2015
Sponsor
Kaohsiung Veterans General Hospital.
1. Study Identification
Unique Protocol Identification Number
NCT02168634
Brief Title
The Use of Botulinum Toxin in the Treatment of Itching From Hypertrophic Scar -- A Randomised Controlled Trial
Official Title
The Use of Botulinum Toxin in the Treatment of Itching From Hypertrophic Scar -- A Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaohsiung Veterans General Hospital.
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Itchiness, Hypertrophic Scar, Botulinum Toxin
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Botulinum toxin
Arm Type
Experimental
Arm Description
5U Botulinum toxin in 1cc normal saline, administered in one of the two itchy points
Arm Title
Normal Saline
Arm Type
Placebo Comparator
Arm Description
1cc normal saline, administered in the other itchy point
Intervention Type
Drug
Intervention Name(s)
Botulinum Toxins
Intervention Description
5U botulinum toxin in 1c.c. normal saline, local injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1cc normal saline, local injection
Primary Outcome Measure Information:
Title
The degree of itchiness
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Pain scale
Description
We'll ask the participant about the pain during injection. The question will be asked within one minute after drug injection.
Time Frame
Within one minue after drug injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patients undergoing laparotomy and thoracotomy in Veterans General Hospital in Kaohsiung (VGHKS) during 2003/1/1~2012/12/31
Hypertrophic scars containing more than two itchy sites with itchiness scale >3
Good wound healing condition, no infection sign
Age older than 20 year-old
Exclusion Criteria:
Allergy to Botulinum toxin
Inability to express self-willingness
Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kuei-Chang Hsu, MD
Phone
886975581795
Email
kchsu@vghks.gov.tw
Facility Information:
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kuei-Chang Hsu, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
22795731
Citation
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.
Results Reference
background
PubMed Identifier
19624547
Citation
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.
Results Reference
background
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The Use of Botulinum Toxin in the Treatment of Itching From Hypertrophic Scar -- A Randomised Controlled Trial
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