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The Use of Botulinum Toxin in the Treatment of Itching From Hypertrophic Scar -- A Randomised Controlled Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02168634
Recruitment Status : Unknown
Verified October 2015 by Kuei-Chang Hsu, Kaohsiung Veterans General Hospital..
Recruitment status was:  Recruiting
First Posted : June 20, 2014
Last Update Posted : October 9, 2015
Sponsor:
Information provided by (Responsible Party):
Kuei-Chang Hsu, Kaohsiung Veterans General Hospital.

Tracking Information
First Submitted Date  ICMJE March 11, 2014
First Posted Date  ICMJE June 20, 2014
Last Update Posted Date October 9, 2015
Study Start Date  ICMJE November 2013
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2014)
The degree of itchiness [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2014)
Pain scale [ Time Frame: Within one minue after drug injection ]
We'll ask the participant about the pain during injection. The question will be asked within one minute after drug injection.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Use of Botulinum Toxin in the Treatment of Itching From Hypertrophic Scar -- A Randomised Controlled Trial
Official Title  ICMJE The Use of Botulinum Toxin in the Treatment of Itching From Hypertrophic Scar -- A Randomised Controlled Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Itchiness
  • Hypertrophic Scar
  • Botulinum Toxin
Intervention  ICMJE
  • Drug: Botulinum Toxins
    5U botulinum toxin in 1c.c. normal saline, local injection
  • Drug: Placebo
    1cc normal saline, local injection
Study Arms  ICMJE
  • Experimental: Botulinum toxin
    5U Botulinum toxin in 1cc normal saline, administered in one of the two itchy points
    Intervention: Drug: Botulinum Toxins
  • Placebo Comparator: Normal Saline
    1cc normal saline, administered in the other itchy point
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 18, 2014)
60
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. The patients undergoing laparotomy and thoracotomy in Veterans General Hospital in Kaohsiung (VGHKS) during 2003/1/1~2012/12/31
  2. Hypertrophic scars containing more than two itchy sites with itchiness scale >3
  3. Good wound healing condition, no infection sign
  4. Age older than 20 year-old

Exclusion Criteria:

  1. Allergy to Botulinum toxin
  2. Inability to express self-willingness
  3. Pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02168634
Other Study ID Numbers  ICMJE VGHKS13-CT12-23
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kuei-Chang Hsu, Kaohsiung Veterans General Hospital.
Study Sponsor  ICMJE Kaohsiung Veterans General Hospital.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Kaohsiung Veterans General Hospital.
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP