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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.

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.

Condition or disease Intervention/treatment Phase
Itchiness Hypertrophic Scar Botulinum Toxin Drug: Botulinum Toxins Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Use of Botulinum Toxin in the Treatment of Itching From Hypertrophic Scar -- A Randomised Controlled Trial
Study Start Date : November 2013
Estimated Primary Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Itching Scars

Arm Intervention/treatment
Experimental: Botulinum toxin
5U Botulinum toxin in 1cc normal saline, administered in one of the two itchy points
Drug: Botulinum Toxins
5U botulinum toxin in 1c.c. normal saline, local injection

Placebo Comparator: Normal Saline
1cc normal saline, administered in the other itchy point
Drug: Placebo
1cc normal saline, local injection




Primary Outcome Measures :
  1. The degree of itchiness [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02168634


Contacts
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Contact: Kuei-Chang Hsu, MD 886975581795 kchsu@vghks.gov.tw

Locations
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Taiwan
Kaohsiung Veterans General Hospital Recruiting
Kaohsiung, Taiwan
Principal Investigator: Kuei-Chang Hsu, MD         
Sponsors and Collaborators
Kaohsiung Veterans General Hospital.
Publications:
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Responsible Party: Kuei-Chang Hsu, Attending Physician, Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier: NCT02168634    
Other Study ID Numbers: VGHKS13-CT12-23
First Posted: June 20, 2014    Key Record Dates
Last Update Posted: October 9, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Hypertrophy
Cicatrix, Hypertrophic
Cicatrix
Fibrosis
Pathologic Processes
Pathological Conditions, Anatomical
Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs