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

NCT02168634 | Unknown

• 1 other identifier: VGHKS13-CT12-23
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Itchiness; Hypertrophic Scar; Botulinum Toxin

Outcome Measures

Primary Outcomes (1)

• The degree of itchiness

  6 months

Secondary Outcomes (1)

• Pain scale

  Within one minue after drug injection

Study Arms (2)

Botulinum toxin

EXPERIMENTAL

5U Botulinum toxin in 1cc normal saline, administered in one of the two itchy points

Drug: Botulinum Toxins

Normal Saline

PLACEBO COMPARATOR

1cc normal saline, administered in the other itchy point

Drug: Placebo

Interventions

Botulinum Toxins DRUG

5U botulinum toxin in 1c.c. normal saline, local injection

Botulinum toxin

Placebo DRUG

1cc normal saline, local injection

Normal Saline

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Allergy to Botulinum toxin
• Inability to express self-willingness
• Pregnancy

Sponsors & Collaborators

• Kaohsiung Veterans General Hospital.: lead

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

RECRUITING

Related Publications (2)

• 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.

  PMID: 22795731 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.

  PMID: 19624547 BACKGROUND

MeSH Terms

Conditions

Cicatrix, Hypertrophic

Interventions

Botulinum Toxins

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Central Study Contacts

Kuei-Chang Hsu, MD

CONTACT

886975581795; kchsu@vghks.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: March 11, 2014
• First Posted: June 20, 2014
• Study Start: November 1, 2013
• Primary Completion: December 1, 2015
• Last Updated: October 9, 2015

Record last verified: 2015-10

Locations

TW (1)