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

Hypertrophic Scar Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02168634
• Other study ID #: VGHKS13-CT12-23
• Status: Recruiting
• Phase: N/A
• First received: March 11, 2014
• Last updated: October 7, 2015
• Start date: November 2013

Study information

• Verified date: October 2015
• Source: Kaohsiung Veterans General Hospital.
• Contact: Kuei-Chang Hsu, MD
• Phone: 886975581795
• Email: kchsu[@]vghks.gov.tw
• Is FDA regulated: No
• Health authority: Taiwan : Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Botulinum Toxin
• Cicatrix, Hypertrophic
• Hypertrophic Scar
• Hypertrophy
• Itchiness

Intervention

Drug:
• Botulinum Toxins
5U botulinum toxin in 1c.c. normal saline, local injection
• Placebo
1cc normal saline, local injection

Locations

Country	Name	City	State
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Veterans General Hospital.

Country where clinical trial is conducted

Taiwan, 

References & 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The degree of itchiness		6 months	No
Secondary	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	No