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

Not Applicable

• Conditions: Hypertrophic Scar; Itchiness; Botulinum Toxin
• Interventions: Drug: Placebo; Drug: Botulinum Toxins

• Registration Number: NCT02168634
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2014-03-11
• Study First Submitted QC: 2014-06-18
• Study First Posted: 2014-06-20
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-07
• Last Update Posted: 2015-10-09
• Primary Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal Saline	Placebo	1cc normal saline, administered in the other itchy point
Botulinum toxin	Botulinum Toxins	5U Botulinum toxin in 1cc normal saline, administered in one of the two itchy points

Primary Outcome Measures

Name	Time	Method
The degree of itchiness	6 months

Secondary Outcome Measures

Name	Time	Method
Pain scale	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.

Trial Locations

Locations (1)

Kaohsiung Veterans General Hospital; 🇨🇳 Kaohsiung, Taiwan