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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02168634

Enrollment

Registered

2014-06-20

Start date

2013-11-30

Completion date

Unknown

Last updated

2015-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Botulinum Toxin, Hypertrophic Scar, Itchiness

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.

Interventions

DRUGBotulinum Toxins

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

DRUGPlacebo

1cc normal saline, local injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The degree of itchiness	6 months

Secondary

Measure	Time frame	Description
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.

Countries

Taiwan

Contacts

Primary ContactKuei-Chang Hsu, MD

kchsu@vghks.gov.tw886975581795

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026