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

Kaohsiung Veterans General Hospital

Status: Unknown

Conditions: Itchiness; Botulinum Toxin; Hypertrophic Scar

Treatments: Drug: Placebo; Drug: Botulinum Toxins

Study type: Interventional

Funder types: Other

Identifiers

NCT02168634

VGHKS13-CT12-23

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Botulinum toxin

Experimental group

Description:

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

Treatment:

Drug: Botulinum Toxins

Normal Saline

Placebo Comparator group

Description:

1cc normal saline, administered in the other itchy point

Treatment:

Drug: Placebo