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

NCT ID: NCT02168634

Last Updated: 2015-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Itchiness Hypertrophic Scar Botulinum Toxin

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Botulinum toxin

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

Group Type EXPERIMENTAL

Botulinum Toxins

Intervention Type DRUG

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

Normal Saline

1cc normal saline, administered in the other itchy point

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1cc normal saline, local injection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Botulinum Toxins

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

Intervention Type DRUG

Placebo

1cc normal saline, local injection

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kaohsiung Veterans General Hospital.

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kuei-Chang Hsu

Attending Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kaohsiung Veterans General Hospital

Kaohsiung City, , Taiwan

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Kuei-Chang Hsu, MD

Role: CONTACT

886975581795

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 22795731 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19624547 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

VGHKS13-CT12-23

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Botulinum Toxin Type A for Neuroma Pain
NCT01374191 WITHDRAWN PHASE2