Overview

Botulinum Toxin Type A Injection to Prevent Keloid Recurrence

Status:
Recruiting
Trial end date:
2023-12-01
Target enrollment:
0
Participant gender:
All
Summary
The prospective, split-scar, double-blind, randomized controlled study will enroll the patients who are older than 20 years with progressive keloid lesion which is symmetric. Botulinum toxin A will be injected into half of each keloid revision wound immediately after skin closure. The scars will be assessed at 1-year follow-up with Vancouver Scar Scale (VSS), Patient and Observer Scar Assessment Scale (POSAS), and the Cutometer.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
National Cheng-Kung University Hospital
Collaborator:
Tainan Hospital, Ministry of Health and Welfare
Treatments:
abobotulinumtoxinA
Botulinum Toxins
Botulinum Toxins, Type A
Criteria
Inclusion Criteria:

- Adult (20 years or older)

- Progressive keloid lesion that is bilaterally symmetric, mandibular area, anterior
chest or suprapubic area, for example

- At least 4 cm in length

- Repeated or uncontrolled recurrence, and unendurable symptoms with poor response to
conservative modalities

- Valid written informed consent provided for surgery and trial inclusion

Exclusion Criteria:

- Allergy to botulinum toxin

- Previous botulinum toxin injection at the lesion within 6 months before enrollment

- Myasthenia gravis

- Focal infection signs

- Pregnant or breastfeeding woman