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