Clinical trial

Immediate Injection of Botulinum Toxin Type A After Keloid Scar Revision to Prevent Keloid Recurrence: a Prospective, Split-scar, Double-blind, Randomized Controlled Study

Name

MOHW109-TDU-B-211-114003

Description

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.

Trial arms

Trial start

2020-10-13

Estimated PCD

2024-03-20

Trial end

2024-03-20

Status

Active (not recruiting)

Phase

Early phase I

Treatment

Botulinum Toxin Type A Injection [Botox]

After the whole surgical procedures of keloid revision are done, the participants will receive Botulinum Toxin type A (BTA) injection. The investigators split the scar into the right side and the left side. BTA and 0.9% saline, respectively, are used for the two arms of the study. Vials containing 100 units of BTA (BotoxⓇ, Allergan) are mixed with 2mL 0.9% injectable saline. The injection depth will be the intradermal layer. Injections will be performed with a 30-gauge needle and 1 mL syringe. Just before skin closure, the entire scar was treated, with sides randomized to receive treatment with either BTA or 0.9% normal saline. The dosage is 8 units / cm based on aforementioned studies. The maximal dose won't exceed 100 units.

Arms:

Botulinum Toxin type A injection side

0.9% Sodium Chloride Injection

After the whole surgical procedures of keloid revision are done, the participants will receive 0.9% saline injection. The investigators split the scar into the right side and the left side. BTA and 0.9% saline, respectively, are used for the two arms of the study. Only 0.9% saline is injected on the control side. The injection depth will be the intradermal layer. Injections will be performed with a 30-gauge needle and 1 mL syringe. Just before skin closure, the entire scar was injected, with sides randomized to receive treatment with either BTA or 0.9% normal saline. The dosage is 0.16 mL / cm.

Arms:

0.9% saline injection side

Size

Primary endpoint

Keloid recurrence

One year

Eligibility 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 28, 'type': 'ACTUAL'}}

Updated at

2023-11-18

1 organization

Organization

National Cheng-Kung University Hospital