Botulinum Toxin Type a Injection to Prevent Keloid Recurrence

NCT ID: NCT05072821

Last Updated: 2024-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-13
• Study Completion Date: 2024-03-20

Brief 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.

Detailed Description

Continuous variables will be reported as the mean ± standard deviation(SD). Each aspect of the VSS score, POSAS score, and the Cutometer parameters of each scar half between the BTA and control groups will be analyzed longitudinally using the paired t test. The interrater consistency will be evaluated using the Spearman rho. All analyses will be performed with IBM SPSS Version 23.0 (IBM Corp., Redmond, Wash.). A value of p < 0.05 is considered to indicate statistical significance.

The sample size was calculated based on the results of the investigators' aforementioned study published in 2019. Thirty patients underwent keloid revision and then received radiation therapy based on our treatment protocol. The postoperative Vancouver Scar Scale score was 4.15 ± 1.74. If treatment could improve VSS score by 1, which was considered clinically significant, approximately 26 patients would have been necessary to provide a result with a real significance (using the same SD and considering the standard α error of 0.05 and a power of 0.8). Assuming a 20% non-compliance rate for follow-up evaluation, the sample size was increased to 32 patients.

Conditions

Scar Keloid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Botulinum Toxin type A injection side

The Botulinum Toxin type A will be injected into the dermal layer before skin closure in keloid excision surgery. The concentration of Botulinum Toxin type A is 100 units in 2 mL and dosage is 8 units/cm. The maximal dose is 100 units for each participant.

Group Type: EXPERIMENTAL

Botulinum Toxin Type A Injection [Botox]

Intervention Type: DRUG

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.

0.9% saline injection side

The 0.9% saline will be injected into the dermal layer before skin closure in keloid excision surgery. The dosage is 0.16 mL/cm.

Group Type: PLACEBO_COMPARATOR

0.9% Sodium Chloride Injection

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tainan Hospital, Ministry of Health and Welfare

OTHER

Sponsor Role: collaborator

National Cheng-Kung University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yuan-Yu Hsueh, MD PhD

Role: PRINCIPAL_INVESTIGATOR

National Cheng-Kung University and Hospital

Locations

National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University

Tainan City, Taiwan, Taiwan

Countries

Taiwan

Other Identifiers

MOHW109-TDU-B-211-114003

Identifier Type: -

Identifier Source: org_study_id