Botulinum Toxin Type a Injection to Prevent Keloid Recurrence

NCT05072821 | Completed Phase 4

• 1 other identifier: MOHW109-TDU-B-211-114003
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Scar Keloid

Keywords

Keloid; Botulinum Toxin type A; Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Keloid recurrence

  The recurrence of keloid will be determined by clinical examination evaluated by a dermatologist.

  One year

Secondary Outcomes (4)

• Subjective symptoms

  3, 6, 9 and 12 months

• Objective symptoms

  3, 6, 9 and 12 months

• Vancouver Scar Scale

  6 and 12 months

• Scar firmness

  6 and 12 months

Study Arms (2)

Botulinum Toxin type A injection side

EXPERIMENTAL

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.

Drug: Botulinum Toxin Type A Injection [Botox]

0.9% saline injection side

PLACEBO COMPARATOR

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.

Drug: 0.9% Sodium Chloride Injection

Interventions

Botulinum Toxin Type A Injection [Botox] 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.

Botulinum Toxin type A injection side

0.9% Sodium Chloride Injection 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.

0.9% saline injection side

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead
• Tainan Hospital, Ministry of Health and Welfare: collaborator

Study Sites (1)

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

Tainan, Taiwan, Taiwan

Location

MeSH Terms

Conditions

Keloid

Interventions

Botulinum Toxins, Type A; Sodium Chloride

Condition Hierarchy (Ancestors)

Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Yuan-Yu Hsueh, MD PhD

  National Cheng-Kung University and Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2021
• First Posted: October 11, 2021
• Study Start: October 13, 2020
• Primary Completion: March 20, 2024
• Study Completion: March 20, 2024
• Last Updated: November 7, 2024

Record last verified: 2024-10

Locations

TW (1)