Botulinum Toxin Type A Injection to Prevent Keloid Recurrence
Primary Purpose
Scar Keloid
Status
Recruiting
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Botulinum Toxin Type A Injection [Botox]
0.9% Sodium Chloride Injection
Sponsored by
About this trial
This is an interventional prevention trial for Scar Keloid focused on measuring Keloid, Botulinum Toxin type A, Radiotherapy
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
Sites / Locations
- National Cheng Kung University Hospital, College of Medicine, National Cheng Kung UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Botulinum Toxin type A injection side
0.9% saline injection side
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Keloid recurrence
The recurrence of keloid will be determined by clinical examination evaluated by a dermatologist.
Secondary Outcome Measures
Subjective symptoms
The subjective symptoms will be measured by the Patient Scale of the Patient and Observer Scar Assessment Scale. The Patient Scale consists six items and scores from 1 to 10 for each items. The score of 1 means much alike the normal skin and the score of 10 means worst imaginable scar.
Objective symptoms
The subjective symptoms will be measured by the Observer Scale of the Patient and Observer Scar Assessment Scale. The Observer Scale consists six items and scores from 1 to 10 for each items. The score of 1 means much alike the normal skin and the score of 10 means worst imaginable scar.
Vancouver Scar Scale
One dermatologist will evaluate the scar with the Vancouver Scar Scale. The Vancouver Scar Scale consists 4 items. The minimum score is 0, which means the scar is much alike normal skin. The maximal score is 13, which means purple, hyperpigmentation, contracture and elevated scar.
Scar firmness
The scar firmness is determined by the Cutometer parameter R0. R0 is maximum amplitude of the curve (the total elongation). The larger R0 is, the softer the scar is.
Full Information
NCT ID
NCT05072821
First Posted
August 30, 2021
Last Updated
February 23, 2023
Sponsor
National Cheng-Kung University Hospital
Collaborators
Tainan Hospital, Ministry of Health and Welfare
1. Study Identification
Unique Protocol Identification Number
NCT05072821
Brief Title
Botulinum Toxin Type A Injection to Prevent Keloid Recurrence
Official Title
Immediate Injection of Botulinum Toxin Type A After Keloid Scar Revision to Prevent Keloid Recurrence: a Prospective, Split-scar, Double-blind, Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 13, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cheng-Kung University Hospital
Collaborators
Tainan Hospital, Ministry of Health and Welfare
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scar Keloid
Keywords
Keloid, Botulinum Toxin type A, Radiotherapy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Botulinum Toxin type A injection side
Arm Type
Experimental
Arm Description
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.
Arm Title
0.9% saline injection side
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Botulinum Toxin Type A Injection [Botox]
Intervention Description
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
Intervention Name(s)
0.9% Sodium Chloride Injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Keloid recurrence
Description
The recurrence of keloid will be determined by clinical examination evaluated by a dermatologist.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Subjective symptoms
Description
The subjective symptoms will be measured by the Patient Scale of the Patient and Observer Scar Assessment Scale. The Patient Scale consists six items and scores from 1 to 10 for each items. The score of 1 means much alike the normal skin and the score of 10 means worst imaginable scar.
Time Frame
3, 6, 9 and 12 months
Title
Objective symptoms
Description
The subjective symptoms will be measured by the Observer Scale of the Patient and Observer Scar Assessment Scale. The Observer Scale consists six items and scores from 1 to 10 for each items. The score of 1 means much alike the normal skin and the score of 10 means worst imaginable scar.
Time Frame
3, 6, 9 and 12 months
Title
Vancouver Scar Scale
Description
One dermatologist will evaluate the scar with the Vancouver Scar Scale. The Vancouver Scar Scale consists 4 items. The minimum score is 0, which means the scar is much alike normal skin. The maximal score is 13, which means purple, hyperpigmentation, contracture and elevated scar.
Time Frame
6 and 12 months
Title
Scar firmness
Description
The scar firmness is determined by the Cutometer parameter R0. R0 is maximum amplitude of the curve (the total elongation). The larger R0 is, the softer the scar is.
Time Frame
6 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuan-Yu Hsueh, MD PhD
Phone
886-6-2353535
Ext
4275
Email
yyhsueh@mail.ncku.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuan-Yu Hsueh, MD PhD
Organizational Affiliation
National Cheng-Kung University and Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University
City
Tainan
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuan-Yu Hsueh, MD PhD
Phone
886-6-2353535
Ext
4275
Email
yyhsueh@mail.ncku.edu.tw
12. IPD Sharing Statement
Learn more about this trial
Botulinum Toxin Type A Injection to Prevent Keloid Recurrence
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