Scar KeloidPhase 4NCT05072821
Botulinum Toxin Type a Injection to Prevent Keloid Recurrence
A Phase 4 study testing Botulinum Toxin Type A Injection [Botox] and 0.9% Sodium Chloride Injection in people with Scar Keloid, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Scar Keloid
- What is being tested?
- Botulinum Toxin Type A Injection [Botox] and 0.9% Sodium Chloride Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 Oct 2020to 20 Mar 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University
Tainan, Taiwan
About this study
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
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.
Read the 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
- Being tested
- Botulinum Toxin Type A Injection [Botox], 0.9% Sodium Chloride Injection
- Keywords
- Keloid, Botulinum Toxin type A, Radiotherapy
- Medical subject headings
- Keloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
0.9% Sodium Chloride InjectionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: 0.9% Sodium Chloride Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Keloid recurrence
The recurrence of keloid will be determined by clinical examination evaluated by a dermatologist.
Measured: One year
Secondary outcomes (4)
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.
Measured: 3, 6, 9 and 12 months
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.
Measured: 3, 6, 9 and 12 months
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.
Measured: 6 and 12 months
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.
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start13 Oct 2020
- Primary completion20 Mar 2024
- Study completion20 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scar KeloidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tainan Hospital, Ministry of Health and Welfare
- Responsible party
- Sponsor
- Investigators
- Yuan-Yu Hsueh, MD PhD, Principal investigator, National Cheng-Kung University and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05072821
- Sponsor's protocol ID
- MOHW109-TDU-B-211-114003
- Status last verified
- Oct 2024
- First submitted
- 30 Aug 2021
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05072821
- Acronym / sponsor ID
- MOHW109-TDU-B-211-114003
- Conditions
- Scar Keloid
- Keywords
- Keloid, Botulinum Toxin type A, Radiotherapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Collaborators
- Tainan Hospital, Ministry of Health and Welfare
- Study start
- 13 Oct 2020 (actual)
- Primary completion
- 20 Mar 2024 (actual)
- Study completion
- 20 Mar 2024 (actual)
- First posted
- 11 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botulinum Toxin type A injection side | Experimental | Drug: Botulinum Toxin Type A Injection [Botox]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. |
| 0.9% saline injection side | Placebo comparator | Drug: 0.9% Sodium Chloride InjectionThe 0.9% saline will be injected into the dermal layer before skin closure in keloid excision surgery. The dosage is 0.16 mL/cm. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Botulinum Toxin type A injection side |
| 0.9% Sodium Chloride InjectionAfter 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. | Drug | 0.9% saline injection side |
Primary outcome
Keloid recurrence
Time frame: One year
The recurrence of keloid will be determined by clinical examination evaluated by a dermatologist.
4 secondary outcomes
Subjective symptoms
Time frame: 3, 6, 9 and 12 months
Objective symptoms
Time frame: 3, 6, 9 and 12 months
Vancouver Scar Scale
Time frame: 6 and 12 months
Scar firmness
Time frame: 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuan-Yu Hsueh, MD PhD principal investigator
National Cheng-Kung University and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Botulinum Toxin Type A Injection [Botox] and 0.9% Sodium Chloride Injection in people with Scar Keloid, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Keloid recurrence (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.