Keloid ScarsPhase 2NCT06814288
The Effectiveness of Intralesional Botulinum Toxin A and Triamcinolone Acetonide Injections in Keloid Treatment
A Phase 2 study testing Botulinum toxin A and Triamcinolone Acetonide in people with Keloid Scars, run by Universitas Padjadjaran at 1 site in Indonesia.
Trial summary
Keloids are benign fibrous tissue overgrowths that extend beyond the boundaries of the original wound and tend to recur after therapy. The exact pathogenesis of keloids is not fully understood; however, the role of TGF-β leads to an imbalance in collagen synthesis and degradation, while VEGF increases vascularity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keloid Scars
- What is being tested?
- Botulinum toxin A and Triamcinolone Acetonide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 May 2024to 1 Mar 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female and male patients aged ≥ 18 years.
- Patients clinically diagnosed with keloids.
- Patients with at least two keloid lesions located on different sides but in similar anatomical regions.
- Keloid lesion size is limited to ≤ 5 cm².
- All keloid patients who will not undergo other keloid treatments (surgical excision, chemotherapy injections, laser therapy, radiation therapy, cryotherapy, or pressure therapy) during the study and observation period.
- All keloid patients who have not undergone any keloid treatment in the past two months.
Who cannot join
- Pregnant and breastfeeding women.
- Patients currently using hormonal contraceptives.
- Patients undergoing long-term systemic corticosteroid therapy.
- History of hypersensitivity to botulinum toxin.
- Use of or exposure to aminoglycosides, lincosamides, polymyxins, quinine, magnesium sulfate, anticholinesterases, succinylcholine, or other serotypes of botulinum toxin.
- Presence of motor peripheral neuropathy (e.g., amyotrophic lateral sclerosis or motor neuropathy), neuromuscular junction disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome), diabetes mellitus, or uncontrolled cardiovascular disorders.
- Infection at the injection site.
Trial locations and contacts
1 site in 1 country.
About this study
Keloids are benign fibrous tissue overgrowths that extend beyond the boundaries of the original wound and tend to recur after therapy. The exact pathogenesis of keloids is not fully understood; however, the role of TGF-β leads to an imbalance in collagen synthesis and degradation, while VEGF increases vascularity. Enhanced vascularity contributes to increased fibroblast activity. Angiogenesis is heightened in wounds subjected to high tension. Active keloids are characterized by low vascular velocity, low elasticity, and varied echogenicity depending on the filling tissue, as observed on ultrasonographic examination. Intralesional TA injections at 40 mg/ml are an available option for keloids, but this therapy is associated with various side effects. Intralesional TB-A injections at 5 U/cm³ have been reported to demonstrate good efficacy, safety, tolerable side effects, and high patient satisfaction for keloid management. Therefore, it is necessary to conduct a study comparing the effectiveness of intralesional TB-A injections at 5 U/cm³ with intralesional TA injections at 40 mg/ml in keloid patients. Scar assessment can generally be conducted objectively using various tools or subjectively through different measurement scales. The Japan Scar Workshop (JSW) developed a measurement scale known as the JSW scar scale (JSS).
Read the detailed description
This study aims to evaluate the effectiveness of intralesional TB-A injections at 5 U/cm³ compared to intralesional TA injections at 40 mg/ml in keloid patients in Indonesia, assessed using the Japan Scar Scale (JSS) and measurements of lesion volume, vascularization degree, vascular velocity, elasticity, and echogenicity through high-resolution ultrasonography. Such research has not been conducted before.
The study design is an experimental single-blind randomized trial with a pretest-posttest design. Participants include keloid patients seeking treatment at the Tumor and Dermatologic Surgery Clinic, Department of Dermatology and Venereology, RSHS Bandung, who meet the inclusion and exclusion criteria. Lesions and treatments are randomized by the researchers, and the selected treatment is then administered to the keloid lesions. Observations are repeated to evaluate the effectiveness of the therapy using JSS and high-resolution ultrasonography.
During patient visits, the following procedures are conducted:
History Taking and Physical Examination Patients undergo anamnesis and a thorough physical examination.
Baseline Keloid Lesion Measurement Initial lesion measurements are performed using a caliper to establish baseline data before therapy.
Elasticity Measurement Baseline lesion elasticity is measured using the Cutometer MPA 580 at the midpoint of each lesion. Skin erythema is assessed using the CM-700d Spectrophotometer.
High-Resolution Ultrasonography Assessment
A radiology specialist performs the ultrasonography using a Phillips EPIQ Elite® high-resolution ultrasound device with a linear transducer at 22 MHz. The machine's automatic settings for observing superficial structures are applied uniformly across cases.
Patients are positioned upright or lying down, depending on lesion location. The transducer is placed perpendicularly to the keloid lesion in both transverse and longitudinal orientations without applying pressure.
Measurements include lesion volume, vascularization degree, vascular velocity, elasticity, and echogenicity type.
Documentation involves recording data and capturing images on the ultrasound machine.
Photographic Documentation Lesions are photographed from the top and side for documentation.
Randomization and Group Assignment
Lesions are randomly assigned to one of two therapy groups:
Group I: Intralesional Botulinum Toxin A injection at 5 U/cm³. Group II: Intralesional Triamcinolone Acetonide injection at 40 mg/ml. These detailed procedures ensure a comprehensive evaluation of the comparative efficacy of the two treatments in managing keloid lesions.
- Conditions
- Keloid Scars
- Being tested
- Botulinum toxin A, Triamcinolone Acetonide
- Keywords
- Keloid, Botulinum Toxin A, Triamcinolone Acetonide, Intralesional Injection
- 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 ADrug
Twenty keloid patients will be injected botulinum toxin A intralesional every 4 weeks.
Triamcinolone AcetonideDrug
Twenty keloid patients will be injected triamcinolone acetonide intralesional every 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Botulinum Toxin A | Experimental | Twenty keloid patients will be injected botulinum toxin A intralesional every 4 weeks. Receives: Drug: Botulinum toxin A |
| Triamcinolone Acetonide | Active comparator | Twenty keloid patients will be injected triamcinolone acetonide intralesional every 4 weeks. Receives: Drug: Triamcinolone Acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Japan Scar Workshop Scar Scale (JSS)
Evaluation for Groups I and II is conducted every four weeks, specifically in the 4th, 8th, and 12th weeks. At each visit, assessments of JSS for evaluation consists of six items: (1) Induration, (2) Elevation, (3) Redness of the scar, (4) Erythema around the scar, (5) Spontaneous and pressing pain, and (6) Itch. Each item has four intensity categories, namely, None, Weak, Mild, and Strong. These categories are weighted 0, 1, 2, and 3, respectively. There are sample images of each category in each item that helps the user judge the items. The minimum and maximum total points in the evaluation table are thus 0 and 18, respectively. When the symptoms improve, the total score decreases.
Measured: 12 weeks
Lesion volume by ultrasonography
Lesion volume in mililiters (ml) are measured by high-resolution ultrasonography on the initial visit (before therapy) and week-12 (after therapy)
Measured: 12 weeks
Elasticity
Elasticity ratio between keloid lesion and normal skin are measured by cutometer and high-resolution ultrasonography on the initial visit (before therapy) and week-12 (after therapy)
Measured: 12 weeks
Echogenicity on ultrasonography
Echogenicity of keloid lesion are measured by high-resolution ultrasonography on the initial visit (before therapy) and week-12 (after therapy)
Measured: 12 weeks
Degree of Vascularity on ultrasonography
Degree of Vascularity of keloid lesion are measured by high-resolution ultrasonography on the initial visit (before therapy) and week-12 (after therapy)
Measured: 12 weeks
Secondary outcomes (2)
Visual Analogue Scale (VAS) after every injection session
Evaluation for Groups I and II is conducted every four weeks, specifically in the 4th, 8th, and 12th weeks. At each visit, assessments of VAS for therapy evaluation
Measured: 12 weeks
Adverse Effects
Evaluation of any adverse effects for Groups I and II is conducted every four weeks, specifically in the 4th, 8th, and 12th weeks
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start1 May 2024
- Primary completion28 Feb 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Keloid ScarsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Padjadjaran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eva K sutedja, M.D., Principal investigator, Universitas Padjadjaran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06814288
- Sponsor's protocol ID
- DV-202501.01
- Status last verified
- Feb 2025
- First submitted
- 3 Feb 2025
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Intralesional Botulinum Toxin A and Triamcinolone Acetonide Injections in Keloid Treatment
- ClinicalTrials.gov ID
- NCT06814288
- Acronym / sponsor ID
- DV-202501.01
- Conditions
- Keloid Scars
- Keywords
- Keloid, Botulinum Toxin A, Triamcinolone Acetonide, Intralesional Injection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universitas PadjadjaranUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 7 Feb 2025 (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.
Keloids are benign fibrous tissue overgrowths that extend beyond the boundaries of the original wound and tend to recur after therapy. The exact pathogenesis of keloids is not fully understood; however, the role of TGF-β leads to an imbalance in collagen synthesis and degradation, while VEGF increases vascularity. Enhanced vascularity contributes to increased fibroblast activity. Angiogenesis is heightened in wounds subjected to high tension. Active keloids are characterized by low vascular velocity, low elasticity, and varied echogenicity depending on the filling tissue, as observed on ultrasonographic examination. Intralesional TA injections at 40 mg/ml are an available option for keloids, but this therapy is associated with various side effects. Intralesional TB-A injections at 5 U/cm³ have been reported to demonstrate good efficacy, safety, tolerable side effects, and high patient satisfaction for keloid management. Therefore, it is necessary to conduct a study comparing the effectiveness of intralesional TB-A injections at 5 U/cm³ with intralesional TA injections at 40 mg/ml in keloid patients. Scar assessment can generally be conducted objectively using various tools or subjectively through different measurement scales. The Japan Scar Workshop (JSW) developed a measurement scale known as the JSW scar scale (JSS).
Detailed description
This study aims to evaluate the effectiveness of intralesional TB-A injections at 5 U/cm³ compared to intralesional TA injections at 40 mg/ml in keloid patients in Indonesia, assessed using the Japan Scar Scale (JSS) and measurements of lesion volume, vascularization degree, vascular velocity, elasticity, and echogenicity through high-resolution ultrasonography. Such research has not been conducted before.
The study design is an experimental single-blind randomized trial with a pretest-posttest design. Participants include keloid patients seeking treatment at the Tumor and Dermatologic Surgery Clinic, Department of Dermatology and Venereology, RSHS Bandung, who meet the inclusion and exclusion criteria. Lesions and treatments are randomized by the researchers, and the selected treatment is then administered to the keloid lesions. Observations are repeated to evaluate the effectiveness of the therapy using JSS and high-resolution ultrasonography.
During patient visits, the following procedures are conducted:
History Taking and Physical Examination Patients undergo anamnesis and a thorough physical examination.
Baseline Keloid Lesion Measurement Initial lesion measurements are performed using a caliper to establish baseline data before therapy.
Elasticity Measurement Baseline lesion elasticity is measured using the Cutometer MPA 580 at the midpoint of each lesion. Skin erythema is assessed using the CM-700d Spectrophotometer.
High-Resolution Ultrasonography Assessment
A radiology specialist performs the ultrasonography using a Phillips EPIQ Elite® high-resolution ultrasound device with a linear transducer at 22 MHz. The machine's automatic settings for observing superficial structures are applied uniformly across cases.
Patients are positioned upright or lying down, depending on lesion location. The transducer is placed perpendicularly to the keloid lesion in both transverse and longitudinal orientations without applying pressure.
Measurements include lesion volume, vascularization degree, vascular velocity, elasticity, and echogenicity type.
Documentation involves recording data and capturing images on the ultrasound machine.
Photographic Documentation Lesions are photographed from the top and side for documentation.
Randomization and Group Assignment
Lesions are randomly assigned to one of two therapy groups:
Group I: Intralesional Botulinum Toxin A injection at 5 U/cm³. Group II: Intralesional Triamcinolone Acetonide injection at 40 mg/ml. These detailed procedures ensure a comprehensive evaluation of the comparative efficacy of the two treatments in managing keloid lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botulinum Toxin A | Experimental | Drug: Botulinum toxin ATwenty keloid patients will be injected botulinum toxin A intralesional every 4 weeks. |
| Triamcinolone Acetonide | Active comparator | Drug: Triamcinolone AcetonideTwenty keloid patients will be injected triamcinolone acetonide intralesional every 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female and male patients aged ≥ 18 years.
- Patients clinically diagnosed with keloids.
- Patients with at least two keloid lesions located on different sides but in similar anatomical regions.
- Keloid lesion size is limited to ≤ 5 cm².
- All keloid patients who will not undergo other keloid treatments (surgical excision, chemotherapy injections, laser therapy, radiation therapy, cryotherapy, or pressure therapy) during the study and observation period.
Key exclusion criteria (7 listed)
- Pregnant and breastfeeding women.
- Patients currently using hormonal contraceptives.
- Patients undergoing long-term systemic corticosteroid therapy.
- History of hypersensitivity to botulinum toxin.
- Use of or exposure to aminoglycosides, lincosamides, polymyxins, quinine, magnesium sulfate, anticholinesterases, succinylcholine, or other serotypes of botulinum toxin.
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 ATwenty keloid patients will be injected botulinum toxin A intralesional every 4 weeks. | Drug | Botulinum Toxin A |
| Triamcinolone AcetonideTwenty keloid patients will be injected triamcinolone acetonide intralesional every 4 weeks. | Drug | Triamcinolone Acetonide |
Primary outcome
Japan Scar Workshop Scar Scale (JSS)
Time frame: 12 weeks
Evaluation for Groups I and II is conducted every four weeks, specifically in the 4th, 8th, and 12th weeks. At each visit, assessments of JSS for evaluation consists of six items: (1) Induration, (2) Elevation, (3) Redness of the scar, (4) Erythema around the scar, (5) Spontaneous and pressing pain, and (6) Itch. Each item has four intensity categories, namely, None, Weak, Mild, and Strong. These categories are weighted 0, 1, 2, and 3, respectively. There are sample images of each category in each item that helps the user judge the items. The minimum and maximum total points in the evaluation table are thus 0 and 18, respectively. When the symptoms improve, the total score decreases.
Lesion volume by ultrasonography
Time frame: 12 weeks
Lesion volume in mililiters (ml) are measured by high-resolution ultrasonography on the initial visit (before therapy) and week-12 (after therapy)
Elasticity
Time frame: 12 weeks
Elasticity ratio between keloid lesion and normal skin are measured by cutometer and high-resolution ultrasonography on the initial visit (before therapy) and week-12 (after therapy)
Echogenicity on ultrasonography
Time frame: 12 weeks
Echogenicity of keloid lesion are measured by high-resolution ultrasonography on the initial visit (before therapy) and week-12 (after therapy)
Degree of Vascularity on ultrasonography
Time frame: 12 weeks
Degree of Vascularity of keloid lesion are measured by high-resolution ultrasonography on the initial visit (before therapy) and week-12 (after therapy)
2 secondary outcomes
Visual Analogue Scale (VAS) after every injection session
Time frame: 12 weeks
Adverse Effects
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
Related trials for Keloid Scars
Not yet recruiting
Fractional Radiofrequency With Streroids Versus Fractional CO2 Laser With Steroids in the Treatment of Keloids
Keloids
Active, not recruiting
Transdermal Versus Intralesional Betamethasone for Keloids
Keloid
RecruitingPhase 2
Ritlecitinib in Patients With Keloids or Those Undergoing Keloidectomy
Keloid
Recruiting
Radiotherapy for Keloids
Keloid
Not yet recruitingPhase 2
siRNA Microneedle Patches for Ear Keloid Post-Surgical Scars
Keloid of Ear Lobe
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.
Eva K sutedja, M.D. principal investigator
Universitas Padjadjaran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Botulinum toxin A and Triamcinolone Acetonide in people with Keloid Scars, run by Universitas Padjadjaran at 1 site in Indonesia.
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 6 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 7 Feb 2025. 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 Indonesia. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Japan Scar Workshop Scar Scale (JSS) (time frame: 12 weeks). The study lists 5 primary outcomes in all. 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 Feb 2025.