Scar KeloidPhase 4NCT03982862
Botulinum Toxins Intralesional Injection for Scar Pain
A Phase 4 study testing Triamcinolone, Lidocaine and Botulinum toxin A in people with Scar Keloid and Hypertrophic Scar, run by Kaohsiung Medical University at 1 site in Taiwan.
Trial summary
Botulinum toxins has been approved by the FDA to treat chronic migraine. Botox had been shown to inhibiting the release of inflammatory mediators and peripheral neurotransmitters from sensory nerve to treat neuropathic pain. In the clinical practice, botox indeed effect in scar pain. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Scar Keloid, Hypertrophic Scar
- What is being tested?
- Triamcinolone, Lidocaine and Botulinum toxin A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Jul 2018to 30 Jun 2019
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients have visible hypertrophic scars or keloids over three months after trauma or surgery.
- Patients have symptoms of pain, itching or erythema.
Who cannot join
- Patients had either Botulinum toxin type A or Triamcinolone intralesional before in the same scar
- The scar size is larger than 10 cm2
- Immunocompromised status
- Systemic infection status
- Allergic to Botulinum toxin type A or steroids
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Medical University Hospital
Kaohsiung City
Shu Hung Huang, MD, PHD, 886-3121101 ext. 6866, huangsh63@gmail.com
About this study
Official title: Intralesional Injection of Steroids and/or Botulinum Toxin Type A in Hypertrophic Scars and Keloids for Pain Improvement
Botulinum toxins has been approved by the FDA to treat chronic migraine. Botox had been shown to inhibiting the release of inflammatory mediators and peripheral neurotransmitters from sensory nerve to treat neuropathic pain. In the clinical practice, botox indeed effect in scar pain. However, investigators need well controlled study to prove this finding and assess the improvement of scar appearance.
Read the detailed description
After surgery or trauma, scar tissues would form during the healing process. However, hypertrophic scars and keloids might happen to some patients, both of which are often pruritic and erythematous. Besides, the markedly elevated tumor-like appearance usually brings much concern to patients. Moreover, significant pain or discomfort could happen to keloids. Various treatment strategies were mentioned but without a solid solution to all of the scars. Investigators hope to evaluate the differences of scar volume, appearance and symptoms (itching and pain) in participants receiving simultaneous intralesional injection of Botulinum toxin type A and/or steroids. Besides, side effects would also be recorded. Investigators hope to establish a more effective intralesional injection therapy for participatns suffering from hypertrophic scars and keloids.
- Conditions
- Scar Keloid, Hypertrophic Scar
- Being tested
- Triamcinolone, Lidocaine, Botulinum toxin A
- Keywords
- Botulinum toxin type A, Triamcinolone, scar pain, scar itch
- Medical subject headings
- Keloid, Cicatrix, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriamcinoloneDrug
Also called steroid
Triamcinolone 4mg diluted to 0.1 ml
LidocaineDrug
Also called Xylocaine
0.1ml 2% Xylocaine
Botulinum toxin ADrug
Also called botox
4U Botox® diluted to 0.1 ml
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | 0.9% Normal saline 0.1 ml +Triamcinolone 4mg diluted to 0.1 ml + 0.1ml 2% Xylocaine per 1cm2 scar volume Receives: Drug: Triamcinolone; Drug: Lidocaine |
| botox group | Experimental | 4U Botox® diluted to 0.1 ml + Triamcinolone 4mg diluted to 0.1 ml + 0.1ml 2% Xylocaine per 1 cm2 scar volume Receives: Drug: Triamcinolone; Drug: Lidocaine; Drug: Botulinum toxin A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scar pain relief
assessed by score 0,1,2 (0: no pain, 1: sometimes feel pain, 2: need medication)
Measured: Change from baseline scar pain during 16 weeks after drug injection
scar appearance
assessed by vancouver scar scale(vascularity, pigmentation, pliability, height)
Measured: Change from baseline scar appearance during 16 weeks after drug injection
itch
assessed by score 0,1,2 (0: no itch, 1: sometimes feel itch, 2: need medication)
Measured: Change from baseline itch sensation during 16 weeks after drug injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2019
- Study start30 Jul 2018
- Primary completion30 Jun 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheng-Hua Wu, Kaohsiung Medical University
- Investigators
- Shu Hung Huang, MD, PHD, Study director, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03982862
- Sponsor's protocol ID
- KMUHIRB-F(II)-20180062
- Status last verified
- Jun 2019
- First submitted
- 9 Jun 2019
- Last updated
- 17 Jun 2019
- 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 17 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intralesional Injection of Steroids and/or Botulinum Toxin Type A in Hypertrophic Scars and Keloids for Pain Improvement
- ClinicalTrials.gov ID
- NCT03982862
- Acronym / sponsor ID
- KMUHIRB-F(II)-20180062
- Conditions
- Scar Keloid, Hypertrophic Scar
- Keywords
- Botulinum toxin type A, Triamcinolone, scar pain, scar itch
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Kaohsiung Medical UniversityUniversity, hospital or other
- Study start
- 30 Jul 2018 (actual)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 12 Jun 2019 (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.
Botulinum toxins has been approved by the FDA to treat chronic migraine. Botox had been shown to inhibiting the release of inflammatory mediators and peripheral neurotransmitters from sensory nerve to treat neuropathic pain. In the clinical practice, botox indeed effect in scar pain. However, investigators need well controlled study to prove this finding and assess the improvement of scar appearance.
Detailed description
After surgery or trauma, scar tissues would form during the healing process. However, hypertrophic scars and keloids might happen to some patients, both of which are often pruritic and erythematous. Besides, the markedly elevated tumor-like appearance usually brings much concern to patients. Moreover, significant pain or discomfort could happen to keloids. Various treatment strategies were mentioned but without a solid solution to all of the scars. Investigators hope to evaluate the differences of scar volume, appearance and symptoms (itching and pain) in participants receiving simultaneous intralesional injection of Botulinum toxin type A and/or steroids. Besides, side effects would also be recorded. Investigators hope to establish a more effective intralesional injection therapy for participatns suffering from hypertrophic scars and keloids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Drug: Triamcinolone, Drug: Lidocaine0.9% Normal saline 0.1 ml +Triamcinolone 4mg diluted to 0.1 ml + 0.1ml 2% Xylocaine per 1cm2 scar volume |
| botox group | Experimental | Drug: Triamcinolone, Drug: Lidocaine, Drug: Botulinum toxin A4U Botox® diluted to 0.1 ml + Triamcinolone 4mg diluted to 0.1 ml + 0.1ml 2% Xylocaine per 1 cm2 scar volume |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients have visible hypertrophic scars or keloids over three months after trauma or surgery.
- Patients have symptoms of pain, itching or erythema.
Key exclusion criteria (5 listed)
- Patients had either Botulinum toxin type A or Triamcinolone intralesional before in the same scar
- The scar size is larger than 10 cm2
- Immunocompromised status
- Systemic infection status
- Allergic to Botulinum toxin type A or steroids
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 |
|---|---|---|
| TriamcinoloneAlso: steroidTriamcinolone 4mg diluted to 0.1 ml | Drug | botox group, control group |
| LidocaineAlso: Xylocaine0.1ml 2% Xylocaine | Drug | botox group, control group |
| Botulinum toxin AAlso: botox4U Botox® diluted to 0.1 ml | Drug | botox group |
Primary outcome
Scar pain relief
Time frame: Change from baseline scar pain during 16 weeks after drug injection
assessed by score 0,1,2 (0: no pain, 1: sometimes feel pain, 2: need medication)
scar appearance
Time frame: Change from baseline scar appearance during 16 weeks after drug injection
assessed by vancouver scar scale(vascularity, pigmentation, pliability, height)
itch
Time frame: Change from baseline itch sensation during 16 weeks after drug injection
assessed by score 0,1,2 (0: no itch, 1: sometimes feel itch, 2: need medication)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2019.
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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.
Shu Hung Huang, MD, PHD study director
Kaohsiung Medical University
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 Triamcinolone, Lidocaine and Botulinum toxin A in people with Scar Keloid and Hypertrophic Scar, run by Kaohsiung Medical University 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 2 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: status not confirmed, as of the sponsor's last update on 17 Jun 2019. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shu hung Huang, MD, PHD (886-3121101 ext. 6866, huangsh63@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scar pain relief (time frame: Change from baseline scar pain during 16 weeks after drug injection). The study lists 3 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 17 Jun 2019.