Botulinum Toxins Intralesional Injection for Scar Pain
Intralesional Injection of Steroids and/or Botulinum Toxin Type A in Hypertrophic Scars and Keloids for Pain Improvement
1 other identifier
interventional
20
1 country
1
Brief 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. However, investigators need well controlled study to prove this finding and assess the improvement of scar appearance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jul 2018
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 30, 2018
CompletedFirst Submitted
Initial submission to the registry
June 9, 2019
CompletedFirst Posted
Study publicly available on registry
June 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2019
CompletedJune 17, 2019
June 1, 2019
11 months
June 9, 2019
June 13, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Scar pain relief
assessed by score 0,1,2 (0: no pain, 1: sometimes feel pain, 2: need medication)
Change from baseline scar pain during 16 weeks after drug injection
scar appearance
assessed by vancouver scar scale(vascularity, pigmentation, pliability, height)
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)
Change from baseline itch sensation during 16 weeks after drug injection
Study Arms (2)
control group
ACTIVE COMPARATOR0.9% Normal saline 0.1 ml +Triamcinolone 4mg diluted to 0.1 ml + 0.1ml 2% Xylocaine per 1cm2 scar volume
botox group
EXPERIMENTAL4U Botox® diluted to 0.1 ml + Triamcinolone 4mg diluted to 0.1 ml + 0.1ml 2% Xylocaine per 1 cm2 scar volume
Interventions
Eligibility Criteria
You may qualify if:
- Patients have visible hypertrophic scars or keloids over three months after trauma or surgery.
- Patients have symptoms of pain, itching or erythema.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kaohsiung Medical University Hospital
Kaohsiung City, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Shu Hung Huang, MD, PHD
Kaohsiung Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending Physician, anesthesiology
Study Record Dates
First Submitted
June 9, 2019
First Posted
June 12, 2019
Study Start
July 30, 2018
Primary Completion
June 30, 2019
Study Completion
June 30, 2019
Last Updated
June 17, 2019
Record last verified: 2019-06