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出境医 / 临床实验 / Botulinum Toxins Intralesional Injection for Scar Pain

Botulinum Toxins Intralesional Injection for Scar Pain

Study Description
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.

Condition or disease Intervention/treatment Phase
Scar Keloid Hypertrophic Scar Drug: Triamcinolone Drug: Lidocaine Drug: Botulinum toxin A Phase 4

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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intralesional Injection of Steroids and/or Botulinum Toxin Type A in Hypertrophic Scars and Keloids for Pain Improvement
Actual Study Start Date : July 30, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019
Arms and Interventions
Arm Intervention/treatment
Active Comparator: control group
0.9% Normal saline 0.1 ml +Triamcinolone 4mg diluted to 0.1 ml + 0.1ml 2% Xylocaine per 1cm2 scar volume
 Drug: Triamcinolone
Triamcinolone 4mg diluted to 0.1 ml
Other Name: steroid

Drug: Lidocaine
0.1ml 2% Xylocaine
Other Name: Xylocaine
Experimental: botox group
4U Botox® diluted to 0.1 ml + Triamcinolone 4mg diluted to 0.1 ml + 0.1ml 2% Xylocaine per 1 cm2 scar volume
 Drug: Triamcinolone
Triamcinolone 4mg diluted to 0.1 ml
Other Name: steroid

Drug: Lidocaine
0.1ml 2% Xylocaine
Other Name: Xylocaine

Drug: Botulinum toxin A
4U Botox® diluted to 0.1 ml
Other Name: botox
Outcome Measures
Primary Outcome Measures :
  1. 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)

  2. scar appearance [ Time Frame: Change from baseline scar appearance during 16 weeks after drug injection ]
    assessed by vancouver scar scale(vascularity, pigmentation, pliability, height)

  3. 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients have visible hypertrophic scars or keloids over three months after trauma or surgery.
  2. Patients have symptoms of pain, itching or erythema.

Exclusion Criteria:

  1. Patients had either Botulinum toxin type A or Triamcinolone intralesional before in the same scar
  2. The scar size is larger than 10 cm2
  3. Immunocompromised status
  4. Systemic infection status
  5. Allergic to Botulinum toxin type A or steroids
Contacts and Locations

Contacts
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Contact: Shu hung Huang, MD, PHD 886-3121101 ext 6866 huangsh63@gmail.com

Locations
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Taiwan
Kaohsiung Medical University Hospital Recruiting
Kaohsiung, Taiwan
Contact: Shu Hung Huang, MD, PHD    886-3121101 ext 6866    huangsh63@gmail.com   
Sponsors and Collaborators
Kaohsiung Medical University
Investigators
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Study Director: Shu Hung Huang, MD, PHD Kaohsiung Medical University
Tracking Information
First Submitted Date  ICMJE June 9, 2019
First Posted Date  ICMJE June 12, 2019
Last Update Posted Date June 17, 2019
Actual Study Start Date  ICMJE July 30, 2018
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 13, 2019)
  • 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)
Original Primary Outcome Measures  ICMJE
 (submitted: June 11, 2019) 		Scar pain relief [ Time Frame: 4 weeks ]
reduction of scar pain intensity by questionnaire
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2019)
  • itching sensation improvement [ Time Frame: 8 weeks ]
    questionnaire evaluation
  • scar appearness [ Time Frame: 8 weeks ]
    color, size, pigementation, softness
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Botulinum Toxins Intralesional Injection for Scar Pain
Official Title  ICMJE Intralesional Injection of Steroids and/or Botulinum Toxin Type A in Hypertrophic Scars and Keloids for Pain Improvement
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Scar Keloid
  • Hypertrophic Scar
Intervention  ICMJE
  • Drug: Triamcinolone
    Triamcinolone 4mg diluted to 0.1 ml
    Other Name: steroid
  • Drug: Lidocaine
    0.1ml 2% Xylocaine
    Other Name: Xylocaine
  • Drug: Botulinum toxin A
    4U Botox® diluted to 0.1 ml
    Other Name: botox
Study Arms  ICMJE
  • Active Comparator: control group
    0.9% Normal saline 0.1 ml +Triamcinolone 4mg diluted to 0.1 ml + 0.1ml 2% Xylocaine per 1cm2 scar volume
    Interventions:
    • Drug: Triamcinolone
    • Drug: Lidocaine
  • Experimental: botox group
    4U Botox® diluted to 0.1 ml + Triamcinolone 4mg diluted to 0.1 ml + 0.1ml 2% Xylocaine per 1 cm2 scar volume
    Interventions:
    • Drug: Triamcinolone
    • Drug: Lidocaine
    • Drug: Botulinum toxin A
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 13, 2019) 		20
Original Estimated Enrollment  ICMJE
 (submitted: June 11, 2019) 		40
Estimated Study Completion Date  ICMJE June 30, 2019
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients have visible hypertrophic scars or keloids over three months after trauma or surgery.
  2. Patients have symptoms of pain, itching or erythema.

Exclusion Criteria:

  1. Patients had either Botulinum toxin type A or Triamcinolone intralesional before in the same scar
  2. The scar size is larger than 10 cm2
  3. Immunocompromised status
  4. Systemic infection status
  5. Allergic to Botulinum toxin type A or steroids
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03982862
Other Study ID Numbers  ICMJE KMUHIRB-F(II)-20180062
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sheng-Hua Wu, Kaohsiung Medical University
Study Sponsor  ICMJE Kaohsiung Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Shu Hung Huang, MD, PHD Kaohsiung Medical University
PRS Account Kaohsiung Medical University
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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