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Botulinum Toxins Intralesional Injection for Scar Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03982862
Recruitment Status : Recruiting
First Posted : June 12, 2019
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
Sheng-Hua Wu, Kaohsiung Medical University

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox Scars

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




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)



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03982862


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

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Responsible Party: Sheng-Hua Wu, Attending Physician, anesthesiology, Kaohsiung Medical University
ClinicalTrials.gov Identifier: NCT03982862    
Other Study ID Numbers: KMUHIRB-F(II)-20180062
First Posted: June 12, 2019    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019

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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
Keywords provided by Sheng-Hua Wu, Kaohsiung Medical University:
Botulinum toxin type A
Triamcinolone
scar pain
scar itch
Additional relevant MeSH terms:
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Keloid
Cicatrix
Hypertrophy
Cicatrix, Hypertrophic
Fibrosis
Pathologic Processes
Pathological Conditions, Anatomical
Collagen Diseases
Connective Tissue Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Lidocaine
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Triamcinolone diacetate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Acetylcholine Release Inhibitors
Cholinergic Agents