Botulinum Toxins Intralesional Injection for Scar Pain

Hypertrophic Scar Clinical Trial

Official title:

Intralesional Injection of Steroids and/or Botulinum Toxin Type A in Hypertrophic Scars and Keloids for Pain Improvement

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03982862
• Other study ID #: KMUHIRB-F(II)-20180062
• Status: Recruiting
• Phase: Phase 4
• Start date: July 30, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: June 2019
• Source: Kaohsiung Medical University
• Contact: Shu hung Huang, MD, PHD
• Phone: 886-3121101
• Email: huangsh63[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. However, investigators need well controlled study to prove this finding and assess the improvement of scar appearance.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cicatrix
• Cicatrix, Hypertrophic
• Hypertrophic Scar
• Hypertrophy
• Keloid
• Scar Keloid

Intervention

Drug:
• Triamcinolone
Triamcinolone 4mg diluted to 0.1 ml
• Lidocaine
0.1ml 2% Xylocaine
• Botulinum toxin A
4U Botox® diluted to 0.1 ml

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	scar appearance	assessed by vancouver scar scale(vascularity, pigmentation, pliability, height)	Change from baseline scar appearance during 16 weeks after drug injection
Primary	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