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Botulinum Toxins Intralesional Injection for Scar Pain

Primary Purpose

Scar Keloid, Hypertrophic Scar

Status

Unknown status

Phase

Phase 4

Locations

Taiwan

Study Type

Interventional

Intervention

Triamcinolone

Lidocaine

Botulinum toxin A

About this trial

This is an interventional treatment trial for Scar Keloid focused on measuring Botulinum toxin type A, Triamcinolone, scar pain, scar itch

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Kaohsiung Medical University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

control group

botox group

Arm Description

0.9% Normal saline 0.1 ml +Triamcinolone 4mg diluted to 0.1 ml + 0.1ml 2% Xylocaine per 1cm2 scar volume

4U Botox® diluted to 0.1 ml + Triamcinolone 4mg diluted to 0.1 ml + 0.1ml 2% Xylocaine per 1 cm2 scar volume

Outcomes

Primary Outcome Measures

Scar pain relief

assessed by score 0,1,2 (0: no pain, 1: sometimes feel pain, 2: need medication)

scar appearance

assessed by vancouver scar scale(vascularity, pigmentation, pliability, height)

itch

assessed by score 0,1,2 (0: no itch, 1: sometimes feel itch, 2: need medication)

Secondary Outcome Measures

Full Information

NCT ID

NCT03982862

First Posted

June 9, 2019

Last Updated

June 13, 2019

Sponsor

Kaohsiung Medical University

1. Study Identification

Unique Protocol Identification Number

NCT03982862

Brief Title

Botulinum Toxins Intralesional Injection for Scar Pain

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Unknown status

Study Start Date

July 30, 2018 (Actual)

Primary Completion Date

June 30, 2019 (Anticipated)

Study Completion Date

June 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kaohsiung Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Scar Keloid, Hypertrophic Scar

Keywords

Botulinum toxin type A, Triamcinolone, scar pain, scar itch

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

control group

Arm Type

Active Comparator

Arm Description

0.9% Normal saline 0.1 ml +Triamcinolone 4mg diluted to 0.1 ml + 0.1ml 2% Xylocaine per 1cm2 scar volume

Arm Title

botox group

Arm Type

Experimental

Arm Description

4U Botox® diluted to 0.1 ml + Triamcinolone 4mg diluted to 0.1 ml + 0.1ml 2% Xylocaine per 1 cm2 scar volume

Intervention Type

Drug

Intervention Name(s)

Triamcinolone

Other Intervention Name(s)

steroid

Intervention Description

Triamcinolone 4mg diluted to 0.1 ml

Intervention Type

Drug

Intervention Name(s)

Lidocaine

Other Intervention Name(s)

Xylocaine

Intervention Description

0.1ml 2% Xylocaine

Intervention Type

Drug

Intervention Name(s)

Botulinum toxin A

Other Intervention Name(s)

botox

Intervention Description

4U Botox® diluted to 0.1 ml

Primary Outcome Measure Information:

Title

Scar pain relief

Description

assessed by score 0,1,2 (0: no pain, 1: sometimes feel pain, 2: need medication)

Time Frame

Change from baseline scar pain during 16 weeks after drug injection

Title

scar appearance

Description

assessed by vancouver scar scale(vascularity, pigmentation, pliability, height)

Time Frame

Change from baseline scar appearance during 16 weeks after drug injection

Title

itch

Description

assessed by score 0,1,2 (0: no itch, 1: sometimes feel itch, 2: need medication)

Time Frame

Change from baseline itch sensation during 16 weeks after drug injection

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients have visible hypertrophic scars or keloids over three months after trauma or surgery. Patients have symptoms of pain, itching or erythema. Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shu hung Huang, MD, PHD

Phone

886-3121101

Ext

6866

huangsh63@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shu Hung Huang, MD, PHD

Organizational Affiliation

Kaohsiung Medical University

Official's Role

Study Director

Facility Information:

Facility Name

Kaohsiung Medical University Hospital

City

Kaohsiung

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shu Hung Huang, MD, PHD

Phone

886-3121101

Ext

6866

huangsh63@gmail.com

12. IPD Sharing Statement

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Botulinum Toxins Intralesional Injection for Scar Pain

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