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Clinical Evaluation of the Efficacy OF Botulinum Toxin A for Improving Facial Scars

NCT04756882 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-02-16

No results posted yet for this study

Summary

Background: Scars widen when the overlying musculature pulls apart suture lines. Because Botulinum Toxin A (BTA) is known to prevent fibroblast proliferation and it also induces temporary muscle paralysis, the purpose of this current study is to evaluate the beneficial effects of Botulinum toxin type A (BTA) on scar formation.

Aim of this study: The aim of this study is to evaluate the efficacy and safety of early postoperative Botulinum Toxin type A (BTA) injection on improving vertical or oblique facial surgical scars.

Materials and methods: Patients with vertical or oblique forehead lacerations, treated by primary closure, will be enrolled in this study and randomized into two groups: One group (n =6) will receive BTA injection within 5 days of primary closure and the other group (n = 6) will receive no further treatment. Vancouver scar scale (VSS) Scores and wound width will be determined at the 1, 3 and 6 months follow-up visits, along with clinical photographs.

Results: Data will be collected, tabulated and statically analyzed. Key words: Botulinum Toxin Type A; facial scarring; wound healing; scar maturation

Conditions

  • Hypertrophic Scarring

Interventions

DRUG

AbobotulinumtoxinA 500 UNT

Anaerobic fermentation of the bacterium Clostridium botulinum produces botulinum toxin. A range of different C. Botulinum strains have been recognized; eight immunologically different serotypes (type A-H) are created and consist of botulinum neurotoxin complexed with a number of related proteins. Neurotoxin type A preparations are the most widely used for therapeutic application. There are currently three leading botulinum neurotoxin type A (BoNT/A) products on the market in the Western Hemisphere: onabotulinumtoxinA (ONA; Botox/Vistabel, Allergan Inc., Irvine, CA, USA), abobotulinum toxin A (ABO; Dysport/Ipsen Limited, Slough Berkshire, UK), and incobotulinum toxin A (INCO; Xeomin/Bocouture, Merz Pharmaceuticals GmbH, Frankfurt, Germany). In nature, BoNT-A is synthesized as macromolecular protein complexes

Sponsors & Collaborators

  • Alexandria University

    lead OTHER

Principal Investigators

  • mahitab M soliman, phd · Alexandria University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-18
Primary Completion
2021-05-18
Completion
2021-09-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04756882 on ClinicalTrials.gov