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

NCT04756882 | Unknown Phase 2 DMC

• 1 other identifier: Oshetta
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Botulinum Toxin Type A; facial scarring; wound healing

Outcome Measures

Primary Outcomes (2)

• change in wound width

  The mean width of the forehead wound of each group was measured be a digital vernier caliper for both the 1-month, 3-month and 6-month visits

  baseline, 1st, 3rd, 6th months

• change of vancouver scar scale

  The Vancouver scar scale (VSS) was assessed by two plastic surgeons in an independent, blinded fashion to quantify scar appearance at the 1-month, 3-month and 6-month visits

  baseline, 1st, 3rd, 6th months

Secondary Outcomes (1)

• color differences

  baseline, 1st, 3rd, 6th months

Study Arms (2)

study group

EXPERIMENTAL

6 patients received 12.5 speywood unit/cm (SU/cm) Dysport intramuscular \& intradermal injections, within the first 5 postoperative days of the trauma

Drug: AbobotulinumtoxinA 500 UNT

control group

NO INTERVENTION

of 6 patients that acted as the control group and received no treatment

Interventions

AbobotulinumtoxinA 500 UNT DRUG

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

Also known as: Dysport

study group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged from 18 to 40 years.
• Patients free from any systemic disease.
• Patients who understand verbal and written instructions

You may not qualify if:

• Patients with horizontal forehead lacerations.
• Patients suffering from complicated forehead lacerations that require grafting.
• Patients with forehead burns.
• Patients with neuromuscular disorders.
• Patients with previous surgical or non-surgical intervention.
• Patients allergic to drugs used in this study

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

oral & maxillofacial surgery department ,faculty of dentistry, Alexandria university

Alexandria, Azarita, 21500, Egypt

Location

MeSH Terms

Conditions

Cicatrix, Hypertrophic

Interventions

abobotulinumtoxinA

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• mahitab M soliman, phd

  Alexandria University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: researcher

Study Record Dates

• First Submitted: February 7, 2021
• First Posted: February 16, 2021
• Study Start: November 18, 2020
• Primary Completion: May 18, 2021
• Study Completion: September 1, 2021
• Last Updated: February 16, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)