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Hypertrophic ScarringPhase 2/3NCT04756882

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

A Phase 2/3 study testing AbobotulinumtoxinA 500 UNT in people with Hypertrophic Scarring, run by Alexandria University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Hypertrophic Scarring
What is being tested?
AbobotulinumtoxinA 500 UNT
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteEgypt
Study dates
18 Nov 2020to 1 Sep 2021
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • • 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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

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

    Alexandria, Azarita, 21500

Other trials in Egypt

About this study

Official title: Clinical Evaluation of the Efficacy OF Botulinum Toxin A for Improving Facial Scars (Randomized Clinical Trial )

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.

Read more

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

Read the detailed description
  1. All procedures were performed under local anesthesia in Oral and Maxillofacial Surgery Department, Alexandria University.
  2. Using nonalcoholic solution after makeup removal, a single surgeon performed the procedures under complete aseptic technique (Lee, Min et al. 2018).
  3. All patients wore a disposable cap to contain hair.
  4. We examined before treatment: the facial anatomy, mimic muscular contraction, facial expression, and any pre-existing asymmetry(Wilson 2006).
  5. Immediately after taking the photographs, both the length and width of the forehead wound were measured directly on the patients using a digital vernier caliper by a single plastic surgeon blinded to the study condition.
  6. Pain at the injected sites was minimized before each injection by applying topical anesthetics and cold iced devices.
  7. Micro fine 1.0 ml insulin syringes with a 29-G or 30-G needle were used.
  8. The dosages of the preparations are related to biological activity and are given in biological units (U). The units are termed according to the manufacturer as Speywood U (SU) for Dysport
  9. The drugs used were AboBotulinumToxin A Dysport (500 Speywood U) is to be reconstituted with 2.0 mL of sodium chloride 9 mg/mL (0.9%) injection solution. This results in a clear solution containing the 500 Speywood units of the active ingredient in a concentration of 250 units per 1.0 mL of the reconstituted solution. The reconstitution is to be performed in accordance with the rules of good clinical practice, particularly with respect to asepsis and within 15 day of reconstitutin.(Hexsel, Rutowitsch et al. 2009, Scaglione 2016, Lee, Min et al. 2018).
  10. The total dose is approximately 105 SU.
  11. The total dose is divieded into 75 SU injected by a (1-ml, , 30-gauge needle) insulin syringe along the scar length at the rate of approximately 12.5 SU (0.15 ml) per cm of wound length, in a linear pattern on either side of the wound. , with the needle prick positined approximately 5 mm from the edge of the wound, The injection was repeated every cm throughout the entire wound length and 30 SU are injected into frontalis muscle.(Wilson 2006, Hu, Zou et al. 2018, Kim, Lee et al. 2019)
  12. Injections were determined by a skin marker and done under the supervision of a qualified licensed supervisor.
  13. due to muscles contraction The injections were carried out on skin folds and are performed at different levels (intramuscular, subcutaneous, or intradermal) in more points for each region. The injections were administrated directly into the point of intense muscular contraction. On the other hand, where the contraction was weak, the injection was done at a deep or superficial intradermal level. Depth depends also on the effect we want to achieve: an extreme effect for intramuscular, a soft effect for subcutaneous or intradermal.(Iozzo, Tengattini et al. 2014)
  14. To prevent eyebrow ptosis, the drugs were not injected around the supraorbital rim.(Kim, Lee et al. 2019).
Being tested
AbobotulinumtoxinA 500 UNT
Keywords
Botulinum Toxin Type A, facial scarring, wound healing
Medical subject headings
Cicatrix, Hypertrophic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AbobotulinumtoxinA 500 UNTDrug

    Also called Dysport

    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

Study groups in NCT04756882
Study groupRoleWhat they receive
study groupExperimental6 patients received 12.5 speywood unit/cm (SU/cm) Dysport intramuscular \& intradermal injections, within the first 5 postoperative days of the trauma
Receives: Drug: AbobotulinumtoxinA 500 UNT
control groupNo interventionof 6 patients that acted as the control group and received no treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: baseline, 1st, 3rd, 6th months

  2. 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

    Measured: baseline, 1st, 3rd, 6th months

Secondary outcomes (1)

  1. color differences

    Quantified color differences between the scar and surrounding normal skin were measured and compared using the Commission International d'Eclairage (CIE) L*a*b* color coordinates for each patient. L*a*b* values of the region of interest were obtained using Adobe Photoshop 7.0 (Adobe Systems Incorporated, San Jose, CA.)

    Measured: baseline, 1st, 3rd, 6th months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Feb 2021
  2. Study start18 Nov 2020
  3. Primary completion18 May 2021 (estimated)
  4. Study completion1 Sep 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04756882
Sponsor's protocol ID
Oshetta
Status last verified
Feb 2021
First submitted
7 Feb 2021
Last updated
16 Feb 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing AbobotulinumtoxinA 500 UNT in people with Hypertrophic Scarring, run by Alexandria University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change in wound width (time frame: baseline, 1st, 3rd, 6th months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04756882.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2021.

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