Botulinum Toxin and Mesotherapy on Enhancement of Facial Scarring

August 16, 2024 updated by: Hams Hamed Abdelrahman

Botulinum Toxin Versus Mesotherapy on Enhancement of Facial Scarring (A Randomized Controlled Clinical Trial)

Most of the body's tissues can undergo wound repair following a disruption of tissue integrity. Upon healing, these wounds result in scar formation. The scars widen when the overlying musculature pulls apart suture lines. Botulinum Toxin A (BTA) is known to prevent fibroblast proliferation and it also induces temporary muscle paralysis. Also, mesotherapy is the non-invasive transdermal injection which can aid the skin to increase collagen and elastin production. Thus, both techniques are eligible for enhancement of facial scars.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient suffering from vertical or oblique forehead lacerations caused by trauma.
  • Recent and fresh wounds.
  • Atrophic scar (linear scar).

Exclusion Criteria:

  • Infected wound.
  • Patient on chemotherapy treatment and history of malignancy.
  • Patients suffering from burns on the forehead or complicated lacerations.
  • Allergy to drugs used in this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: BTA injection
Other: Botulinum Toxin Type A
Patients will receive BTA injection within a period of 5 days after primary closure.
Experimental: Mesotherapy
Other: Mesotherapy
Patients will receive mesotherapy growth factor serum with a derma pen within a period of 5 days after primary closure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in scar appearance
Time Frame: Baseline, 1 month, 3 months, 6 months

The Vancouver Scar Scale (VSS) will be measured to calculate scar appearance. The VSS evaluates four indicators: vascularity, pigmentation, pliability, and height. It has a score ranging from 0-13.

  • Vascularity: Normal 0, Pink 1, Red 2, Purple 3
  • Pigmentation: Normal 0, Hypopigmentation 1, Hyperpigmentation 2
  • Pliability: Normal 0, Supple 1, Yielding 2, Firm 3, Ropes 4, Contracture 5
  • Height: Flat (0), < 2 mm (1), 2-5 mm (2), > 5 mm (3)
Baseline, 1 month, 3 months, 6 months
Change in wound width
Time Frame: Baseline, 1 month, 3 months, 6 months
The mean wound width will be measured using a graduated Vernier caliper
Baseline, 1 month, 3 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hams Hamed Abdelrahman

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2022

Primary Completion (Actual)

July 20, 2024

Study Completion (Actual)

July 20, 2024

Study Registration Dates

First Submitted

August 16, 2024

First Submitted That Met QC Criteria

August 16, 2024

First Posted (Actual)

August 20, 2024

Study Record Updates

Last Update Posted (Actual)

August 20, 2024

Last Update Submitted That Met QC Criteria

August 16, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0926-5/2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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