Botulinum Toxin and Mesotherapy on Enhancement of Facial Scarring

NCT06562023 | Completed

• 1 other identifier: 0926-5/2024
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Facial Scars

Outcome Measures

Primary Outcomes (2)

• Change in scar appearance

  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

  The mean wound width will be measured using a graduated Vernier caliper

  Baseline, 1 month, 3 months, 6 months

Study Arms (3)

BTA injection

EXPERIMENTAL

Other: Botulinum Toxin Type A

Mesotherapy

EXPERIMENTAL

Other: Mesotherapy

Control

NO INTERVENTION

Interventions

Botulinum Toxin Type A OTHER

Patients will receive BTA injection within a period of 5 days after primary closure.

BTA injection

Mesotherapy OTHER

Patients will receive mesotherapy growth factor serum with a derma pen within a period of 5 days after primary closure.

Mesotherapy

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hams Hamed Abdelrahman: lead

Study Sites (1)

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

Alexandria, Egypt

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A; Mesotherapy

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Complementary Therapies; Therapeutics; Cosmetic Techniques; Injections, Subcutaneous; Injections; Drug Administration Routes; Drug Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Lecturer of Dental Public Health and biostatistical consultanat

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: August 20, 2024
• Study Start: November 19, 2022
• Primary Completion: July 20, 2024
• Study Completion: July 20, 2024
• Last Updated: August 20, 2024

Record last verified: 2024-08

Locations

EG (1)