Botulinum Toxin and Mesotherapy on Enhancement of Facial Scarring

Not Applicable

Completed

• Conditions: Facial Scars
• Interventions: Other: Mesotherapy; Other: Botulinum Toxin Type A

• Registration Number: NCT06562023
• Lead Sponsor: Hams Hamed Abdelrahman

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-19
• Primary Completion: 2024-07-20
• Study Completion: 2024-07-20
• Status Verified: 2024-08
• Study First Submitted: 2024-08-16
• Study First Submitted QC: 2024-08-16
• Last Update Submitted: 2024-08-16
• Study First Posted: 2024-08-20
• Last Update Posted: 2024-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mesotherapy	Mesotherapy	-
BTA injection	Botulinum Toxin Type A	-

Primary Outcome Measures

Name	Time	Method
Change in scar appearance	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)
Change in wound width	Baseline, 1 month, 3 months, 6 months	The mean wound width will be measured using a graduated Vernier caliper

Trial Locations

Locations (1)

Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt