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Botulinum Toxin and Mesotherapy on Enhancement of Facial Scarring

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06562023
Enrollment
33
Registered
2024-08-20
Start date
2022-11-19
Completion date
2024-07-20
Last updated
2024-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Facial Scars

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.

Interventions

OTHERBotulinum Toxin Type A

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

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

Sponsors

Hams Hamed Abdelrahman
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in scar appearanceBaseline, 1 month, 3 months, 6 monthsThe 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 widthBaseline, 1 month, 3 months, 6 monthsThe mean wound width will be measured using a graduated Vernier caliper

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026