Use of Botulinum Toxin A in Direct Eyebrow Lift Scar

University of Sao Paulo

Status and phase: Enrolling; Phase 2

Conditions: Skin Scarring; Eyebrow Ptosis

Treatments: Drug: Botulinum toxin type A

Study type: Interventional

Funder types: Other

Identifiers

NCT06465056

73675523.7.0000.0068

Details and patient eligibility

About

Prospective, controlled and randomized study in which participants indicated for surgery to direct eyebrow lift will be randomized into two groups. In addition to surgery, the patients will be treated with botulinum toxin in one eyebrow and saline (placebo) in the other site. The patients participate as treatment and placebo at the same time. Assessments will be carried out through non-invasive exams.

Full description

A component of eyebrow ptosis, part of the natural aging process, with or without asymmetries, is found in the majority of patients who seek the blepharoplasty procedure.

There are several procedures to address this condition, but none of them is undoubtedly superior to the others. The direct eyebrow lift technique is known for providing good eyebrow suspension, predictable results and relatively low complexity surgery, which can be performed with local anesthesia.

However, the biggest concern for surgeons and patients is the final appearance of the scar, which will be in a visible area of the face. Botulinum toxin A has been used in recent studies precisely to improve the appearance of scars. Previous studies mainly evaluated traumatic lacerations and post-tumor excision reconstructions, obtaining positive results, with an improvement in the appearance of the wounds in patients who used the medication. It is a safe drug, used for several years for other purposes and without serious adverse effects according to these studies.

The objective of this study is to compare the use of botulinum toxin A versus 0.9% saline solution in the healing of direct eyebrow lift surgery.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients over 18 years of age with indication for direct eyebrow lift surgery.

Exclusion criteria

• Vulnerable groups: children, pregnant women and immunosuppressed patients
• Allergy to botulinum toxin A
• Patients under 18 years old
• Women who are breastfeeding
• Patients with muscular/neuromuscular diseases such as myasthenia gravis and amyotrophic lateral sclerosis
• Patients who underwent botulinum toxin A injection in the last 6 months prior to surgery
• Patients with a history of radiotherapy, chemotherapy or hematological disorders
• Refusal to participate in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Right side treatment

Active Comparator group

Description:

Patients receive botulinum toxin A in right side eyebrow scar and saline in left side scar.

Treatment:

Drug: Botulinum toxin type A

Left side treatment

Active Comparator group

Description:

Patients receive botulinum toxin A in left side eyebrow scar and saline in right side scar.

Treatment:

Drug: Botulinum toxin type A