Clinical trial NCT06465056: Use of Botulinum Toxin A in Direct Eyebrow Lift Scar
Official title: Use of Botulinum Toxin A in Direct Eyebrow Lift Scar: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Skin Scarring
Eyebrow Ptosis
Keywords: Botulinum Toxin A
Direct eyebrow lift
Eyebrow scar
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: University of Campinas, Brazil
name: Faculdade de Medicina do ABC
First posted: 2024-06-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Scar evaluation 1
timeFrame: One month, three months and six months after surgery
measure: Scar evaluation 2
timeFrame: One month, three months and six months after surgery
measure: Scar evaluation 3
timeFrame: One month, three months and six months after surgery
measure: Scar evaluation 4
timeFrame: One month, three months and six months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Ophthalmology Dept. University of Sao Paulo General Hospital
city: São Paulo
country: Brazil
facility: University of São Paulo (Clinical Hospital)
Study officials:
References: