Use of Botulinum Toxin A in Direct Eyebrow Lift Scar

Skin Scarring Clinical Trial

Official title:

Use of Botulinum Toxin A in Direct Eyebrow Lift Scar: a Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06465056
• Other study ID #: 73675523.7.0000.0068
• Status: Recruiting
• Phase: Phase 2
• Start date: January 1, 2024
• Est. completion date: January 1, 2026

Study information

• Verified date: June 2024
• Source: University of Sao Paulo
• Contact: Renata Lemos
• Phone: (11) 2661-7217
• Email: rdinizlemos[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cicatrix
• Skin Scarring

Intervention

Drug:
• Botulinum toxin type A
Botulinum toxin application between 3-14 days after direct eyebrow lift surgery.

Locations

Country	Name	City	State
Brazil	Ophthalmology Dept. University of Sao Paulo General Hospital	Sao Paulo
Brazil	University of São Paulo (Clinical Hospital)	São Paulo

Sponsors (3)

Lead Sponsor	Collaborator
University of Sao Paulo	Faculdade de Medicina do ABC, University of Campinas, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scar evaluation 1	Eyebrow direct lift scar evaluation, comparing botulinum toxin A side with saline side, using the following assessment scale: Visual Analogue Scale Score (VAS). The VAS is described as a quick and practical way of evaluating the patient's experience in relation to pain, on a scale of 0 to 100 millimeters, ranging from no pain to the worst pain imaginable.17 Due to the ease and simplicity of its application, it is used in several studies to evaluate various parameters, even if not consistent with their original validation. Here it will be using meaning 0 (no scar) and 100 milimeters (worst scar imaginable).	One month, three months and six months after surgery
Primary	Scar evaluation 2	Eyebrow direct lift scar evaluation, comparing botulinum toxin A side with saline side, using the following assessment scale: Vancouver Scar Scale (VSS). The VSS ranges from 0 (best) to 13 (worst) points, evaluating vascular distribution, thickness, flexibility and pigmentation.	One month, three months and six months after surgery
Primary	Scar evaluation 3	Eyebrow direct lift scar evaluation, comparing botulinum toxin A side with saline side, using the following assessment scale: Stony Brook Scar Evaluation Scales (SBSESs). The SBSES was developed for short-term assessment of repaired burns, and is described as useful for assessment of suture scars. It consists of five indicators: length, elevation or depression, color, suture or staple marks and general appearance. Your score ranges from 0 (worst) to 5 (best)	One month, three months and six months after surgery
Primary	Scar evaluation 4	Eyebrow direct lift scar evaluation, comparing botulinum toxin A side with saline side, using the following assessment scale: Patient and Observer Scar Assessment Scale (POSAS).; POSAS was developed in 2004 and is the first scale to consider the perspective of the patient and the evaluator. It is useful in evaluating postoperative and linear scars, ranging from 5 (worst) to 50 (best). It encompasses physical properties of scars such as vascularity, pigmentation, thickness, relief and flexibility, in addition to two patient symptoms, pain and itching.	One month, three months and six months after surgery