Use of Botulinum Toxin A in Direct Eyebrow Lift Scar

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

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.

Study Overview

• Status: Recruiting
• Conditions: Skin Scarring; Eyebrow Ptosis
• Intervention / Treatment: Drug: Botulinum toxin type A

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Renata Lemos; Phone Number: (11) 2661-7217; Email: rdinizlemos@gmail.com

Study Locations

• Brazil
  • Sao Paulo, Brazil, 05403010
    • Recruiting
    • Ophthalmology Dept. University of Sao Paulo General Hospital
    • Principal Investigator: Suzana Matayoshi, MD
  • São Paulo, Brazil, 05403-010
    • Recruiting
    • University of São Paulo (Clinical Hospital)
    • Contact: Renata D. Lemos, MD, MMed; Email: rdinizlemos@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Right side treatment; Patients receive botulinum toxin A in right side eyebrow scar and saline in left side scar.	Drug: Botulinum toxin type A; Botulinum toxin application between 3-14 days after direct eyebrow lift surgery.
Active Comparator: Left side treatment; Patients receive botulinum toxin A in left side eyebrow scar and saline in right side scar.	Drug: Botulinum toxin type A; Botulinum toxin application between 3-14 days after direct eyebrow lift surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Collaborators: University of Campinas, Brazil; Faculdade de Medicina do ABC

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: May 26, 2024
• First Submitted That Met QC Criteria: June 16, 2024
• First Posted (Actual): June 18, 2024

Study Record Updates

• Last Update Posted (Actual): June 18, 2024
• Last Update Submitted That Met QC Criteria: June 16, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Botulinum Toxin A; Direct eyebrow lift; Eyebrow scar
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: 73675523.7.0000.0068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No