Use of Botulinum Toxin A in Direct Eyebrow Lift Scar

NCT06465056 | Recruiting Phase 2

• 1 other identifier: 73675523.7.0000.0068
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Skin Scarring; Eyebrow Ptosis

Keywords

Botulinum Toxin A; Direct eyebrow lift; Eyebrow scar

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Right side treatment

ACTIVE COMPARATOR

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

Drug: Botulinum toxin type A

Left side treatment

ACTIVE COMPARATOR

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

Drug: Botulinum toxin type A

Interventions

Botulinum toxin type A DRUG

Botulinum toxin application between 3-14 days after direct eyebrow lift surgery.

Left side treatment; Right side treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead
• University of Campinas, Brazil: collaborator
• Faculdade de Medicina do ABC: collaborator

Study Sites (2)

University of São Paulo (Clinical Hospital)

São Paulo, 05403-010, Brazil

RECRUITING

Ophthalmology Dept. University of Sao Paulo General Hospital

São Paulo, 05403010, Brazil

RECRUITING

MeSH Terms

Conditions

Cicatrix

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Central Study Contacts

Renata Lemos

CONTACT

(11) 2661-7217; rdinizlemos@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 26, 2024
• First Posted: June 18, 2024
• Study Start: January 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2026
• Last Updated: June 18, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)