Use of Botulinum Toxin A in Direct Eyebrow Lift Scar

NCT ID: NCT06465056

Last Updated: 2024-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2026-01-01

Brief Summary

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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

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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.

Conditions

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Skin Scarring Eyebrow Ptosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Right side treatment

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

Group Type ACTIVE_COMPARATOR

Botulinum toxin type A

Intervention Type DRUG

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

Left side treatment

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

Group Type ACTIVE_COMPARATOR

Botulinum toxin type A

Intervention Type DRUG

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

Interventions

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Botulinum toxin type A

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Campinas, Brazil

OTHER

Sponsor Role collaborator

Faculdade de Medicina do ABC

OTHER

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Suzana Matayoshi

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of São Paulo (Clinical Hospital)

São Paulo, , Brazil

Site Status RECRUITING

Ophthalmology Dept. University of Sao Paulo General Hospital

São Paulo, , Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Renata Lemos

Role: CONTACT

(11) 2661-7217

Facility Contacts

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Renata D. Lemos, MD, MMed

Role: primary

Other Identifiers

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73675523.7.0000.0068

Identifier Type: -

Identifier Source: org_study_id

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