The Impact of Botulinum Toxin on Brow Height and Morphology: A Randomized Controlled Trial

St Joseph University, Beirut, Lebanon

Status and phase: Unknown; Phase 4

Conditions: Brow Lifting

Treatments: Procedure: Lateral orbicularis + corrugator injection; Procedure: lateral orbicularis injection; Drug: Dysport

Study type: Interventional

Funder types: Other

Identifiers

NCT02942303

USJ-03

Details and patient eligibility

About

The purpose of this study is to describe three safe and reproducible techniques for brow lifting using botulinum toxin. It will also describe the effect of 2 techniques on the eyebrow shape using quantitative, objective measurements and satisfaction scales.

Enrollment: 30 estimated patients

Sex: Female

Ages: 28 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Consecutive 30 female patients presenting to our clinic for brow lifting with botulinum toxin will be randomized to receive one of the two injection techniques

Exclusion criteria

• Patients with previous periorbital/forehead surgery
• Patients who plucked the upper eyebrow margin
• Patients with eyebrow tatoos
• Patients with upper face botulinum toxin injection in the past 12 months
• Patients with resorbable upper face fillers injection in the past 12 months
• Patients with previous permanent upper face fillers injection
• Pregnant patients
• Lactating patients
• Patients with preexisting neuromuscular conditions (myasthenia gravis, Eaton Lambert syndrome)
• Patients using medication that could potentiate the effect of botulinum (ex: aminoglycoside antibiotics)
• Patients with sensitivity to botulinum toxin or human albumin

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

30 participants in 2 patient groups

Technique 1: Lateral orbicularis injections

Active Comparator group

Description:

5 equally spaced injections will be placed intramuscularly into the orbicularis under the lateral eyebrow starting lateral to the level of the lateral limbus and extending to the level of the inferior orbital rim.

Treatment:

Drug: Dysport

Procedure: lateral orbicularis injection

2. Technique 2: Lateral orbicularis and Corrugator injections

Active Comparator group

Description:

5 equally spaced injections will be placed intramuscularly into the orbicularis under the lateral eyebrow starting lateral to the level of the lateral limbus and extending to the level of the inferior orbital rim. In addition, 2 injections will be placed into the corrugator at the medial brow

Treatment:

Drug: Dysport

Procedure: Lateral orbicularis + corrugator injection