Microbotox for Lower Face Rejuvenation

St Joseph University, Beirut, Lebanon

Status: Completed

Conditions: Neck; Botulinum Toxin; Therapy; Rejuvenation

Treatments: Procedure: Microbotox

Study type: Interventional

Funder types: Other

Identifiers

NCT03189082

USJ-04

Details and patient eligibility

About

The purpose of this study is to evaluate the efficiency of the intradermal injection of botulinum toxin in lower face rejuvenation. The study will also compare this intervention with the "Nefertiti Lift" intramuscular injection technique.

Full description

The abobotulinumtoxinA will be used for the intervention. The abobotulinumtoxinA will be prepared by adding 2.5 cc of normal saline to a 500-unit Dysport© (Ipsen Ltd, Berks, UK) vial. Further dilution to the appropriate Microbotox concentration will be done in the syringe itself. Each 1mL syringe of Microbotox solution will contain 20-28 units of onabotulinumtoxinA per mL of solution.

Preinjection frontal, oblique and lateral patient pictures will be taken (at rest and with contraction)

Injection points:

A series of 100-150 intradermal microdroplets injection points 1 cm apart will be delivered in the lower face. The area to be injected is bounded by a line 3 fingerbreadths above and parallel to the lower border of the mandible, 1 fingerbreadth posterior to the depressor anguli oris, and all the way down over the cervicomental angle and anterior neck to the upper border of the clavicle, and posteriorly to the anterior border of the sternocleidomastoid.

In the average patient, 2 syringes of 28 units per mL of microbotox will be used to cover the entire area.

In heavier necks, 3 syringes of 28 units per mL will be used. In thinner necks, 2 syringes of 20 units per mL will be used.

Follow up will be done at 15 days for post injection pictures. A total of 15 patients will be recruited

Enrollment: 15 patients

Sex: Female

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Female patients presenting to our clinic for neck rejuvenation who:

• Were deemed nonsurgical candidates for neck rejuvenation
• Were not willing to undergo invasive surgical procedures
• Had a medical contraindication to surgery

Exclusion criteria

• Patients with lower face botulinum toxin injection in the past 12 months
• Patients with resorbable lower face fillers injection in the past 12 months
• Patients with previous permanent lower 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: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Intervention group

Experimental group

Treatment:

Procedure: Microbotox