Clinical trial NCT03189082: Microbotox for Lower Face Rejuvenation
Official title: "Microbotox" Versus Intramuscular Botulinum Toxin in Lower Face Rejuvenation: A Crossover Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Botulinum Toxin
Rejuvenation
Therapy
Neck
Lead sponsor: St Joseph University, Beirut, Lebanon
Sponsor class: OTHER
First posted: 2017-06-16
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Neck volume using a validated scale from the Summit Scale II
timeFrame: 15-25 days post treatment
measure: Jowls at rest using a validated scale from the Summit Scale II
timeFrame: 15-25 days post treatment
measure: Marionette lines at rest using a validated scale from the Summit Scale II
timeFrame: 15-25 days post treatment
measure: Oral commissures at rest using a validated scale from the Summit Scale II
timeFrame: 15-25 days post treatment
measure: Platysmal bands at maximal contraction using a validated scale
timeFrame: 15-25 days post treatment
measure: Platysmal bands at rest using a validated scale
timeFrame: 15-25 days post treatment
measure: Mandibular definition change with maximal contraction will be assessed by a 2-point scale
timeFrame: 15-25 days post treatment
Secondary outcomes:
measure: Investigators Global Aesthetic Improvement Scale
timeFrame: 15-25 days post treatment
measure: Subject Global Aesthetic Improvement Scale
timeFrame: 15-25 days post treatment
measure: Patient satisfaction
timeFrame: 15-25 days post treatment
measure: Patient willingness to repeat the procedure
timeFrame: 15-25 days post treatment
measure: Patient willingness to recommend the procedure
timeFrame: 15-25 days post treatment
measure: Assessment of Pain during treatment
timeFrame: Immediately after the treatment
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Hotel Dieu De France
state: Aschrafieh
Study officials:
References:
citation: Awaida CJ, Jabbour SF, Rayess YA, El Khoury JS, Kechichian EG, Nasr MW. Evaluation of the Microbotox Technique: An Algorithmic Approach for Lower Face and Neck Rejuvenation and a Crossover Clinical Trial. Plast Reconstr Surg. 2018 Sep;142(3):640-649. doi: 10.1097/PRS.0000000000004695.