Microbotox for Lower Face Rejuvenation

Therapy Clinical Trial

Official title:

"Microbotox" Versus Intramuscular Botulinum Toxin in Lower Face Rejuvenation: A Crossover Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03189082
• Other study ID #: USJ-04
• Status: Completed
• Phase: N/A
• First received: June 9, 2017
• Last updated: October 5, 2017
• Start date: August 10, 2017
• Est. completion date: October 4, 2017

Study information

• Verified date: October 2017
• Source: St Joseph University, Beirut, Lebanon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 4, 2017
• Est. primary completion date: September 10, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Botulinum Toxin
• Neck
• Rejuvenation
• Therapy

Intervention

Procedure:
• Microbotox
Microbotox is the injection of multiple microdroplets of diluted botulinum toxin into the dermis of the lower face

Locations

Country	Name	City	State
Lebanon	Hotel Dieu De France	Beirut	Aschrafieh

Sponsors (1)

Lead Sponsor	Collaborator
St Joseph University, Beirut, Lebanon

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neck volume using a validated scale from the Summit Scale II	The assessment will be done by 3 plastic surgeons. Pre and post injection scores will be calculated by the independent evaluators based on the photographic scale. The 3 evaluators will be blinded to the pre or post injection status of the photos.; No Sagging; Mild Sagging; Moderate Sagging; Severe Sagging; Very Severe Sagging	15-25 days post treatment
Primary	Jowls at rest using a validated scale from the Summit Scale II	The assessment will be done by 3 plastic surgeons. Pre and post injection scores will be calculated by the independent evaluators based on the photographic scale. The 3 evaluators will be blinded to the pre or post injection status of the photos; No Sagging; Mild Sagging; Moderate Sagging; Severe Sagging; Very Severe Sagging	15-25 days post treatment
Primary	Marionette lines at rest using a validated scale from the Summit Scale II	The assessment will be done by 3 plastic surgeons. Pre and post injection scores will be calculated by the independent evaluators based on the photographic scale. The 3 evaluators will be blinded to the pre or post injection status of the photos; No visible folds: continuous skin lines; Shallow but visible folds with slight indentation; Moderately deep folds, clear feature at normal appearance, but not when stretched; Very long and deep folds, prominent facial feature; Extremely long and deep folds; detrimental facial appearance	15-25 days post treatment
Primary	Oral commissures at rest using a validated scale from the Summit Scale II	The assessment will be done by 3 plastic surgeons. Pre and post injection scores will be calculated by the independent evaluators based on the photographic scale. The 3 evaluators will be blinded to the pre or post injection status of the photos; No Downturn; Mild Downturn; Moderate Downturn; Severe Downturn; Very Severe Downturn	15-25 days post treatment
Primary	Platysmal bands at maximal contraction using a validated scale	The assessment will be done by 3 plastic surgeons. Pre and post injection scores will be calculated by the independent evaluators based on the photographic scale. The 3 evaluators will be blinded to the pre or post injection status of the photos; No relevant prominence of platysmal bands; Mild prominence of platysmal bands; Moderate prominence of platysmal bands; Severe prominence of platysmal bands; Very severe prominence of platysmal bands	15-25 days post treatment
Primary	Platysmal bands at rest using a validated scale	The assessment will be done by 3 plastic surgeons. Pre and post injection scores will be calculated by the independent evaluators based on the photographic scale.; No platsymal bands visible at rest; Mild platysmal bands evident at rest. Bands do not appear along the full length of the neck.; Mild platysmal bands evident along the full length of the neck at rest, less than 5 mm of elevation from the surrounding tissue.; Moderate platsymal bandsvisible at rest along the full length of the neck, elevation at least 5 mm from the surrounding tissue.; Severe platsymal bands along the full length of the neck at rest, elevation at least 5 mm from the surrounding tissue, with additional soft tissue ptotic banding present laterally	15-25 days post treatment
Primary	Mandibular definition change with maximal contraction will be assessed by a 2-point scale	The assessment of the pre-injection photos will be done by 3 plastic surgeons.; Mandibular contour does not worsen with platysmal contraction; Mandibular contour worsen with platysmal contraction	15-25 days post treatment
Secondary	Investigators Global Aesthetic Improvement Scale	Improvement in Overall appearance (global neck, jowls, skin laxity, platysmal bands, mandibular contour), as assessed by the investigators using the Global Aesthetic Improvement Scale (GAIS). GAIS will be completed based on photographic assessment comparing post-treatment photos taken at day 15-25 post intervention to baseline photos, to assess overall aesthetic improvement. The GAIS is a 5-point scale (1-5) as follows: Very Much Improved: optimal cosmetic results; Much Improved: marked improvement in appearance from initial condition but not completely optimal; Improved: obvious improvement in appearance from initial condition but additional treatments are advised; No Change: the appearance is the same as the original condition; Worse: the appearance is worse from the original condition	15-25 days post treatment
Secondary	Subject Global Aesthetic Improvement Scale	Improvement in Overall appearance (global neck, jowls, skin laxity, platysmal bands, mandibular contour), as assessed by the subject using the Global Aesthetic Improvement Scale (GAIS). GAIS will be completed based on a live assessment of the subject with a mirror in hand for real time assessment and and a photographic assessment comparing post-treatment photos taken at day 15-25 post intervention to baseline photos, to assess overall aesthetic improvement. The GAIS is a 5-point scale (1-5) as follows: Very Much Improved: optimal cosmetic results; Much Improved: marked improvement in appearance from initial condition but not completely optimal; Improved: obvious improvement in appearance from initial condition but additional treatments are advised; No Change: the appearance is the same as the original condition; Worse: the appearance is worse from the original condition	15-25 days post treatment
Secondary	Patient satisfaction	Patient satisfaction will be determined by a questionnaire completed at 15-25 days post-treatment. Subjects will indicate how satisfied they are on a 4-point scale (1-4) as follow: Very Satisfied; Satisfied; Dissatisfied; Very Dissatisfied.	15-25 days post treatment
Secondary	Patient willingness to repeat the procedure	Patient willingness to repeat the procedure will be assessed by a simple question with a Yes or No response	15-25 days post treatment
Secondary	Patient willingness to recommend the procedure	Patient willingness to recommend the procedure to a friend will be assessed by a simple question with a Yes or No response	15-25 days post treatment
Secondary	Assessment of Pain during treatment	Subjects' pain during the treatment will be recorded using a validated Numeric Rating Scale (0-10), with 0 representing no pain and 10 representing the worst pain possible	Immediately after the treatment