Microbotox for Lower Face Rejuvenation

NCT03189082 | Completed

• 1 other identifier: USJ-04
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Botulinum Toxin; Rejuvenation; Therapy; Neck

Outcome Measures

Primary Outcomes (7)

• 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. 1. No Sagging 2. Mild Sagging 3. Moderate Sagging 4. Severe Sagging 5. Very Severe Sagging

  15-25 days post treatment

• 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 1. No Sagging 2. Mild Sagging 3. Moderate Sagging 4. Severe Sagging 5. Very Severe Sagging

  15-25 days post treatment

• 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 1. No visible folds: continuous skin lines 2. Shallow but visible folds with slight indentation 3. Moderately deep folds, clear feature at normal appearance, but not when stretched 4. Very long and deep folds, prominent facial feature 5. Extremely long and deep folds; detrimental facial appearance

  15-25 days post treatment

• 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 1. No Downturn 2. Mild Downturn 3. Moderate Downturn 4. Severe Downturn 5. Very Severe Downturn

  15-25 days post treatment

• 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 1. No relevant prominence of platysmal bands 2. Mild prominence of platysmal bands 3. Moderate prominence of platysmal bands 4. Severe prominence of platysmal bands 5. Very severe prominence of platysmal bands

  15-25 days post treatment

• 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. 1. No platsymal bands visible at rest 2. Mild platysmal bands evident at rest. Bands do not appear along the full length of the neck. 3. Mild platysmal bands evident along the full length of the neck at rest, less than 5 mm of elevation from the surrounding tissue. 4. Moderate platsymal bandsvisible at rest along the full length of the neck, elevation at least 5 mm from the surrounding tissue. 5. 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

• 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. 1. Mandibular contour does not worsen with platysmal contraction 2. Mandibular contour worsen with platysmal contraction

  15-25 days post treatment

Secondary Outcomes (6)

• Investigators Global Aesthetic Improvement Scale

  15-25 days post treatment

• Subject Global Aesthetic Improvement Scale

  15-25 days post treatment

• Patient satisfaction

  15-25 days post treatment

• Patient willingness to repeat the procedure

  15-25 days post treatment

• Patient willingness to recommend the procedure

  15-25 days post treatment

Study Arms (1)

Intervention group

EXPERIMENTAL

Procedure: Microbotox

Interventions

Microbotox PROCEDURE

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

Intervention group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St Joseph University, Beirut, Lebanon: lead

Study Sites (1)

Hotel Dieu De France

Beirut, Aschrafieh, 00961, Lebanon

Location

Related Publications (1)

• 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.

  PMID: 29879010 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: June 9, 2017
• First Posted: June 16, 2017
• Study Start: August 10, 2017
• Primary Completion: September 10, 2017
• Study Completion: October 4, 2017
• Last Updated: October 6, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)