- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03189082
Microbotox for Lower Face Rejuvenation
"Microbotox" Versus Intramuscular Botulinum Toxin in Lower Face Rejuvenation: A Crossover Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Aschrafieh
-
Beirut, Aschrafieh, Lebanon, 00961
- Hotel Dieu de France
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
|
Microbotox is the injection of multiple microdroplets of diluted botulinum toxin into the dermis of the lower face
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neck volume using a validated scale from the Summit Scale II
Time Frame: 15-25 days post treatment
|
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.
|
15-25 days post treatment
|
Jowls at rest using a validated scale from the Summit Scale II
Time Frame: 15-25 days post treatment
|
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
|
15-25 days post treatment
|
Marionette lines at rest using a validated scale from the Summit Scale II
Time Frame: 15-25 days post treatment
|
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
|
15-25 days post treatment
|
Oral commissures at rest using a validated scale from the Summit Scale II
Time Frame: 15-25 days post treatment
|
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
|
15-25 days post treatment
|
Platysmal bands at maximal contraction using a validated scale
Time Frame: 15-25 days post treatment
|
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
|
15-25 days post treatment
|
Platysmal bands at rest using a validated scale
Time Frame: 15-25 days post treatment
|
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.
|
15-25 days post treatment
|
Mandibular definition change with maximal contraction will be assessed by a 2-point scale
Time Frame: 15-25 days post treatment
|
The assessment of the pre-injection photos will be done by 3 plastic surgeons.
|
15-25 days post treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Investigators Global Aesthetic Improvement Scale
Time Frame: 15-25 days post treatment
|
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:
|
15-25 days post treatment
|
Subject Global Aesthetic Improvement Scale
Time Frame: 15-25 days post treatment
|
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:
|
15-25 days post treatment
|
Patient satisfaction
Time Frame: 15-25 days post treatment
|
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:
|
15-25 days post treatment
|
Patient willingness to repeat the procedure
Time Frame: 15-25 days post treatment
|
Patient willingness to repeat the procedure will be assessed by a simple question with a Yes or No response
|
15-25 days post treatment
|
Patient willingness to recommend the procedure
Time Frame: 15-25 days post treatment
|
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
|
Assessment of Pain during treatment
Time Frame: Immediately after the 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
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- USJ-04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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