Facial Wrinkles
Conditions
Brief summary
The aim of this prospective, randomized, double-blind, intraindividual split face study will be to compare onabotulinumtoxinA to incobotulinumtoxinA for the correction of facial wrinkles using a 1:1 dose ratio.
Detailed description
Patients will be randomized to which side of the face will be injected with onabotulinumtoxinA and incobotulinumtoxinA. A total dose of 22.5 units of onabotulinumtoxinA and 22.5 units of incobotulinumtoxinA will be administered at baseline to the respected side of the face. One vial (100 MU) of BoNTA will be reconstituted with 2.0 mL of 0.9% sterile saline solution. Similarly, one vial (100 MU) of BTXCo will be reconstituted with 2.0 mL of 0.9% sterile saline solution. 2.5 units of the respective neurotoxin will be administered to three sites in the crow's feet area on each side (7.5 units total for one side), 2.5 units to two locations of the forehead on each side (5 units total for one side), and 5.0 units to two locations in the glabella on each side(10 units total for one side). The duration of the study will be 4 months. The followup visits after the initial injections will be at 3 days, 2 weeks, 3 months, and 4 months after the initial treatment. At each of these visits, standardized digital photographs of the treated facial area will be taken. Both static and dynamic photos will be taken of each region. At the conclusion of the study, three independent raters will individually perform blind assessments of the photographs according to the Validated Assessment Scaled for the Upper Face published by Flynn et al 2012.
Interventions
DRUGXeomin to right side of face in half of the subjects; Xeomin to left side of face in the other half of subjects
Subjects were randomized to which side of the face would be treated with Xeomin.
DRUGBotox to right side of face in half of the subjects (randomized); Botox to the left side of the face in the other half of subjects
Subjects were randomized to which side of the upper face would be treated with Botox
Sponsors
YMD Eye and Face
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* males and females age 18 or older.
Exclusion criteria
* Previous treatment with a neuromodulator in the last 6 months * previous brow lift * currently pregnant or breastfeeding * a history of neurological disease or deficit * an active facial skin infection * an allergy to neuromodulators
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Wrinkles Score | Preinjection assessment; assessment at 3 days, 2 weeks, 3 months, 4 months post-injection | Objective assessment of change in wrinkles score pre and post injection of the crow's feet, glabella, and forehead using the Validated Assessment Scaled for the Upper Face published by Flynn et al. 2012. At the end of the study the delta wrinkle score from pre-injection to each followup assessment for each area will be calculated. |
Countries
United States
Outcome results
None listed