Facial Contouring
Conditions
Keywords
Facial Contouring, OnabotulinumtoxinA, JUVEDERM Products, KYBELLA, CoolSculpting Elite, SkinMedica
Brief summary
A study to evaluate overall participant satisfaction of face and neck appearance after treatment with onabotulinumtoxinA, JUVÉDERM® products, KYBELLA, CoolSculpting Elite, and select SkinMedica products in a diverse population.
Interventions
Sponsors
AbbVie
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Applies to All Participants: * Must meet at least 1 of the following criteria for BOTOX UFL treatment per investigator's assessment: * Moderate or severe on Allergan Glabellar Line Severity Scale at maximum furrow * Moderate or severe on Forehead Line Severity Scale at maximum brow elevation and Moderate or Severe on Allergan Glabellar Line Severity Scale at maximum furrow * Moderate or severe on Lateral Canthal Line Severity Scale at maximum contraction (identical severity on both sides) * Must meet at least 3 of the following criteria for treatment in the face with at least 2 JUVÉDERM products, per investigator's assessment: * Moderate or severe on Allergan Loss of Jawline Definition Scale * Moderate or severe on Allergan Chin Retrusion Scale * Moderate, significant, or severe on Midface Volume Deficit Scale * Moderate or severe on Nasolabial Fold Severity Scale * Moderate or severe for both eyes on Allergan Infraorbital Hollows Scale * Minimal, mild, or moderate on 5-point Allergan Lip Fullness Scale * Moderate or severe on Allergan Cheek Smoothness Scale * Minimal, moderate, or severe on Allergan Temple Hollowing Scale Applies only to participants who will be treated for submental fullness: \- Moderate or severe on the Clinician-reported Submental Fat Rating Scale (for KYBELLA treatment) or Moderate, severe, or extreme (For CoolSculpting Elite treatment) per investigator's assessment.
Exclusion criteria
* History of medical condition that may put the subject at increased medical risk with exposure to OnabotulinumtoxinA, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function. * History of hypersensitivity or allergy to any botulinum toxin serotype, Streptococcal protein, lidocaine (or any amide-based anesthetics), HA products, any other excipients or constituents of the study drug, device, SkinMedica products and/or other products in the same class. * Marked facial asymmetry (e.g., asymmetry in eyebrow and/or eyelid position, asymmetrical smile or significant asymmetry in the lower face), facial nerve palsy, dermatochalasis, deep dermal scarring, excessively thick sebaceous skin, excessively photodamaged skin, or the inability to substantially lessen facial lines even by physically spreading them apart. * Previous plastic surgery, tissue grafting, permanent facial implants (e.g., polymethylmethacrylate, silicone, polytetrafluoroethylene), or tissue augmentation with silicone, fat, or other permanent dermal fillers of the face and/or neck or plan to undergo any of these procedures at any time during the study. * Prior exposure to botulinum toxin of any serotype to any part of the body within 6 months prior to screening. * Prior treatment with non-permanent soft tissue fillers or fat-reducing injectables in the face or neck within 12 months prior to screening. * Prior treatment with energy-based devices (e.g., intense pulsed light, Clear + Brilliant®, monopolar radiofrequency, microfocused ultrasound, etc.,) or other noninvasive fat reduction procedure and/or skin-tightening laser treatments in the face or neck within 6 months prior to screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in the Participant's Rasch-Transformed Score of the FACE-Q Satisfaction with Facial Appearance Scale at the Final Visit | Up to approximately 284 days | The FACE-Q Satisfaction with Facial Appearance is a validated questionnaire that asks participants to report their level of satisfaction with the appearance of their face. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in the Participant's Rasch-Transformed Score of the FACE-Q Psychological Function Scale at the Final Visit | Up to approximately 284 days | The FACE-Q Psychological Function is a validated questionnaire that asks participants to report their level of satisfaction with psychological function. |
| Change from Baseline in the Participant's Rasch-Transformed Score of the FACE-Q Social Function Scale at the Final Visit | Up to approximately 284 days | The FACE-Q Social Function Scale is a validated questionnaire that asks participants to report their level of satisfaction with social function. |
| Change from Baseline in the Participant's Rasch-Transformed Score of the SKIN-Q Scale at the Final Visit | Up to approximately 284 days | The SKIN-Q Scale is a validated questionnaire that asks participants to report their level of satisfaction with skin quality. |
Countries
United States
Contacts
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed