Jawline and Neck Appearance
Conditions
Keywords
AURA Study, Jaw area and Neck Appearance, onabotulinumtoxinA, JUVÉDERM
Brief summary
The goal of this study is to evaluate overall participant satisfaction with the jawline and neck. Participants will receive select Juvéderm products and onabotulinumtoxinA in the jaw area and neck per eligibility criteria. The study will measure changes in psychological function, satisfaction with lower face and jawline and skin appearance. Participants will attend visits during the study at a clinical site. The effects of the treatment will be checked by medical assessments, vital signs, physical examinations, checking for side effects, and completing questionnaires.
Interventions
Sponsors
AbbVie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Moderate or severe transverse neck lines based on investigator's live assessment * Moderate or severe loss of jawline definition based on investigator's live assessment. * Moderate or severe platysma prominence based on investigator's live assessment.
Exclusion criteria
* History of or current medical condition that may put the subject at increased medical risk with exposure to BOTOX, or any other condition that might interfere with neuromuscular function. * History of or current symptoms of dysphagia. * History of severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies. * History of hypersensitivity or allergy to any botulinum toxin serotype, Streptococcal or gram-positive bacterial proteins, lidocaine, HA products, any other excipients or constituents of the study drug, device, and/or other products in the same class. * History of or tendency for keloid formation, hyperpigmentation, or hypertrophic scarring.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Response of Satisfied or Very Satisfied on Appearance of Neck and Lower Face Questionnaire (ANLFQ): Satisfaction Follow-Up | Day 104 | The ANLFQ is a 5-point scale that assesses participant satisfaction. Response options range from Very satisfied to Very dissatisfied. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Participant's Rasch-transformed Score of the FACE-Q Psychological Function | Up to approximately 104 days | The FACE-Q Psychological Function scale assesses the psychological impact of facial appearance. The Rasch-transformed summary score ranges from worst to best. |
| Change From Baseline in Participant's Rasch-transformed Score of the FACE-Q Satisfaction With Lower Face and Jawline | Up to approximately 104 days | FACE-Q Satisfaction assesses participant satisfaction with the appearance of their lower face and jawline. The Rasch-transformed summary score ranges from worst to best. |
| Change From Baseline in Participant's Rasch-transformed Score of the SKIN-Q - Skin Looks | Up to approximately 104 days | SKIN-Q - Skin Looks assesses participant's satisfaction with how their skin looks. Rasch transformed scores ranges from worst to best. |
| Change From Baseline in Participant's Allergan Facial Confidence Scale (AFCS) - Confidence (Treatment Area) Total Score | Up to approximately 104 days | AFCS - Confidence (Treatment Area) is a questionnaire that assesses the participant's confidence in the appearance of the treatment area. 4-point response option ranges from Very Confident to Not at all confident. |
| Percentage of Participants With Response of Improved or Much Improved on Investigator Global Aesthetic Improvement Scale (GAIS) | Up to approximately 104 days | GAIS is a clinician-rated 5-point scale that assesses of overall aesthetic improvement compared to baseline. Scores range from "Much improved" to "Much worse". |
| Percentage of Participants With Response of Satisfied or Very Satisfied (or Agree or Definitely Agree) on Allergan Facial Satisfaction Scale (AFSS) - Natural Look and Feel | Up to approximately 104 days | AFSS assesses participant satisfaction. Scores range from "Very satisfied" to" Very dissatisfied". |
Contacts
CONTACTABBVIE CALL CENTER
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed