Study to Assess Participant Satisfaction After Jawline and Neck Treatment
ConditionJawline and Neck Appearance
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age22-65
SponsorAbbVie
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
OnabotulinumtoxinA
DrugInjection
SKINVIVE
DeviceInjection
VOLUX
DeviceInjection
VOLUMA
DeviceInjection
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: JUVÉDERM Products Plus OnabotulinumtoxinAExperimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
Percentage of Participants With Response of Satisfied or Very Satisfied on Appearance of Neck and Lower Face Questionnaire (ANLFQ): Satisfaction Follow-Up
The ANLFQ is a 5-point scale that assesses participant satisfaction. Response options range from Very satisfied to Very dissatisfied.
Time frame
Day 104Secondary outcomes
1
Change From Baseline in Participant's Rasch-transformed Score of the FACE-Q Psychological Function
The FACE-Q Psychological Function scale assesses the psychological impact of facial appearance. The Rasch-transformed summary score ranges from worst to best.
Time frame
Up to approximately 104 days2
Change From Baseline in Participant's Rasch-transformed Score of the FACE-Q Satisfaction With Lower Face and Jawline
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.
Time frame
Up to approximately 104 days3
Change From Baseline in Participant's Rasch-transformed Score of the SKIN-Q - Skin Looks
SKIN-Q - Skin Looks assesses participant's satisfaction with how their skin looks. Rasch transformed scores ranges from worst to best.
Time frame
Up to approximately 104 days4
Change From Baseline in Participant's Allergan Facial Confidence Scale (AFCS) - Confidence (Treatment Area) Total Score
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.
Time frame
Up to approximately 104 days Source ClinicalTrials.gov