Study to Evaluate Subject Satisfaction With Facial Appearance and Impact of Combined Facial Treatment

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to quantify the psychological, social, and emotional impact of comprehensive aesthetic treatment with a portfolio of the Sponsor's products by measuring the change in subject's satisfaction with facial appearance from baseline (before any treatment) to the final study visit

Official Title
-----------------
Prospective, Multi-site Study to Evaluate Subject Satisfaction With Facial Appearance Overall and the Aesthetic and Psychosocial Impact of Combined Facial Treatment

Conditions
-----------------
Facial Rhytides, Skin Folds, Loss of Volume and Skin Quality

Intervention / Treatment
-----------------
* Device: JUVÉDERM
* Drug: BOTOX
* Device: HArmonyCA Lidocaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Accept the obligation not to receive any other facial procedures or treatments at any time during the study that are not related to the study Women of childbearing potential must have a negative urine pregnancy test before each injectable treatment and practice a reliable method of contraception throughout the study Willing to avoid direct and prolonged sun exposure to the facial skin, which includes tanning beds, for the duration of the study Must qualify to receive BOTOX treatments, in at least one area, as per the approved Product Monograph including treatment of hyperkinetic lines for the glabellar, crow's feet, and forehead lines: Glabellar injection: glabellar rhytides characterized as moderate or severe during maximum muscle contraction on the evaluation of the facial wrinkle scale (FWS) CFLs characterized as 2 (moderate) or 3 (severe) during maximum smile on the evaluation of the FWS Forehead lines (FHLs) of moderate to 3 severe rating at maximum eyebrow elevation as assessed using the FWS Exclusion Criteria: Body mass index (BMI) > 30 kg/m2 Known allergy or sensitivity to the study products or their components Pregnant, lactating, or planning to become pregnant at any time during the study Received BOTOX or treatment with any other botulinum toxin product for any condition within 6 months before enrollment Received (or is planning to receive) anti-coagulation, antiplatelet or thrombolytic medications (e.g., warfarin) or other substances known to increase coagulation time from 10 days prior to injection and up to 3 days post-injection Undergone plastic surgery of the face and/or neck, tissue grafting, or tissue augmentation with silicone, fat, or other permanent dermal fillers, or be planning to undergo any of these procedures at any time during the study Has undergone temporary or semi-permanent facial or neck dermal filler treatment (e.g., hyaluronic acid, calcium hydroxylapatite, poly-L-lactic acid) within 12 months before enrollment Received mesotherapy, skin resurfacing (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, chemical peel, or non-ablative procedures) in the face or neck within 6 months prior to study enrollment Marked facial asymmetry, brow or eyelid ptosis, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin, or an inability to substantially lessen the resting GLs and CFLs/facial rhytides by physically spreading them apart Lip tattoos, facial hair or scars that would interfere with visualization of the lips and perioral area for the effectiveness assessments At any proposed injection site, presence of inflammation, infection at any injection site or systemic infection (study entry may be postponed until one week following recovery), noticeable acne scarring, cancerous or pre-cancerous lesion, or unhealed wound or have undergone radiation treatment in the area to be treated Received any investigational product within 60 days prior to study enrollment or planning to participate in another investigation during the course of this study Current use of oral corticosteroids Current use of nonsteroidal anti-inflammatory drugs (NSAIDs) (e.g., aspirin, ibuprofen), from 10 days prior to injection up to 3 days post-injection Prescription topical retinoid therapy and/or topical hormone cream applied to the face, for potential subjects who have not been on a consistent dose regimen for at least 6 months prior to enrollment and who are unable to maintain regimen for the study Systemic retinoid therapy within one year prior to study enrollment History or current symptoms of dysphagia Medical condition that may increase the risk of exposure to botulinum toxin including diagnosed myasthenia gravis, Eaton-Lambert Syndrome, amyotrophic lateral sclerosis, or any other disease that might interfere with neuromuscular function Profound atrophy/excessive weakness of muscles in target areas of injection History of facial nerve palsy Anticipated need for treatment with botulinum toxin of any serotype for any reason during the study (other than study treatment) Very thin skin in the mid-facial region Tendency to accumulate fluid in the lower eyelids, or large infraorbital fat pads, i.e., significant convexity or projection from the infraorbital fat pads Mid-face volume deficit due to congenital defect, trauma, abnormalities in adipose tissue related to immune-mediated diseases such as generalized lipodystrophy (e.g., juvenile dermatomyositis), partial lipodystrophy (e.g., Barraquer-Simons syndrome), inherited disease, or human immunodeficiency virus-related disease Undergone oral surgery or other dental procedures (e.g., tooth extraction, orthodontia, or implantation) within 30 days prior to enrollment or be planning to undergo any of these procedures during the study Subjects with neuromuscular disorders including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia, and respiratory compromise Subjects with a history of allergies

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HArmonyCA, Juvederm, BOTOX<br>All treatments will be administered according to the respective label and according to an agreed upon treatment plan between the subject and Health Care Provider. If required: HarmonyCA Lidocaine will be administered at Visit 1, Juvéderm filler injections (JUVÉDERM VOLBELLA with Lidocaine, and/or JUVÉDERM VOLIFT with Lidocaine, and/or JUVÉDERM VOLUMA with Lidocaine, and/or JUVÉDERM VOLITE with Lidocaine and/or JUVÉDERM VOLUX with Lidocaine) will be administered at Visit 3, BOTOX will be administered at Visit 5. Touch-ups may be performed as required by subject's treatment plan after each study visit. | Device: JUVÉDERM<br>* JUVÉDERM VOLBELLA with Lidocaine Treatment of any fine lines and medium-sized skin depressions. Can also be used for enhancement and pouting of the lips to correct structural defects such as asymmetry, contour deformities, volume loss. JUVÉDERM VOLIFT with Lidocaine Intended for the treatment of any deep skin depressions due to conditions such as premature aging. Can also be used for face contouring and volume restoration to correct facial structural defects such as asymmetry, contour deformities, volume loss in the lips, cheeks, chin, lower face. JUVÉDERM VOLUMA with Lidocaine Intended to restore volume of the face JUVÉDERM VOLITE with Lidocaine Intended for treatment, by filling, of superficial cutaneous depressions such as fine lines and for additional improvement of skin quality attributes such as hydration and elasticity. JUVÉDERM VOLUX with Lidocaine Intended to restore and generate facial volume in chin and mandible areas<br>Drug: BOTOX<br>* Indicated for the treatment of hyperkinetic facial lines.<br>Device: HArmonyCA Lidocaine<br>* HArmonyCa Lidocaine injectable gel is a dermal filler intended for facial soft tissue augmentation.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the Rasch-transformed score of the FACE-Q Satisfaction with facial appearance overall scale. | Four point ordinal scale measuring the change in subject's satisfaction with facial appearance from baseline (before any treatment) to the final study visit from 1 (Very Dissatisfied) to 4 (Very Satisfied) | Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the Rasch-transformed score of the FACE-Q Satisfaction with age related facial appearance | Four point ordinal scale measuring the change in subject's satisfaction with age related facial appearance from baseline (before any treatment) to the final study visit from 1 (Very Dissatisfied) to 4 (Very Satisfied) | Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months) | 
| Change from baseline in the Rasch-transformed score of the FACE-Q Psychological Function Scale with psychological well-being | Four point ordinal scale measuring the change in subject's psychological wellbeing from baseline (before any treatment) to the final study visit from 1 (Very Dissatisfied) to 4 (Very Satisfied) | Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months) | 
| Change from baseline in the Rasch-transformed score of the FACE-Q Social Function Scale with social function | Four point ordinal scale measuring the change in subject's social function from baseline (before any treatment) to the final study visit from 1 (Very Dissatisfied) to 4 (Very Satisfied) | Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months) | 
| Change from baseline in the Rasch-transformed score of the FACE-Q Satisfaction with skin | Four point ordinal scale measuring the change in subject's satisfaction with skin from baseline (before any treatment) to the final study visit from 1 (Very Dissatisfied) to 4 (Very Satisfied) | Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months) | 
| Change from baseline in the Investigator's assessment using Global Aesthetic Improvement Scale (GAIS) | Five point ordinal scale measuring the change in facial aesthetic improvement from -2 (Much Worse) to 2 (Much Improved) assessed by the Investigator | Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months) | 
| Change from baseline in the Subject's assessment using Global Aesthetic Improvement Scale (GAIS) | Five point ordinal scale measuring the change in facial aesthetic improvement from -2 (Much Worse) to 2 (Much Improved) assessed by the subject | Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months) | 
| Change in subject's satisfaction with appearance of periorbital area as measured by the Periorbital Aesthetic Appearance Questionnaire (PAAQ) | Questionnaire evaluating the subject's overall eye appearance from 0 (Never) to 4 (All of the Time) | Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months) |