Prospective, Multi-site Study to Evaluate Subject Satisfaction With Facial Appearance Overall and the Aesthetic and Psychosocial Impact of Combined Facial Treatment
Overview
- Phase
- Phase 4
- Intervention
- JUVÉDERM
- Conditions
- Facial Rhytides
- Sponsor
- Allergan
- Enrollment
- 64
- Locations
- 6
- Primary Endpoint
- Change From Baseline in the Rasch-transformed Score of the FACE-Q Satisfaction With Facial Appearance Scale.
- Status
- Completed
- Last Updated
- 10 months ago
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
Investigators
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
Arms & Interventions
HArmonyCA, Juvederm, BOTOX
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.
Intervention: JUVÉDERM
HArmonyCA, Juvederm, BOTOX
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.
Intervention: BOTOX
HArmonyCA, Juvederm, BOTOX
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.
Intervention: HArmonyCA Lidocaine
Outcomes
Primary Outcomes
Change From Baseline in the Rasch-transformed Score of the FACE-Q Satisfaction With Facial Appearance Scale.
Time Frame: Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months)
The FACE-Q questionnaire focuses on patient's satisfaction with facial appearance at the final study visit compared to before starting study treatment and is a 10- item questionnaire. Overall scores range from 0 to 100 with higher scores representing higher satisfaction.
Secondary Outcomes
- Change From Baseline in the FACE-Q Aging Appraisal(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(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(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(Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months))
- Change From Baseline Self-Perception of Age(Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months))
- Investigator's Assessment Using Global Aesthetic Improvement Scale (GAIS)(Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months))
- Subject's Assessment Using Global Aesthetic Improvement Scale (GAIS)(Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months))
- Change From Baseline to End of Study of Periorbital Aesthetic Appearance Questionnaire (PAAQ)(Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months))