Age-related Volume Deficit in the Mid-face
Conditions
Brief summary
This is a prospective, observational study of the volumizing effect of aesthetic use of Juvéderm VOLUMA® with lidocaine in the mid-face area.
Interventions
DEVICECrosslinked hyaluronic acid gel (Juvéderm VOLUMA®)
All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use.
Sponsors
Allergan Medical
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Desire and willingness for correction of asymmetry or enhancement of his/her mid-face area. * Be willing to undergo treatment for volume loss in the face area * Females and males ≥30 years of age * Be in good health as of the opinion of the Investigator * Sign the Informed Consent Form prior to any study-related procedures being performed * Have established a realistic treatment goal that the Investigator agrees is achievable i.e., have realistic expectations of aesthetic results
Exclusion criteria
* Have extensive tissue damage that could affect the aesthetic outcome * Have a known allergy to any component of VOLUMA® with lidocaine injections * Have an abscess or infection at the time of treatment that in the opinion of the Investigator does not make the subject eligible for the procedure. * Have undergone cosmetic facial \[e.g., face-lift, or other surgeries, which may alter the appearance of the mid-face region (laser, photomodulation intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, or other ablative procedures), tissue augmentation with dermal fillers or fat injections, or meso-therapy\] anywhere in the mid-face region, or Botox® Cosmetic injections in the lower face (below the orbital rim), within the 6 months prior to entry in the study or be planning to undergo any of these procedures at any time during the study. NOTE: Prior treatment with hyaluronic acid (HA) fillers and/or collagen is allowed, provided the treatment was administered more than 6 months prior to study entry * Have ever received semi-permanent fillers or permanent facial implants, e.g., calcium hydroxyapatite, L-polylactic acid, polymethylmethacrylate (PMMA), silicone, expanded polytetrafluoroethylene (ePTFE) anywhere in the lips, or be planning to be implanted with any of these products at any time during the study * Have a history of anaphylaxis, multiple severe allergies, atopy, allergy to lidocaine (or any amide-based anesthetics), HA products, or Streptococcal protein, or be planning to undergo a desensitization therapy during the term of the study * Suffer from an uncontrolled personality disorder (e.g., body dysmorphia, depression) * Have a history of or currently suffer from an autoimmune disease (e.g., Rheumatoid arthritis, Crohn's disease) * Have a history of streptococcal disease (e.g., strep throat or rheumatic fever with or without heart complications) * Have a history of skin cancer * Suffer from Porphyria * Have epilepsy which is not controlled by anti-epilepsy therapy * Current cutaneous inflammatory and/or infectious processes (e.g., acne, herpes, etc.) * Have a history of treatment with interferon therapy (e.g., warfarin) or have taken non-steroidal anti-inflammatory drugs (NSAIDs) (e.g., aspirin, ibuprofen) or other substances known to increase coagulation time (e.g., herbal supplements with garlic or ginko biloba) within 10 days of undergoing study device injection. NOTE: Study device injection may be delayed as necessary to accommodate this 10-day washout period * Be on a concurrent regimen of high doses of lidocaine (more than 400 mg) which may cause acute toxic reactions * Be on a concurrent regimen of other local anesthetics structurally related to amide-type local anesthetics * Have impaired cardiac conduction, severly impaired hepatic function, or severe renal dysfunction * Have a condition or be in a situation that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject Experience Measured by Patient Satisfaction Questionnaire | 3 weeks | Subject satisfaction with treatment, based on a 5-point scale: (1) Delighted, (2) Happy, (3) Neutral, (4) Unhappy, (5) Very Unhappy |
Countries
Belgium, Germany, Netherlands, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Age Group A Subjects 30 to 40 years old
Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use. | 16 |
| Age Group B Subjects 40 to 50 years old
Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use. | 40 |
| Age Group C Subjects over 50 years old
Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use. | 59 |
| Total | 115 |
Baseline characteristics
| Characteristic | Age Group A | Age Group B | Age Group C | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 9 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 40 Participants | 50 Participants | 106 Participants |
| Age, Continuous | 35.7 years STANDARD_DEVIATION 3.3 | 45.2 years STANDARD_DEVIATION 2.8 | 58.3 years STANDARD_DEVIATION 5.8 | 50.6 years STANDARD_DEVIATION 9.7 |
| Region of Enrollment Belgium | 0 participants | 4 participants | 6 participants | 10 participants |
| Region of Enrollment Germany | 8 participants | 25 participants | 33 participants | 66 participants |
| Region of Enrollment Netherlands | 3 participants | 4 participants | 13 participants | 20 participants |
| Region of Enrollment United Kingdom | 5 participants | 7 participants | 7 participants | 19 participants |
| Sex: Female, Male Female | 12 Participants | 34 Participants | 46 Participants | 92 Participants |
| Sex: Female, Male Male | 4 Participants | 6 Participants | 13 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 16 | 1 / 39 | 2 / 57 |
| serious Total, serious adverse events | 0 / 16 | 0 / 39 | 0 / 57 |
Outcome results
Primary
Subject Experience Measured by Patient Satisfaction Questionnaire
Subject satisfaction with treatment, based on a 5-point scale: (1) Delighted, (2) Happy, (3) Neutral, (4) Unhappy, (5) Very Unhappy
Time frame: 3 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Age Group A | Subject Experience Measured by Patient Satisfaction Questionnaire | 1.94 Units on a scale | Standard Deviation 0.68 |
| Age Group B | Subject Experience Measured by Patient Satisfaction Questionnaire | 1.62 Units on a scale | Standard Deviation 0.78 |
| Age Group C | Subject Experience Measured by Patient Satisfaction Questionnaire | 1.51 Units on a scale | Standard Deviation 0.57 |