Volume Deficiency of the Midface
Conditions
Brief summary
The purpose of the study is to investigate the degree of improvement in appearance after treatment with different hyaluronic acid (HA) fillers. Product selection is based on Investigator assessment of participant tissue coverage and main treatment goal (volumizing, lifting or contouring).
Interventions
DEVICERestylane Volyme
Hyaluronic based filler
DEVICERestylane Defyne
Hyaluronic based filler
DEVICERestylane Lyft Lidocaine
Hyaluronic based filler
Sponsors
Galderma R&D
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Male/Female 25 to 55 years old that needs lifting, contouring or volumization of the midface * Signed and dated informed consent
Exclusion criteria
* Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel and lidocain * Previous use of any permanent or semi-permanent facial tissue augmentation therapy or contouring with, lifting threads, permanent implants, or autologous fat in the treatment area * Previous use of any HA or collagen based facial tissue augmentation therapy in the facial area, any previous use of neurotoxin or any previous facial surgery * Any medical condition that in the opinion of the Investigator would make the participant unsuitable for inclusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Aesthetic Improvement of Midface | 8 weeks | A blinded evaluator assesses the improvement compared to baseline (pre-treatment) using a 5-graded scale; Worse, No change, Improved, Much improved or Very much improved. Aesthetic improvement of midface is defined as those participants assessed as Improved, Much improved or Very much improved. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Improved Midface Volume | 8 weeks | A blinded evaluator assessed the fullness of the midface by using a 4-graded scale where 1= fairly full and 4= substantial loss of fullness. Improved midface volume was defined as at least a 1-grade decrease from baseline. |
| Percentage of Participants Assessed as Having Natural Treatment Results | 8 weeks | Blinded evaluator assessed participants by answering Strongly agree/Agree/Neither agree nor disagree/Disagree/Strongly disagree to the question Are the subject's treatment results natural looking?. Having natural treatment results is defined as being assessed with answers Strongly agree or Agree. |
Countries
Germany, Italy, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Restylane Volyme According to the treatment algorithm, Restylane Volyme was chosen for participants whose primary need for treatment was volume deficiency.
Restylane Volyme: Hyaluronic based filler | 31 |
| Restylane Defyne According to the treatment algorithm, Restylane Defyne was chosen for participants with thin tissue coverage and whose primary need for treatment was lifting or contouring.
Restylane Defyne: Hyaluronic based filler | 25 |
| Restylane Lyft Lidocaine According to the treatment algorithm, Restylane Lyft Lidocaine was chosen for participants with thick tissue coverage and whose primary need for treatment was lifting or contouring.
Restylane Lyft Lidocaine: Hyaluronic based filler | 34 |
| Total | 90 |
Baseline characteristics
| Characteristic | Restylane Defyne | Restylane Lyft Lidocaine | Restylane Volyme | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 34 Participants | 31 Participants | 90 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 24 Participants | 34 Participants | 31 Participants | 89 Participants |
| Region of Enrollment Germany | 8 participants | 11 participants | 11 participants | 30 participants |
| Region of Enrollment Italy | 7 participants | 13 participants | 10 participants | 30 participants |
| Region of Enrollment United Kingdom | 10 participants | 10 participants | 10 participants | 30 participants |
| Sex: Female, Male Female | 19 Participants | 29 Participants | 26 Participants | 74 Participants |
| Sex: Female, Male Male | 6 Participants | 5 Participants | 5 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 25 | 0 / 34 |
| other Total, other adverse events | 3 / 31 | 0 / 25 | 0 / 34 |
| serious Total, serious adverse events | 0 / 31 | 0 / 25 | 0 / 34 |
Outcome results
Primary
Percentage of Participants With Aesthetic Improvement of Midface
A blinded evaluator assesses the improvement compared to baseline (pre-treatment) using a 5-graded scale; Worse, No change, Improved, Much improved or Very much improved. Aesthetic improvement of midface is defined as those participants assessed as Improved, Much improved or Very much improved.
Time frame: 8 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Restylane Volyme | Percentage of Participants With Aesthetic Improvement of Midface | 96.8 percentage of participants |
| Restylane Defyne | Percentage of Participants With Aesthetic Improvement of Midface | 100 percentage of participants |
| Restylane Lyft Lidocaine | Percentage of Participants With Aesthetic Improvement of Midface | 97.1 percentage of participants |
Secondary
Percentage of Participants Assessed as Having Natural Treatment Results
Blinded evaluator assessed participants by answering Strongly agree/Agree/Neither agree nor disagree/Disagree/Strongly disagree to the question Are the subject's treatment results natural looking?. Having natural treatment results is defined as being assessed with answers Strongly agree or Agree.
Time frame: 8 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Restylane Volyme | Percentage of Participants Assessed as Having Natural Treatment Results | 93.5 percentage of participants |
| Restylane Defyne | Percentage of Participants Assessed as Having Natural Treatment Results | 100 percentage of participants |
| Restylane Lyft Lidocaine | Percentage of Participants Assessed as Having Natural Treatment Results | 93.9 percentage of participants |
Secondary
Percentage of Participants With Improved Midface Volume
A blinded evaluator assessed the fullness of the midface by using a 4-graded scale where 1= fairly full and 4= substantial loss of fullness. Improved midface volume was defined as at least a 1-grade decrease from baseline.
Time frame: 8 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Restylane Volyme | Percentage of Participants With Improved Midface Volume | 90.3 percentage of participants |
| Restylane Defyne | Percentage of Participants With Improved Midface Volume | 87.5 percentage of participants |
| Restylane Lyft Lidocaine | Percentage of Participants With Improved Midface Volume | 79.4 percentage of participants |