Perioral Rejuvenation, Upper Lip Projection
Conditions
Brief summary
To determine if subjects who receive premaxillary injection demonstrate an increase in nasal tip projection and an associated increase in upper lip projection, and vermillion height.
Interventions
DEVICERestylane® Defyne
hyaluronic acid filler injection
Sponsors
DeNova Research
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* 1\. Subjects Age 21 to 70. 2. Subjects who demonstrate signs of perioral aging or poor upper lip projection.
Exclusion criteria
* 1\. Subjects who plan to undergo peri oral neurotoxin treatments or ablative skin treatments, or have had either of these treatments in the previous 6 months, other injectable filler treatments during the course of the study. 2\. Subjects who are pregnant or nursing. 3. Subjects with a known allergy or sensitivity to any component of the study ingredients. 4\. Any history of rhinoplasty or nasal filler injections. 5. Recent history of upper lip augmentation (surgical and non-surgical) within the last 12 months. 6\. Any history of lip lift or other surgical procedures involving the upper lip. 7\. Any history of chin augmentation (surgical and non-surgical). 8. Any history of orthognathic surgery. 9. Any history of bleeding disorders (iatrogenic or otherwise). 10. Current history of chronic drug or alcohol abuse. 11. Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study product (i.e. immunosuppressive therapy). 12\. Subjects who, in the Investigator's opinion, have a history of poor cooperation, non¬compliance with medical treatment or unreliability.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nasal Tip Projection | Baseline and 2 months | Baseline nasal projection measurements will be documented according to Goode's ratio. The Goode ratio was used as a measurement of tip projection and is defined as the ratio of the nasal height in relation to the nasal length. For each subject's right lateral view photograph, the nasal height was measured as the length of a line drawn from the alar-facial groove to the tip-defining point, and the nasal length was measured as the length of the line drawn from the nasion to the tip-defining point. The nasal height value was then divided by the nasal length value to determine the Goode ratio for a given photograph. The ratio of the line from the alar crease to the nasal tip to the nasion to the nasal tip should be . 55. If it is more than that the nose is overprojected, if it is under that ratio the nose is underprojected. |
| Upper Lip Projection | Baseline and 2 months | baseline upper lip position will recorded by measuring the Z-angle, which is the intersection of the Frankfort horizontal line and the profile line as described by Merrifield. From the straight portrait image, the ratio of the upper lip vermillion height to the lower lip vermillion height will be documented. Upper lip projection was assessed via measurement of the Z angle. On each subject's right lateral view photograph, a profile line was drawn tangential to the pogonion of the chin and to the most anterior point of the upper lip. A second line was drawn along the Frankfort horizontal plane. The resulting angle at which these two lines intersected corresponded to the Z angle. A decrease in the Z angle to a more acute value on post-treatment photographs would correspond to an increase in upper lip projection. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nasal Tip Projection Restylane® Defyne: hyaluronic acid filler injection | 10 |
| Upper Lip Position Restylane® Defyne: hyaluronic acid filler injection | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Upper Lip Position | Total | Nasal Tip Projection |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 20 Participants | 10 Participants |
| Age, Continuous | 41.2 years STANDARD_DEVIATION 0 | 39 years STANDARD_DEVIATION 0 | 36.8 years STANDARD_DEVIATION 0 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 19 Participants | 10 Participants |
| Region of Enrollment United States | 10 participants | 20 participants | 10 participants |
| Sex: Female, Male Female | 10 Participants | 20 Participants | 10 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Nasal Tip Projection
Baseline nasal projection measurements will be documented according to Goode's ratio. The Goode ratio was used as a measurement of tip projection and is defined as the ratio of the nasal height in relation to the nasal length. For each subject's right lateral view photograph, the nasal height was measured as the length of a line drawn from the alar-facial groove to the tip-defining point, and the nasal length was measured as the length of the line drawn from the nasion to the tip-defining point. The nasal height value was then divided by the nasal length value to determine the Goode ratio for a given photograph. The ratio of the line from the alar crease to the nasal tip to the nasion to the nasal tip should be . 55. If it is more than that the nose is overprojected, if it is under that ratio the nose is underprojected.
Time frame: Baseline and 2 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nasal Tip Projection | Nasal Tip Projection | 0.601 ratio | Standard Deviation 0.052 |
Primary
Upper Lip Projection
baseline upper lip position will recorded by measuring the Z-angle, which is the intersection of the Frankfort horizontal line and the profile line as described by Merrifield. From the straight portrait image, the ratio of the upper lip vermillion height to the lower lip vermillion height will be documented. Upper lip projection was assessed via measurement of the Z angle. On each subject's right lateral view photograph, a profile line was drawn tangential to the pogonion of the chin and to the most anterior point of the upper lip. A second line was drawn along the Frankfort horizontal plane. The resulting angle at which these two lines intersected corresponded to the Z angle. A decrease in the Z angle to a more acute value on post-treatment photographs would correspond to an increase in upper lip projection.
Time frame: Baseline and 2 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nasal Tip Projection | Upper Lip Projection | 74.245 degrees | Standard Deviation 10.859 |