Cosmetic Techniques
Conditions
Keywords
facial filler, Retylane, aesthetic improvement, volumizing fillers
Brief summary
A prospective, trial to quantitatively and qualitatively compare the dermal fillers for the treatment of age related aesthetic changes.
Detailed description
Dermal fillers have been approved for the treatment of age related aesthetic changes, including facial volume loss, and attenuation of the static and dynamic rhytid. Despite widespread use of volumizing fillers there is little data quantifying the subjective benefit of these minimally invasive treatments from the patient perspective. Furthermore, there is little data comparing the subjective benefit with true objective volumetric results. Such data will provide much needed information for patient counselling and treatment optimization for patient perceived outcomes. This study is to determine the patient reported outcomes of three different dermal fillers and establish the volumetric changes over 90 days. Screening will be performed during the patient's office visit. Approximately 100 patients will be enrolled. Patients will participate up to 90 days (Day 1, 14 days, 28 days, and 90 days).
Interventions
DRUGRestylane-L®
Restylane-L® for the indication for mid-to-deep dermal implantation for moderate to severe facial wrinkles and folds, such as nasolabial folds.
DRUGRestylane-L® Lyft
Restylane-L® Lyft is for the indication of implantation into the deep dermis to superficial subcutis for the correction of moderate to severe facial folds and wrinkles, such as nasolabial folds and malars (cheek/cheek bone area).
DRUGRestylane Silk®
Restylane Silk® is for the indication for submucosal implantation for lip augmentation and dermal implantation for correction of perioral rhytids in patients over the age of 21.
Sponsors
Galderma R&D
University of Pennsylvania
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Female patients 40 - 65 years of age
Exclusion criteria
* Male patients * Prior surgical facial rejuvenation procedures * Facelift * Neck lift * Blepharoplasty * Facial fat grafting * Prior minimally invasive rejuvenation procedure ≤ 12 months * Known contraindications to devices or drugs used in this study * Facial paralysis * Congenital facial asymmetry * Pregnant women * Patient actively taking blood thinners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction With Validated FACE-Q Aesthetics Survey | 2 week post injections | Absolute Change of the Patient Satisfaction using the validated FACE-Q Aesthetics questionnaire for patient reported assessment of treatment by domain. The absolute change from the patient reported outcome score prior to injection to the patient reported score immediate post-injection. Increase in numeric value indicates the larger patient reported improvement, except for psychosocial distress module where a decrease in numeric value indicates patient improvement. Maximum change 99 and Minimum Change 0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlate Patient Satisfaction With Volumetric Measurements | upto 90 days | Linear correlation of relative volumetric change over relative patient satisfaction scale change. These values are reported as correlation coefficients and are unit less. |
| Volumetric Changes of Treatment | immediately post injection, 2 weeks, 4 weeks, and 12 weeks | 3-dimensional photography to measure volumetric changes in each treatment |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Restylane-L®, Restylane-L® Lyft, and Restylane Silk® Hyaluronic acid
Restylane-L®: Restylane-L® for the indication for mid-to-deep dermal implantation for moderate to severe facial wrinkles and folds, such as nasolabial folds.
Restylane-L® Lyft: Restylane-L® Lyft is for the indication of implantation into the deep dermis to superficial subcutis for the correction of moderate to severe facial folds and wrinkles, such as nasolabial folds and malars (cheek/cheek bone area).
Restylane Silk®: Restylane Silk® is for the indication for submucosal implantation for lip augmentation and dermal implantation for correction of perioral rhytids in patients over the age of 21. | 101 |
| Total | 101 |
Baseline characteristics
| Characteristic | Restylane-L®, Restylane-L® Lyft, and Restylane Silk® |
|---|---|
| Age, Continuous | 53.2 years |
| BMI | 24.4 kg/m^2 |
| Race/Ethnicity, Customized Race African American/Black | 8 Participants |
| Race/Ethnicity, Customized Race Asian | 1 Participants |
| Race/Ethnicity, Customized Race Caucasian/White | 92 Participants |
| Sex: Female, Male Female | 101 Participants |
| Sex: Female, Male Male | 0 Participants |
| Smoking History Current | 11 Participants |
| Smoking History Former | 27 Participants |
| Smoking History Never | 62 Participants |
| Smoking History Unknown | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 101 |
| other Total, other adverse events | 0 / 101 |
| serious Total, serious adverse events | 0 / 101 |
Outcome results
Primary
Patient Satisfaction With Validated FACE-Q Aesthetics Survey
Absolute Change of the Patient Satisfaction using the validated FACE-Q Aesthetics questionnaire for patient reported assessment of treatment by domain. The absolute change from the patient reported outcome score prior to injection to the patient reported score immediate post-injection. Increase in numeric value indicates the larger patient reported improvement, except for psychosocial distress module where a decrease in numeric value indicates patient improvement. Maximum change 99 and Minimum Change 0.
Time frame: 2 week post injections
Population: Subject who completed the validated patient reported FACE-Q Aesthetics survey 2 week post-injections
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Restylane-L®, Restylane-L® Lyft, and Restylane Silk® | Patient Satisfaction With Validated FACE-Q Aesthetics Survey | Satisfaction with Facial Appearance. (Maximum change 99 and Minimum Change 0). | 28.0 score on a scale |
| Restylane-L®, Restylane-L® Lyft, and Restylane Silk® | Patient Satisfaction With Validated FACE-Q Aesthetics Survey | Aging Appraisal. (Maximum change 99 and Minimum Change 0). | 24.0 score on a scale |
| Restylane-L®, Restylane-L® Lyft, and Restylane Silk® | Patient Satisfaction With Validated FACE-Q Aesthetics Survey | Appraisal of Lines: Nasolabial Folds. (Maximum change 99 and Minimum Change 0). | 36.0 score on a scale |
| Restylane-L®, Restylane-L® Lyft, and Restylane Silk® | Patient Satisfaction With Validated FACE-Q Aesthetics Survey | Satisfaction with Cheeks. (Maximum change 99 and Minimum Change 0). | 43.0 score on a scale |
| Restylane-L®, Restylane-L® Lyft, and Restylane Silk® | Patient Satisfaction With Validated FACE-Q Aesthetics Survey | Appraisal of Lines: Marionette Lines. (Maximum change 99 and Minimum Change 0). | 36.0 score on a scale |
| Restylane-L®, Restylane-L® Lyft, and Restylane Silk® | Patient Satisfaction With Validated FACE-Q Aesthetics Survey | Satisfaction with Lips. (Maximum change 99 and Minimum Change 0). | 23.5 score on a scale |
| Restylane-L®, Restylane-L® Lyft, and Restylane Silk® | Patient Satisfaction With Validated FACE-Q Aesthetics Survey | Satisfaction with Cheekbones. (Maximum change 99 and Minimum Change 0). | 32.0 score on a scale |
| Restylane-L®, Restylane-L® Lyft, and Restylane Silk® | Patient Satisfaction With Validated FACE-Q Aesthetics Survey | Satisfaction with Lower Face and Jawline. (Maximum change 99 and Minimum Change 0). | 35.0 score on a scale |
| Restylane-L®, Restylane-L® Lyft, and Restylane Silk® | Patient Satisfaction With Validated FACE-Q Aesthetics Survey | Psychological Function. (Maximum change 99 and Minimum Change 0). | 13.0 score on a scale |
| Restylane-L®, Restylane-L® Lyft, and Restylane Silk® | Patient Satisfaction With Validated FACE-Q Aesthetics Survey | Social Function. (Maximum change 99 and Minimum Change 0). | 8.0 score on a scale |
| Restylane-L®, Restylane-L® Lyft, and Restylane Silk® | Patient Satisfaction With Validated FACE-Q Aesthetics Survey | Appearance-Related Psychosocial Distress. (Maximum change 99 and Minimum Change 0). | -12.0 score on a scale |
Secondary
Correlate Patient Satisfaction With Volumetric Measurements
Linear correlation of relative volumetric change over relative patient satisfaction scale change. These values are reported as correlation coefficients and are unit less.
Time frame: upto 90 days
Population: Patients who received Hyaluronic acid and patient reported outcomes (PRO)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Restylane-L®, Restylane-L® Lyft, and Restylane Silk® | Correlate Patient Satisfaction With Volumetric Measurements | 2 weeks post injection | 0.0226 correlation coefficient (unit less) |
| Restylane-L®, Restylane-L® Lyft, and Restylane Silk® | Correlate Patient Satisfaction With Volumetric Measurements | 4 weeks post injection | -0.1796 correlation coefficient (unit less) |
| Restylane-L®, Restylane-L® Lyft, and Restylane Silk® | Correlate Patient Satisfaction With Volumetric Measurements | 12 weeks post injection | -0.3692 correlation coefficient (unit less) |
Comparison: Two-sample t test with equal variances the null hypothesis is the relative change in volume and relative change in patient reported outcomes will be the same at 2 weeks post injectionp-value: 0.8822t-test, 2 sided
Comparison: Two-sample t test with equal variances the null hypothesis is the change in volume and change in patient reported outcomes will be the same at 4 weeks post injectionp-value: 0.2223t-test, 2 sided
Comparison: Two-sample t test with equal variances the null hypothesis is the change in volume and change in patient reported outcomes will be the same at 12 weeks post injectionp-value: 0.0015t-test, 2 sided
Secondary
Volumetric Changes of Treatment
3-dimensional photography to measure volumetric changes in each treatment
Time frame: immediately post injection, 2 weeks, 4 weeks, and 12 weeks
Population: Volume Maintenance of Whole Face
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Restylane-L®, Restylane-L® Lyft, and Restylane Silk® | Volumetric Changes of Treatment | 4 weeks | 7.63 cc |
| Restylane-L®, Restylane-L® Lyft, and Restylane Silk® | Volumetric Changes of Treatment | 12 weeks | 5.79 cc |
| Restylane-L®, Restylane-L® Lyft, and Restylane Silk® | Volumetric Changes of Treatment | post injection | 9.86 cc |
| Restylane-L®, Restylane-L® Lyft, and Restylane Silk® | Volumetric Changes of Treatment | 2 weeks | 8.80 cc |