Trial Outcomes & Findings for Prospective Evaluation of Facial Cosmetic Procedures (NCT NCT03460158)
NCT ID: NCT03460158
Last Updated: 2024-09-27
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
101 participants
Primary outcome timeframe
2 week post injections
Results posted on
2024-09-27
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
|
Overall Study
STARTED
|
101
|
|
Overall Study
COMPLETED
|
101
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prospective Evaluation of Facial Cosmetic Procedures
Baseline characteristics by cohort
| Measure |
Restylane-L®, Restylane-L® Lyft, and Restylane Silk®
n=101 Participants
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.
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|---|---|
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Age, Continuous
|
53.2 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
101 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · African American/Black
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Caucasian/White
|
92 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
1 Participants
n=5 Participants
|
|
BMI
|
24.4 kg/m^2
n=5 Participants
|
|
Smoking History
Never
|
62 Participants
n=5 Participants
|
|
Smoking History
Current
|
11 Participants
n=5 Participants
|
|
Smoking History
Former
|
27 Participants
n=5 Participants
|
|
Smoking History
Unknown
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 week post injectionsPopulation: Subject who completed the validated patient reported 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.
Outcome measures
| Measure |
Restylane-L®, Restylane-L® Lyft, and Restylane Silk®
n=97 Participants
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.
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|---|---|
|
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
Interval 17.0 to 41.0
|
|
Patient Satisfaction With Validated FACE-Q Aesthetics Survey
Aging Appraisal. (Maximum change 99 and Minimum Change 0).
|
24.0 score on a scale
Interval 8.5 to 41.5
|
|
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
Interval 12.0 to 58.0
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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
Interval 19.0 to 58.0
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|
Patient Satisfaction With Validated FACE-Q Aesthetics Survey
Satisfaction with Lips. (Maximum change 99 and Minimum Change 0).
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23.5 score on a scale
Interval 4.5 to 41.0
|
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Patient Satisfaction With Validated FACE-Q Aesthetics Survey
Satisfaction with Cheekbones. (Maximum change 99 and Minimum Change 0).
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32.0 score on a scale
Interval 17.0 to 53.5
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Patient Satisfaction With Validated FACE-Q Aesthetics Survey
Satisfaction with Cheeks. (Maximum change 99 and Minimum Change 0).
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43.0 score on a scale
Interval 23.0 to 60.0
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Patient Satisfaction With Validated FACE-Q Aesthetics Survey
Satisfaction with Lower Face and Jawline. (Maximum change 99 and Minimum Change 0).
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35.0 score on a scale
Interval 20.0 to 55.0
|
|
Patient Satisfaction With Validated FACE-Q Aesthetics Survey
Psychological Function. (Maximum change 99 and Minimum Change 0).
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13.0 score on a scale
Interval 0.0 to 31.0
|
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Patient Satisfaction With Validated FACE-Q Aesthetics Survey
Social Function. (Maximum change 99 and Minimum Change 0).
|
8.0 score on a scale
Interval 0.0 to 29.0
|
|
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
Interval -29.0 to 0.0
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SECONDARY outcome
Timeframe: upto 90 daysPopulation: Patients who received Hyaluronic acid and patient reported outcomes (PRO)
Linear correlation of relative volumetric change over relative patient satisfaction scale change. These values are reported as correlation coefficients and are unit less.
Outcome measures
| Measure |
Restylane-L®, Restylane-L® Lyft, and Restylane Silk®
n=40 Participants
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.
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|---|---|
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Correlate Patient Satisfaction With Volumetric Measurements
2 weeks post injection
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0.0226 correlation coefficient (unit less)
Interval -0.2779 to 0.3232
|
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Correlate Patient Satisfaction With Volumetric Measurements
4 weeks post injection
|
-0.1796 correlation coefficient (unit less)
Interval -0.4691 to 0.1099
|
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Correlate Patient Satisfaction With Volumetric Measurements
12 weeks post injection
|
-0.3692 correlation coefficient (unit less)
Interval -0.5934 to -0.1451
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SECONDARY outcome
Timeframe: immediately post injection, 2 weeks, 4 weeks, and 12 weeksPopulation: Volume Maintenance of Whole Face
3-dimensional photography to measure volumetric changes in each treatment
Outcome measures
| Measure |
Restylane-L®, Restylane-L® Lyft, and Restylane Silk®
n=99 Participants
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.
|
|---|---|
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Volumetric Changes of Treatment
post injection
|
9.86 cc
Interval 7.37 to 12.6
|
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Volumetric Changes of Treatment
2 weeks
|
8.80 cc
Interval 6.3 to 11.0
|
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Volumetric Changes of Treatment
4 weeks
|
7.63 cc
Interval 5.85 to 10.6
|
|
Volumetric Changes of Treatment
12 weeks
|
5.79 cc
Interval 3.2 to 9.38
|
Adverse Events
Restylane-L®, Restylane-L® Lyft, and Restylane Silk®
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place