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| Name | Class |
|---|---|
| Galderma R&D | INDUSTRY |
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A prospective, trial to quantitatively and qualitatively compare the dermal fillers for the treatment of age related aesthetic changes.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Restylane-L®, Restylane-L® Lyft, and Restylane Silk® | Experimental | Hyaluronic acid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restylane-L® | Drug | Restylane-L® for the indication for mid-to-deep dermal implantation for moderate to severe facial wrinkles and folds, such as nasolabial folds. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 week post injections |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | upto 90 days |
| Volumetric Changes of Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ivona Percec, MD,PhD | University of Pennsylvania Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania Health System | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40178806 | Derived | Davis HD, Mazzaferro D, Habarth-Morales TE, Messa CA 4th, Talwar AA, Desai AA, McAuliffe PB, Broach RB, Serletti JM, Percec I. A Large Prospective Volumetric and Patient-Reported Outcome Analysis of Hyaluronic Acid Facial Fillers. Plast Reconstr Surg. 2025 Oct 1;156(4):550-559. doi: 10.1097/PRS.0000000000012135. Epub 2025 Apr 1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Subject who completed the validated patient reported FACE-Q Aesthetics survey 2 week post-injections | Posted | Median | Inter-Quartile Range | score on a scale | 2 week post injections |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ivona Percec, MD, PhD | University of Pennsylvania | 215-662-7300 | ivona.percec@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 6, 2019 | May 7, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C000634259 | Restylane-L |
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|
| Restylane-L® Lyft | Drug | 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® | Drug | 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. |
|
|
3-dimensional photography to measure volumetric changes in each treatment |
| immediately post injection, 2 weeks, 4 weeks, and 12 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| BMI | Median | Inter-Quartile Range | kg/m^2 |
|
| Smoking History | Count of Participants | Participants |
|
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| 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. | Patients who received Hyaluronic acid and patient reported outcomes (PRO) | Posted | Number | 95% Confidence Interval | correlation coefficient (unit less) | upto 90 days |
|
|
|
|
| Secondary | Volumetric Changes of Treatment | 3-dimensional photography to measure volumetric changes in each treatment | Volume Maintenance of Whole Face | Posted | Median | Inter-Quartile Range | cc | immediately post injection, 2 weeks, 4 weeks, and 12 weeks |
|
|
|
| 0 |
| 101 |
| 0 |
| 101 |
| 0 |
| 101 |
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|
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 injection
| t-test, 2 sided |
| 0.2223 |
| Mean Difference (Final Values) |
| -0.180 |
| Standard Error of the Mean |
| 0.1466 |
| 2-Sided |
| 95 |
| Other |
| 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 injection | t-test, 2 sided | 0.0015 | Mean Difference (Final Values) | -0.369 | Standard Error of the Mean | 0.113 | 2-Sided | 95 | Other |
| Title | Measurements |
|---|---|
|
| 12 weeks |
|