Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Galderma R&D | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Hyaluronic acid (HA) fillers are tested in-vitro to measure their lifting capacity, viscosity, cohesivity, and rheologic properties, and their lifting capacity has been tested in animal models. To date, there are no studies that measure the lifting capacity of fillers in an in-vivo human model.
The intention is to study the lifting capacity of fillers in a group of patients by comparing pre and post-procedure two and three-dimensional photographs using analytic software. Specifically, the PI is interested in determining the amount of tissue elevation created by injecting HAs Restylane-Lyft®, and Restylane-L® (Galderma Laboratories, L.P., Fort Worth, TX) to the midface and to the lower face, both in the anterior-posterior direction and in the vertical direction by using analytic software.
The research group has identified a reliable and reproducible quantitative assessment of midfacial position called WIZDOM (Width of the InterZygomatic Distance Of the Midface) to quantitatively evaluate the midface. It can be used as an objective tool to assess midfacial rejuvenation, whether with fat, fillers, or midface or facelift surgery. The Distance from WIZDOM to inner canthus, the WIZDOM -IC measurement increases with aging as the face deflates and descends, and, in the practice, is also a means of assessing the midface in youth and in aging. The PI's findings have been published in the Aesthetic Surgery Journal. The practice will also attempt to utilize this metric as a measure of midface aesthetic lifting capacity.
The practice will also employ 3 D photography and analytic software to determine degree of lift in mm in the y and z axis. (vertical and AP increase in dimension) pre and post- injection. (Vectra, Canfield, Fairfield, NJ)
We will recruit patients from a population of subjects that generally would receive fillers to improve changes associated with facial volume loss and divide them in to two groups based on chronologic age.
All fillers will be injected in locations where the FDA has approved it for on-label indications (the cheek, subcutaneously and supraperiosteally, the dermis and subdermis for the correction of wrinkles and folds such as the nasolabial fold) and placed as usual and customary using techniques as practiced by the authors and as are accepted widely.
Additional steps prior to injection for this study are temporary sterile magic marker markings markers on the face and detailed photography, both 2D and 3D, that will be taken before, during, and after injection, and the segmentation of injections such that the midface will be injected prior to and separately from the lower face.
Three dimensional data will be analyzed using Vectra analytic software, and 2-D photographs will be analyzed by measuring improvements in WIZDOM (width of the interzygomatic distance of the midface) and its distance to the inner canthus.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women aged 40-50 | Experimental | Intervention--Injections of volumizing products Restylane L and Restylane Lyft with endpoint " a dramatic result is seen that is agreed upon by both subject and injector". The number of injections will be determined (and quantified) by both the patient and the PI to achieve this endpoint. |
|
| Women aged 50-60 | Experimental | Intervention--Injections of volumizing products Restylane L and Restylane Lyft with endpoint " a dramatic result is seen that is agreed upon by both subject and injector". The number of injections will be determined (and quantified) by both the patient and the PI to achieve this endpoint. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| injection of Restylane Lyft and Restylane L | Device | Intervention--Injections of volumizing products to the midface, nasolabial fold, and marionette folds in female patients in two different age groups |
| Measure | Description | Time Frame |
|---|---|---|
| Degree and axes of volume shifts before and after injection of HA fillers | The investigators are using Vectra analysis software to analyze volume changes in 3D. dimensions after injection of hyaluronic acid filler. | immediately after injection |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of MMVS | Medicis Midface Volume Scale | Two weeks post injections. |
| Patient and Observer Satisfaction with Degree of Lift | Change in global aesthetic assessment measured from baseline. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Allan E Wulc, M.D | Contact | 610-828-8880 | awulcmd@gmail.com | |
| Deborah Tuccillo, RN | Contact | 610-828-8880 | debbie@wcosmeticsurgery.com |
| Name | Affiliation | Role |
|---|---|---|
| Allan E Wulc, M.D. | Abington Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| W Cosmetic Surgery | Recruiting | Plymouth Meeting | Pennsylvania | 19462 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10626998 | Background | Little JW. Volumetric perceptions in midfacial aging with altered priorities for rejuvenation. Plast Reconstr Surg. 2000 Jan;105(1):252-66; discussion 286-9. doi: 10.1097/00006534-200001000-00043. | |
| 19207319 | Background | Kablik J, Monheit GD, Yu L, Chang G, Gershkovich J. Comparative physical properties of hyaluronic acid dermal fillers. Dermatol Surg. 2009 Feb;35 Suppl 1:302-12. doi: 10.1111/j.1524-4725.2008.01046.x. |
| Label | URL |
|---|---|
| Device Company website with FDA prescribing information and warnings | View source |
Not provided
will make protocols and statistics and photos available to all interested including esearch collaborators.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| immediately after injection |
| Measure the capacity of fillers in the midface to change midface position. | H1 and Vectra analytic software: movement of measured points of reference on the face. | immediately after injection |
| Measure the capacity of fillers in the midface to improve relationship between eyelid and cheek. | WIZDOM measurement and WIZDOM -IC measurement | immediately after injection |
| Measure the capacity of fillers in the midface to change lower face position. | H1 and Vectra analytic software: movement of measured points of reference on the face. | immediately after injection |
| Patient-reported subjective assessment of filler effect and satisfaction | GAIS Scale | Two weeks post injections. |
| Investigator assessment of filler effect. | GAIS scale | Two weeks post injections. |
| 21824535 | Background | Swift A, Remington K. BeautiPHIcation: a global approach to facial beauty. Clin Plast Surg. 2011 Jul;38(3):347-77, v. doi: 10.1016/j.cps.2011.03.012. |
| 11786834 | Background | Ramirez OM. Three-dimensional endoscopic midface enhancement: a personal quest for the ideal cheek rejuvenation. Plast Reconstr Surg. 2002 Jan;109(1):329-40; discussion 341-9. doi: 10.1097/00006534-200201000-00052. |
| 25919264 | Background | Surek CC, Beut J, Stephens R, Jelks G, Lamb J. Pertinent anatomy and analysis for midface volumizing procedures. Plast Reconstr Surg. 2015 May;135(5):818e-829e. doi: 10.1097/PRS.0000000000001226. |
| 21254807 | Background | Borrell M, Leslie DB, Tezel A. Lift capabilities of hyaluronic acid fillers. J Cosmet Laser Ther. 2011 Feb;13(1):21-7. doi: 10.3109/14764172.2011.552609. Epub 2011 Jan 21. |
| 25828036 | Background | Pierre S, Liew S, Bernardin A. Basics of dermal filler rheology. Dermatol Surg. 2015 Apr;41 Suppl 1:S120-6. doi: 10.1097/DSS.0000000000000334. |
| 19958435 | Background | Gold M. The science and art of hyaluronic acid dermal filler use in esthetic applications. J Cosmet Dermatol. 2009 Dec;8(4):301-7. doi: 10.1111/j.1473-2165.2009.00464.x. |
| 20480788 | Background | Beer K, Lupo MP. Making the right choices: attaining predictable aesthetic results with dermal fillers. J Drugs Dermatol. 2010 May;9(5):458-65. |
| 22316188 | Background | Carruthers J, Flynn TC, Geister TL, Gortelmeyer R, Hardas B, Himmrich S, Jones D, Kerscher M, de Maio M, Mohrmann C, Narins RS, Pooth R, Rzany B, Sattler G, Buchner L, Benter U, Breitscheidel L, Carruthers A. Validated assessment scales for the mid face. Dermatol Surg. 2012 Feb;38(2 Spec No.):320-32. doi: 10.1111/j.1524-4725.2011.02251.x. |
| 29040391 | Background | Linkov G, Mally P, Czyz CN, Wulc AE. Quantification of the Aesthetically Desirable Female Midface Position. Aesthet Surg J. 2018 Feb 15;38(3):231-240. doi: 10.1093/asj/sjx122. |