Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2016-04-30
2020-03-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Women aged 40-50
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.
injection of Restylane Lyft and Restylane L
Intervention--Injections of volumizing products to the midface, nasolabial fold, and marionette folds in female patients in two different age groups
Women aged 50-60
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.
injection of Restylane Lyft and Restylane L
Intervention--Injections of volumizing products to the midface, nasolabial fold, and marionette folds in female patients in two different age groups
Interventions
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injection of Restylane Lyft and Restylane L
Intervention--Injections of volumizing products to the midface, nasolabial fold, and marionette folds in female patients in two different age groups
Eligibility Criteria
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Inclusion Criteria
* Midface, lower face volume loss and gravitational changes amenable to the administration of HA fillers.
* Filler requirements, based on experienced injector assessment, on the order of 8 syringes.
Exclusion Criteria
* Pregnancy/planned pregnancy
* Allergy to HA products
40 Years
60 Years
FEMALE
Yes
Sponsors
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Galderma R&D
INDUSTRY
Abington Memorial Hospital
OTHER
Responsible Party
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Allan Wulc
Allan E. Wulc, M.D., F.A.C.S
Principal Investigators
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Allan E Wulc, M.D.
Role: PRINCIPAL_INVESTIGATOR
Abington Hospital
Locations
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W Cosmetic Surgery
Plymouth Meeting, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Beer K, Lupo MP. Making the right choices: attaining predictable aesthetic results with dermal fillers. J Drugs Dermatol. 2010 May;9(5):458-65.
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.
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.
Related Links
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Device Company website with FDA prescribing information and warnings
Other Identifiers
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16-023
Identifier Type: -
Identifier Source: org_study_id
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