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A Study of the Lifting Capacity of Fillers

A Study of the Lifting Capacity of Fillers

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02974985
Enrollment
20
Registered
2016-11-29
Start date
2016-04-30
Completion date
2020-03-31
Last updated
2018-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esthetic & Topographic Shifts From Facial Fillers

Keywords

Facelift, HA Filler, Hyaluronic acid, Facial Rejuvenation, Aging Face, WIZDOM, Midface lift, Midface augmentation

Brief summary

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.

Detailed description

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.

Interventions

DEVICEinjection 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

Sponsors

Galderma R&D
CollaboratorINDUSTRY
Abington Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
40 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* Women ages 40-60 * 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

* History of prior filler injections in the past 12 months. * Pregnancy/planned pregnancy * Allergy to HA products

Design outcomes

Primary

MeasureTime frameDescription
Degree and axes of volume shifts before and after injection of HA fillersimmediately after injectionThe investigators are using Vectra analysis software to analyze volume changes in 3D. dimensions after injection of hyaluronic acid filler.

Secondary

MeasureTime frameDescription
Patient and Observer Satisfaction with Degree of Liftimmediately after injectionChange in global aesthetic assessment measured from baseline.
Measure the capacity of fillers in the midface to change midface position.immediately after injectionH1 and Vectra analytic software: movement of measured points of reference on the face.
Measure the capacity of fillers in the midface to improve relationship between eyelid and cheek.immediately after injectionWIZDOM measurement and WIZDOM -IC measurement
Measurement of MMVSTwo weeks post injections.Medicis Midface Volume Scale
Patient-reported subjective assessment of filler effect and satisfactionTwo weeks post injections.GAIS Scale
Investigator assessment of filler effect.Two weeks post injections.GAIS scale
Measure the capacity of fillers in the midface to change lower face position.immediately after injectionH1 and Vectra analytic software: movement of measured points of reference on the face.

Countries

United States

Contacts

Primary ContactAllan E Wulc, M.D
awulcmd@gmail.com610-828-8880
Backup ContactDeborah Tuccillo, RN
debbie@wcosmeticsurgery.com610-828-8880

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026