A Study of the Lifting Capacity of Fillers

Abington Memorial Hospital

Status: Unknown

Conditions: Esthetic & Topographic Shifts From Facial Fillers

Treatments: Device: injection of Restylane Lyft and Restylane L

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02974985

16-023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 40 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Women aged 40-50

Experimental group

Description:

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.

Treatment:

Device: injection of Restylane Lyft and Restylane L

Women aged 50-60

Experimental group

Description:

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.

Treatment:

Device: injection of Restylane Lyft and Restylane L