A Study of the Lifting Capacity of Fillers
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Degree and axes of volume shifts before and after injection of HA fillers
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •History of prior filler injections in the past 12 months.
- •Pregnancy/planned pregnancy
- •Allergy to HA products
研究组 & 干预措施
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.
干预措施: injection of Restylane Lyft and Restylane L (Device)
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.
干预措施: injection of Restylane Lyft and Restylane L (Device)
结局指标
主要结局
Degree and axes of volume shifts before and after injection of HA fillers
时间窗: immediately after injection
The investigators are using Vectra analysis software to analyze volume changes in 3D. dimensions after injection of hyaluronic acid filler.
次要结局
- Measurement of MMVS(Two weeks post injections.)
- Patient and Observer Satisfaction with Degree of Lift(immediately after injection)
- Measure the capacity of fillers in the midface to change midface position.(immediately after injection)
- Measure the capacity of fillers in the midface to improve relationship between eyelid and cheek.(immediately after injection)
- Measure the capacity of fillers in the midface to change lower face position.(immediately after injection)
- Patient-reported subjective assessment of filler effect and satisfaction(Two weeks post injections.)
- Investigator assessment of filler effect.(Two weeks post injections.)
研究者
Allan Wulc
Allan E. Wulc, M.D., F.A.C.S
Abington Memorial Hospital