Clinical trial NCT02974985: A Study of the Lifting Capacity of Fillers
Official title: A Study of the Lifting Capacity of Fillers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esthetic & Topographic Shifts From Facial Fillers
Keywords: Facelift
HA Filler
Hyaluronic acid
Facial Rejuvenation
Aging Face
WIZDOM
Midface lift
Midface augmentation
Lead sponsor: Abington Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Galderma R&D
First posted: 2016-11-29
Enrollment: 20
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Degree and axes of volume shifts before and after injection of HA fillers
timeFrame: immediately after injection
Secondary outcomes:
measure: Measurement of MMVS
timeFrame: Two weeks post injections.
measure: Patient and Observer Satisfaction with Degree of Lift
timeFrame: immediately after injection
measure: Measure the capacity of fillers in the midface to change midface position.
timeFrame: immediately after injection
measure: Measure the capacity of fillers in the midface to improve relationship between eyelid and cheek.
timeFrame: immediately after injection
measure: Measure the capacity of fillers in the midface to change lower face position.
timeFrame: immediately after injection
measure: Patient-reported subjective assessment of filler effect and satisfaction
timeFrame: Two weeks post injections.
measure: Investigator assessment of filler effect.
timeFrame: Two weeks post injections.
Other outcomes:
Locations:
city: Plymouth Meeting
country: United States
facility: W Cosmetic Surgery
state: Pennsylvania
Study officials:
affiliation: Abington Hospital
name: Allan E Wulc, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.