Esthetic & Topographic Shifts From Facial Fillers Clinical Trial
Official title:
A Study of the Lifting Capacity of Fillers
| NCT number | NCT02974985 |
| Other study ID # | 16-023 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | April 2016 |
| Est. completion date | March 2020 |
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.
| Status | Recruiting |
| Enrollment | 20 |
| Est. completion date | March 2020 |
| Est. primary completion date | September 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 40 Years to 60 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | W Cosmetic Surgery | Plymouth Meeting | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Abington Memorial Hospital | Galderma |
United States,
Beer K, Lupo MP. Making the right choices: attaining predictable aesthetic results with dermal fillers. J Drugs Dermatol. 2010 May;9(5):458-65. Review. — View Citation
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* Note: There are 11 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Degree and axes of volume shifts before and after injection of HA fillers | The investigators are using Vectra analysis software to analyze volume changes in 3D. dimensions after injection of hyaluronic acid filler. | immediately after injection | |
| Secondary | Measurement of MMVS | Medicis Midface Volume Scale | Two weeks post injections. | |
| Secondary | Patient and Observer Satisfaction with Degree of Lift | Change in global aesthetic assessment measured from baseline. | immediately after injection | |
| Secondary | Measure the capacity of fillers in the midface to change midface position. | H1 and Vectra analytic software: movement of measured points of reference on the face. | immediately after injection | |
| Secondary | Measure the capacity of fillers in the midface to improve relationship between eyelid and cheek. | WIZDOM measurement and WIZDOM -IC measurement | immediately after injection | |
| Secondary | Measure the capacity of fillers in the midface to change lower face position. | H1 and Vectra analytic software: movement of measured points of reference on the face. | immediately after injection | |
| Secondary | Patient-reported subjective assessment of filler effect and satisfaction | GAIS Scale | Two weeks post injections. | |
| Secondary | Investigator assessment of filler effect. | GAIS scale | Two weeks post injections. |