A Study of the Lifting Capacity of Fillers

July 7, 2018 updated by: Allan Wulc, Abington Memorial Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Device: injection 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
EXPERIMENTAL: 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.
Device: injection 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree and axes of volume shifts before and after injection of HA fillers
Time Frame: immediately after injection
The investigators are using Vectra analysis software to analyze volume changes in 3D. dimensions after injection of hyaluronic acid filler.
immediately after injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of MMVS
Time Frame: Two weeks post injections.
Medicis Midface Volume Scale
Two weeks post injections.
Patient and Observer Satisfaction with Degree of Lift
Time Frame: immediately after injection
Change in global aesthetic assessment measured from baseline.
immediately after injection
Measure the capacity of fillers in the midface to change midface position.
Time Frame: immediately after injection
H1 and Vectra analytic software: movement of measured points of reference on the face.
immediately after injection
Measure the capacity of fillers in the midface to improve relationship between eyelid and cheek.
Time Frame: immediately after injection
WIZDOM measurement and WIZDOM -IC measurement
immediately after injection
Measure the capacity of fillers in the midface to change lower face position.
Time Frame: immediately after injection
H1 and Vectra analytic software: movement of measured points of reference on the face.
immediately after injection
Patient-reported subjective assessment of filler effect and satisfaction
Time Frame: Two weeks post injections.
GAIS Scale
Two weeks post injections.
Investigator assessment of filler effect.
Time Frame: Two weeks post injections.
GAIS scale
Two weeks post injections.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abington Memorial Hospital

Collaborators

Galderma R&D

Investigators

  • Principal Investigator: Allan E Wulc, M.D., Abington Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (ANTICIPATED)

September 1, 2018

Study Completion (ANTICIPATED)

March 1, 2020

Study Registration Dates

First Submitted

November 10, 2016

First Submitted That Met QC Criteria

November 23, 2016

First Posted (ESTIMATE)

November 29, 2016

Study Record Updates

Last Update Posted (ACTUAL)

July 10, 2018

Last Update Submitted That Met QC Criteria

July 7, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

will make protocols and statistics and photos available to all interested including esearch collaborators.

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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