NCT02974985

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 29, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

July 10, 2018

Status Verified

July 1, 2018

Enrollment Period

2.4 years

First QC Date

November 10, 2016

Last Update Submit

July 7, 2018

Conditions

Esthetic & Topographic Shifts From Facial Fillers

Keywords

FaceliftHA FillerHyaluronic acidFacial RejuvenationAging FaceWIZDOMMidface liftMidface augmentation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (2)

Women aged 40-50

EXPERIMENTAL

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

Women aged 50-60

EXPERIMENTAL

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

Interventions

injection of Restylane Lyft and Restylane LDEVICE

Intervention--Injections of volumizing products to the midface, nasolabial fold, and marionette folds in female patients in two different age groups

Women aged 40-50Women aged 50-60

Eligibility Criteria

Age40 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • History of prior filler injections in the past 12 months.
  • Pregnancy/planned pregnancy
  • Allergy to HA products

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

W Cosmetic Surgery

Plymouth Meeting, Pennsylvania, 19462, United States

RECRUITING

Related Publications (11)

  • Little JW. Volumetric perceptions in midfacial aging with altered priorities for rejuvenation. Plast Reconstr Surg. 2000 Jan;105(1):252-66; discussion 286-9. doi: 10.1097/00006534-200001000-00043.

    PMID: 10626998BACKGROUND

  • Kablik J, Monheit GD, Yu L, Chang G, Gershkovich J. Comparative physical properties of hyaluronic acid dermal fillers. Dermatol Surg. 2009 Feb;35 Suppl 1:302-12. doi: 10.1111/j.1524-4725.2008.01046.x.

    PMID: 19207319BACKGROUND

  • Swift A, Remington K. BeautiPHIcation: a global approach to facial beauty. Clin Plast Surg. 2011 Jul;38(3):347-77, v. doi: 10.1016/j.cps.2011.03.012.

    PMID: 21824535BACKGROUND

  • Ramirez OM. Three-dimensional endoscopic midface enhancement: a personal quest for the ideal cheek rejuvenation. Plast Reconstr Surg. 2002 Jan;109(1):329-40; discussion 341-9. doi: 10.1097/00006534-200201000-00052.

    PMID: 11786834BACKGROUND

  • Surek CC, Beut J, Stephens R, Jelks G, Lamb J. Pertinent anatomy and analysis for midface volumizing procedures. Plast Reconstr Surg. 2015 May;135(5):818e-829e. doi: 10.1097/PRS.0000000000001226.

    PMID: 25919264BACKGROUND

  • Borrell M, Leslie DB, Tezel A. Lift capabilities of hyaluronic acid fillers. J Cosmet Laser Ther. 2011 Feb;13(1):21-7. doi: 10.3109/14764172.2011.552609. Epub 2011 Jan 21.

    PMID: 21254807BACKGROUND

  • Pierre S, Liew S, Bernardin A. Basics of dermal filler rheology. Dermatol Surg. 2015 Apr;41 Suppl 1:S120-6. doi: 10.1097/DSS.0000000000000334.

    PMID: 25828036BACKGROUND

  • Gold M. The science and art of hyaluronic acid dermal filler use in esthetic applications. J Cosmet Dermatol. 2009 Dec;8(4):301-7. doi: 10.1111/j.1473-2165.2009.00464.x.

    PMID: 19958435BACKGROUND

  • Beer K, Lupo MP. Making the right choices: attaining predictable aesthetic results with dermal fillers. J Drugs Dermatol. 2010 May;9(5):458-65.

    PMID: 20480788BACKGROUND

  • 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.

    PMID: 22316188BACKGROUND

  • 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.

    PMID: 29040391BACKGROUND

Related Links

Study Officials

  • Allan E Wulc, M.D.

    Abington Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Allan E Wulc, M.D

CONTACT

610-828-8880awulcmd@gmail.com

Deborah Tuccillo, RN

CONTACT

610-828-8880debbie@wcosmeticsurgery.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Allan E. Wulc, M.D., F.A.C.S

Study Record Dates

First Submitted

November 10, 2016

First Posted

November 29, 2016

Study Start

April 1, 2016

Primary Completion

September 1, 2018

Study Completion

March 1, 2020

Last Updated

July 10, 2018

Record last verified: 2018-07

Locations

US(1)