Esthetic & Topographic Shifts From Facial FillersNCT02974985
A Study of the Lifting Capacity of Fillers
A study testing injection of Restylane Lyft and Restylane L in people with Esthetic & Topographic Shifts From Facial Fillers, run by Abington Memorial Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Esthetic & Topographic Shifts From Facial Fillers
- What is being tested?
- injection of Restylane Lyft and Restylane L
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- History of prior filler injections in the past 12 months.
- Pregnancy/planned pregnancy
- Allergy to HA products
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
W Cosmetic Surgery
Plymouth Meeting, Pennsylvania, 19462
Allan E Wulc, M.D., 610-828-8880, awulcmd@gmail.com
Deborah Tuccillo, RN, 610-828-8880, debbie@wcosmeticsurgery.com
About this study
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.
Read more
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.
Read the 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.
- Being tested
- injection of Restylane Lyft and Restylane L
- Keywords
- Facelift, HA Filler, Hyaluronic acid, Facial Rejuvenation, Aging Face, WIZDOM, Midface lift, Midface augmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: injection of Restylane Lyft and Restylane L |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: immediately after injection
Secondary outcomes (7)
Measurement of MMVS
Medicis Midface Volume Scale
Measured: Two weeks post injections.
Patient and Observer Satisfaction with Degree of Lift
Change in global aesthetic assessment measured from baseline.
Measured: immediately after injection
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.
Measured: immediately after injection
Measure the capacity of fillers in the midface to improve relationship between eyelid and cheek.
WIZDOM measurement and WIZDOM -IC measurement
Measured: immediately after injection
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.
Measured: immediately after injection
Patient-reported subjective assessment of filler effect and satisfaction
GAIS Scale
Measured: Two weeks post injections.
Investigator assessment of filler effect.
GAIS scale
Measured: Two weeks post injections.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startApr 2016
- Primary completionSep 2018 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Esthetic & Topographic Shifts From Facial FillersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abington Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Galderma R&D
- Responsible party
- Principal investigator, Allan Wulc, Abington Memorial Hospital
- Investigators
- Allan E Wulc, M.D., Principal investigator, Abington Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02974985
- Sponsor's protocol ID
- 16-023
- Status last verified
- Jul 2018
- First submitted
- 10 Nov 2016
- Last updated
- 10 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: will make protocols and statistics and photos available to all interested including esearch collaborators.
Publications
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.
PubMed 10626998Kablik 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.
PubMed 19207319Swift 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.
PubMed 21824535Ramirez 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.
PubMed 11786834Surek 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.
PubMed 25919264Borrell 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.
PubMed 21254807Pierre S, Liew S, Bernardin A. Basics of dermal filler rheology. Dermatol Surg. 2015 Apr;41 Suppl 1:S120-6. doi: 10.1097/DSS.0000000000000334.
PubMed 25828036Gold 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.
PubMed 19958435Beer K, Lupo MP. Making the right choices: attaining predictable aesthetic results with dermal fillers. J Drugs Dermatol. 2010 May;9(5):458-65.
PubMed 20480788Carruthers 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.
PubMed 22316188Linkov 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.
PubMed 29040391
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Lifting Capacity of Fillers
- ClinicalTrials.gov ID
- NCT02974985
- Acronym / sponsor ID
- 16-023
- Keywords
- Facelift, HA Filler, Hyaluronic acid, Facial Rejuvenation, Aging Face, WIZDOM, Midface lift, Midface augmentation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Abington Memorial HospitalUniversity, hospital or other
- Collaborators
- Galderma R&D
- Study start
- Apr 2016
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 29 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women aged 40-50 | Experimental | Device: injection of Restylane Lyft and Restylane LIntervention--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. |
| Women aged 50-60 | Experimental | Device: injection of Restylane Lyft and Restylane LIntervention--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. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- History of prior filler injections in the past 12 months.
- Pregnancy/planned pregnancy
- Allergy to HA products
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| injection of Restylane Lyft and Restylane LIntervention--Injections of volumizing products to the midface, nasolabial fold, and marionette folds in female patients in two different age groups | Device | Women aged 40-50, Women aged 50-60 |
Primary outcome
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.
7 secondary outcomes
Measurement of MMVS
Time frame: Two weeks post injections.
Patient and Observer Satisfaction with Degree of Lift
Time frame: immediately after injection
Measure the capacity of fillers in the midface to change midface position.
Time frame: immediately after injection
Measure the capacity of fillers in the midface to improve relationship between eyelid and cheek.
Time frame: immediately after injection
Measure the capacity of fillers in the midface to change lower face position.
Time frame: immediately after injection
Patient-reported subjective assessment of filler effect and satisfaction
Time frame: Two weeks post injections.
Investigator assessment of filler effect.
Time frame: Two weeks post injections.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2018.
- Background: PubMed 10626998Little 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.
- Background: PubMed 19207319Kablik 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.
- Background: PubMed 21824535Swift 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.
- Background: PubMed 11786834Ramirez 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.
- Background: PubMed 25919264Surek 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.
- Background: PubMed 21254807Borrell 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.
- Background: PubMed 25828036Pierre S, Liew S, Bernardin A. Basics of dermal filler rheology. Dermatol Surg. 2015 Apr;41 Suppl 1:S120-6. doi: 10.1097/DSS.0000000000000334.
- Background: PubMed 19958435Gold 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.
- Background: PubMed 20480788Beer K, Lupo MP. Making the right choices: attaining predictable aesthetic results with dermal fillers. J Drugs Dermatol. 2010 May;9(5):458-65.
- Background: PubMed 22316188Carruthers 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.
- Background: PubMed 29040391Linkov 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.
- Device Company website with FDA prescribing information and warningsLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. will make protocols and statistics and photos available to all interested including esearch collaborators.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allan E Wulc, M.D. principal investigator
Abington Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing injection of Restylane Lyft and Restylane L in people with Esthetic & Topographic Shifts From Facial Fillers, run by Abington Memorial Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Allan E Wulc, M.D (610-828-8880, awulcmd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree and axes of volume shifts before and after injection of HA fillers (time frame: immediately after injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02974985, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2018.