Facial Volume LossPhase 4NCT03381040
Midfacial Product Selection
A Phase 4 study testing Restylane Lyft and Restylane Volyme in people with Facial Volume Loss, run by Erevna Innovations Inc. at 1 site in Canada.
Trial summary
This study seeks to determine whether patients pursuing injectable treatments for facial volume loss and/or contour deficiency can be separated into strata based on characteristics such as skin envelope and subcutaneous tissue quantity in the zygomatic, submalar and anteromedial cheek regions in order to guide the… Read more about this study
- Who is it for?
- Ages 30 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Facial Volume Loss
- What is being tested?
- Restylane Lyft and Restylane Volyme
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 5 Dec 2017to 8 Jan 2019
- Phase
- Phase 4
- 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 30 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At the time of consent, women between the ages of 30 and 75 years old;
- Patients with established mid-face/cheek hollowing;
- Patients with a MMVS score of 2 or 3 at baseline;
- Accepted the obligation not to receive any other facial procedures through the 4-month follow-up;
- Understood and accepted the obligation and would be logistically able to appear for all scheduled follow-up visits;
- No previous facial fillers for a period of 12 months prior to this study;
- No previous facial fillers in the mid-face for 18 months prior to this study;
- Capable of providing informed consent.
Who cannot join
- Current Pregnancy or lactation [sexually active women of childbearing age must agree to use medically acceptable methods of contraception for the duration of this study (e.g., oral contraceptives, condoms, intrauterine device, shot/injection, patch)].;
- Hypersensitivity to Restylane products, hyaluronic acid filler or amide local anesthetics;
- Patients presenting with porphyria;
- Inability to comply with follow-up and abstain from facial injections during the study period;
- Heavy smokers, classified as smoking more than 12 cigarettes per day;
- History of severe or multiple allergies manifested by anaphylaxis;
Show all 20Show fewer
- Previous tissue revitalization therapy in the treatment area within 6 months before treatment with laser or light, mesotherapy, radiofrequency, ultrasound, cryotherapy, chemical peeling, or dermabrasion;
- Previous surgery including aesthetic facial surgical therapy or liposuction, piercing, or tattoos in the treatment area;
- History or presence of any disease or lesion near or at the treatment area, including inflammation, active or chronic infection, including in the mouth, dentals, head and neck region;
- Facial psoriasis, eczema, acne, rosacea, perioral dermatitis and herpes zoster;
- Scars or deformities;
- Cancer or precancer, e.g. actinic keratosis;
- History of radiation therapy to the treatment area;
- History of bleeding disorders or treatment with thrombolytics, anticoagulants, or inhibitors of platelet aggregation (e.g. Aspirin or other non-steroid anti-inflammatory drugs [NSAIDs]), within 2 weeks before treatment;
- Patients using immunosuppressants;
- Patients with a tendency to form hypertrophic scars or any other healing disorders;
- Patients with known hypersensitivity to lidocaine or agents structurally related to amide type local anaesthetics (e.g., certain anti-arrhythmics);
- Patients administered dental block or topical administration of lidocaine;
- Patients with epilepsy, impaired cardiac conduction, severely impaired hepatic function or severe renal dysfunction.
- Skin thickness between 1.2mm and 1.49mm (as determined by ultrasound).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictive Algorithm for Product Selection in the Management of Mid Facial Volume Correction: Part I - A Pilot Validation of Patient Strata
This study seeks to determine whether patients pursuing injectable treatments for facial volume loss and/or contour deficiency can be separated into strata based on characteristics such as skin envelope and subcutaneous tissue quantity in the zygomatic, submalar and anteromedial cheek regions in order to guide the clinician in making the ideal product choice (i.e., Restylane Volyme vs Lyft)?
Read the detailed description
With age, loss of facial fat and hollowing of the cheeks can result in a "sinking" appearance in the mid-face. Augmentation and contouring of the area can be corrected using dermal fillers such as Restylane.
Currently, product choice and amount of volume used for injectable procedures varies between physicians as there is no standard for treatment. Individual assessment based on the attending physician's preference and experience determines final product selection and technique. An algorithm is needed to standardize best practices between physicians and clinics and to better regulate the use of dermal fillers in facial plastic surgery.
Therefore, the purpose of this study is to is to develop an algorithm to decide on which product (i.e., Restylane Volyme or Lyft) to use in the cheek area based on subject characteristics such as age, skin quality, subcutaneous fat quantity and positioning, and bony structure.
- Conditions
- Facial Volume Loss
- Being tested
- Restylane Lyft, Restylane Volyme
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restylane LyftDevice
Restylane® Lyft is a sterile gel of hyaluronic acid with lidocaine generated by Streptococcus species of bacteria, chemically cross-linked with BDDE (the cross linker), stabilized and suspended in phosphate buffered saline at pH=7 and concentration of 20 mg/mL. Lyft is intended to be used for facial tissue augmentation. It is recommended that the product be used for shaping the contours of the face and the correction of folds using the co-packed needles. Given the very high lift capacity of Lyft, it is often used when the skin envelope is normal or thicker than normal, as the contours of the product may be palpable in the presence of thin skin.
Restylane VolymeDevice
Restylane® Volyme is a sterile, biodegradable, viscoelastic, non-pyrogenic, clear, colorless, and homogeneous soft hyaluronic acid gel with a high lifting capacity. Volyme is intended for injection into the supraperiostic zone or subcutis to augment the volume of the cheeks.
Given Volyme's viscoelastic and lifting capacities, it is best used when there is significant loss of volume and a thin skin envelope.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Poor structural support/volume (atrophy of soft tissues, leading to loss of projection) with adequate skin envelope (normal or thick skin). Treated with Restylane Lyft. Receives: Device: Restylane Lyft |
| Group B | Active comparator | Poor structural support/volume (atrophy of soft tissues, leading to loss of projection) with poor skin envelope (thin skin). Treated with Restylane Volyme. Receives: Device: Restylane Volyme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of two Restylane products to treat mid-face/cheek deformities.
Investigators will evaluate whether a difference in physician assessed efficacy as per the standardized photos between two Restylane products at 16 weeks (visit 5) in comparison to baseline (visit 1) using the GAIS scale.
Measured: Baseline and Week 16.
Secondary outcomes (5)
Standardized Imagery for the Improvement of Mid-face Hollowing
Investigators will evaluate whether an aesthetic change in mid-face contour is observed at visit 3 (4 weeks), and visit 4 (8 weeks) compared to Baseline. The change in mid-face shape will be assessed using the standardized photographs.
Measured: Baseline to week 8
Patient satisfaction questionnaire
Patients will rate their overall satisfaction with treatment results using the patient satisfaction questionnaire at visits 2, 3, 4 and 5. The questionnaire is a 5-point scale comprising 'extremely satisfied', 'satisfied', 'slightly satisfied', 'dissatisfied', and 'extremely satisfied'.
Measured: Baseline to 16 weeks
Global aesthetic improvement scale
Physicians will rate the overall improvement since injection using the Global Aesthetic Improvement Scale at visits 2, 3, 4 and 5. The scale is a 5-point scale comprising 'very much improved', 'much improved', 'improved', 'no change', and 'worse'.
Measured: Baseline to 16 weeks
Medicis Mid-face Volume Scale
At visits 2, 3, 4 and 5, a blinded reviewer will rate each patient's hemiface using the MMVS. The MMVS is a four-point scale that measures the amount of mid-face volume loss comprising of "fairly full", "mild loss", "moderate loss" and "substantial loss". MMVS response rate, defined as the percentage of subjects with at least a 1-grade improvement in MMVS from Baseline up to Week 16 after treatment, will be used in the analyses.
Measured: Baseline to 16 weeks
Standardized Ultrasonography Images
Ultrasound images will be taken before and after injections at the Baseline visit, and all subsequent follow up visits. At Visit 1, the images will be used to determine skin thickness and ascertain the site (e.g., dermis, subcutaneous region) of filler injected into the soft tissue of the face. At follow up visits, ultrasound images will be used to delineate whether the amount of filler has decreased between visits. The analyses of the sonographic characteristics of the fillers will allow for optimization of treatment results.
Measured: Baseline to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2017
- Study start5 Dec 2017
- Primary completion15 Aug 2018
- Study completion8 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial Volume LossStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erevna Innovations Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas Nikolis, MD, Principal investigator, Erevna Innovations Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03381040
- Sponsor's protocol ID
- 2017-01-001G
- Status last verified
- Jan 2019
- First submitted
- 18 Dec 2017
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Algorithm for Product Selection in the Management of Mid Facial Volume Correction: Part I - A Pilot Validation of Patient Strata
- ClinicalTrials.gov ID
- NCT03381040
- Acronym / sponsor ID
- 2017-01-001G
- Conditions
- Facial Volume Loss
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Erevna Innovations Inc.University, hospital or other
- Study start
- 5 Dec 2017 (actual)
- Primary completion
- 15 Aug 2018 (actual)
- Study completion
- 8 Jan 2019 (actual)
- First posted
- 21 Dec 2017 (actual)
- 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.
This study seeks to determine whether patients pursuing injectable treatments for facial volume loss and/or contour deficiency can be separated into strata based on characteristics such as skin envelope and subcutaneous tissue quantity in the zygomatic, submalar and anteromedial cheek regions in order to guide the clinician in making the ideal product choice (i.e., Restylane Volyme vs Lyft)?
Detailed description
With age, loss of facial fat and hollowing of the cheeks can result in a "sinking" appearance in the mid-face. Augmentation and contouring of the area can be corrected using dermal fillers such as Restylane.
Currently, product choice and amount of volume used for injectable procedures varies between physicians as there is no standard for treatment. Individual assessment based on the attending physician's preference and experience determines final product selection and technique. An algorithm is needed to standardize best practices between physicians and clinics and to better regulate the use of dermal fillers in facial plastic surgery.
Therefore, the purpose of this study is to is to develop an algorithm to decide on which product (i.e., Restylane Volyme or Lyft) to use in the cheek area based on subject characteristics such as age, skin quality, subcutaneous fat quantity and positioning, and bony structure.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Device: Restylane LyftPoor structural support/volume (atrophy of soft tissues, leading to loss of projection) with adequate skin envelope (normal or thick skin). Treated with Restylane Lyft. |
| Group B | Active comparator | Device: Restylane VolymePoor structural support/volume (atrophy of soft tissues, leading to loss of projection) with poor skin envelope (thin skin). Treated with Restylane Volyme. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- At the time of consent, women between the ages of 30 and 75 years old;
- Patients with established mid-face/cheek hollowing;
- Patients with a MMVS score of 2 or 3 at baseline;
- Accepted the obligation not to receive any other facial procedures through the 4-month follow-up;
- Understood and accepted the obligation and would be logistically able to appear for all scheduled follow-up visits;
Key exclusion criteria (20 listed)
- Current Pregnancy or lactation [sexually active women of childbearing age must agree to use medically acceptable methods of contraception for the duration of this study (e.g., oral contraceptives, condoms, intrauterine device, shot/injection, patch)].;
- Hypersensitivity to Restylane products, hyaluronic acid filler or amide local anesthetics;
- Patients presenting with porphyria;
- Inability to comply with follow-up and abstain from facial injections during the study period;
- Heavy smokers, classified as smoking more than 12 cigarettes per day;
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 |
|---|---|---|
| Restylane LyftRestylane® Lyft is a sterile gel of hyaluronic acid with lidocaine generated by Streptococcus species of bacteria, chemically cross-linked with BDDE (the cross linker), stabilized and suspended in phosphate buffered saline at pH=7 and concentration of 20 mg/mL. Lyft is intended to be used for facial tissue augmentation. It is recommended that the product be used for shaping the contours of the face and the correction of folds using the co-packed needles. Given the very high lift capacity of Lyft, it is often used when the skin envelope is normal or thicker than normal, as the contours of the product may be palpable in the presence of thin skin. | Device | Group A |
| Restylane VolymeRestylane® Volyme is a sterile, biodegradable, viscoelastic, non-pyrogenic, clear, colorless, and homogeneous soft hyaluronic acid gel with a high lifting capacity. Volyme is intended for injection into the supraperiostic zone or subcutis to augment the volume of the cheeks. Given Volyme's viscoelastic and lifting capacities, it is best used when there is significant loss of volume and a thin skin envelope. | Device | Group B |
Primary outcome
Comparison of two Restylane products to treat mid-face/cheek deformities.
Time frame: Baseline and Week 16.
Investigators will evaluate whether a difference in physician assessed efficacy as per the standardized photos between two Restylane products at 16 weeks (visit 5) in comparison to baseline (visit 1) using the GAIS scale.
5 secondary outcomes
Standardized Imagery for the Improvement of Mid-face Hollowing
Time frame: Baseline to week 8
Patient satisfaction questionnaire
Time frame: Baseline to 16 weeks
Global aesthetic improvement scale
Time frame: Baseline to 16 weeks
Medicis Mid-face Volume Scale
Time frame: Baseline to 16 weeks
Standardized Ultrasonography Images
Time frame: Baseline to 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2019.
- Individual participant dataSharing planned: No
Related trials for Facial Volume Loss
RecruitingPhase 4
Restoring Facial Volume After GLP-1 Weight Loss With Radiesse
Volume Loss (Soft Tissue Ptosis or Atrophy )
Not yet recruitingObservational study
Comparing Facial Aging Between Identical Twins With 3D Imaging
Facial Skin Aging, Facial Volume Loss
Active, not recruiting
Hyaluronic Acid Crosslinking Clinical Study
Facial Aging, Skin Aging
Active, not recruiting
Evaluation of Performance and Safety of Injectable KIO017 Device Range for Facial Tissue Filling
Dermal Fillers, Cheek Augmentation
Not yet recruitingPhase 4
Assess Injectable Hyaluronic Acid Gel for the Treatment of Volume Loss, Skin Laxity and Fine Lines
Fine Lines, Wrinkle
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.
Andreas Nikolis, MD principal investigator
Erevna Innovations Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Restylane Lyft and Restylane Volyme in people with Facial Volume Loss, run by Erevna Innovations Inc. at 1 site in Canada.
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 8 inclusion and 20 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: finished, as of the sponsor's last update on 10 Jan 2019. 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 Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of two Restylane products to treat mid-face/cheek deformities. (time frame: Baseline and Week 16.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2019.