Midfacial Product Selection
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|ClinicalTrials.gov Identifier: NCT03381040|
Recruitment Status : Active, not recruiting
First Posted : December 21, 2017
Last Update Posted : July 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Facial Volume Loss||Device: Restylane Lyft Device: Restylane Volyme||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Predictive Algorithm for Product Selection in the Management of Mid Facial Volume Correction: Part I - A Pilot Validation of Patient Strata|
|Actual Study Start Date :||December 5, 2017|
|Estimated Primary Completion Date :||August 15, 2018|
|Estimated Study Completion Date :||September 1, 2018|
Active Comparator: Group A
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.
Device: Restylane Lyft
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.
Active Comparator: Group B
Poor structural support/volume (atrophy of soft tissues, leading to loss of projection) with poor skin envelope (thin skin). Treated with Restylane Volyme.
Device: Restylane Volyme
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.
- 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.
- Standardized Imagery for the Improvement of Mid-face Hollowing [ Time Frame: Baseline to week 8 ]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.
- Patient satisfaction questionnaire [ Time Frame: Baseline to 16 weeks ]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'.
- Global aesthetic improvement scale [ Time Frame: Baseline to 16 weeks ]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'.
- Medicis Mid-face Volume Scale [ Time Frame: Baseline to 16 weeks ]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.
- Standardized Ultrasonography Images [ Time Frame: Baseline to 16 weeks ]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.
- Adverse events [ Time Frame: Baseline to 16 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03381040
|Victoria Park Clinical Research Centre|
|Westmount, Quebec, Canada, H3Z1C3|
|Principal Investigator:||Andreas Nikolis, MD||Erevna Innovations Inc.|