Facial fullness is often regarded as a characteristic feature of a youthful face. Chronic reduction of collagen, elastin, and glycosaminoglycans contribute to the facial volume loss that characterizes the aging face. Volume restoration by replacing or augmenting soft tissue is critical to successful facial rejuvenation. NOA VOLUME is a crosslinked Hyaluronic Acid (HA) injectable gel formulated with lidocaine that was developed to provide a safe, minimally invasive method of improving mid-face volume deficit. The purpose of this study is to assess safety and effectiveness of NOA VOLUME in adult participants seeking improvement of mid-face volume compared to JUVÉDERM VOLUMA XC (VOLUMA XC). NOA VOLUME is an investigational device being developed for the improvement of mid-face volume. There will be 2 cohorts in this study. Participants will receive either NOA VOLUME or VOLUMA XC. Around 231 adult participants seeking improvement of mid-face volume will be enrolled in the study at approximately 15 sites in the United States. Participants will receive either NOA VOLUME or VOLUMA XC injections in the cheek area on Day 1. Participants will receive optional touch-up treatment at Day 31 and optional repeat treatment at Month 18 and will be followed up for up to 31 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
231
Injections
Injections
Total Skin and Beauty Dermatology Center /ID# 258164
Birmingham, Alabama, United States
RECRUITINGAdvanced Research Associates - Glendale /ID# 276812
Glendale, Arizona, United States
RECRUITINGSusan H. Weinkle MD /ID# 258160
Bradenton, Florida, United States
RECRUITINGHevia Cosmetic Dermatology /ID# 258165
Coral Gables, Florida, United States
RECRUITINGSkin Research Institute LLC /ID# 258158
Coral Gables, Florida, United States
RECRUITINGAtlanta Biomedical Clinical Research /ID# 261210
Atlanta, Georgia, United States
RECRUITINGPure Dermatology /ID# 258168
Metairie, Louisiana, United States
RECRUITINGAesthetic Center at Woodholme /ID# 258166
Baltimore, Maryland, United States
RECRUITINGEdwin F. Williams III, MD FACS of LATHAM P.C. D/B/A THE REJUVA CENTER /ID# 261211
Latham, New York, United States
RECRUITINGWestlake Dermatology & Cosmetic Surgery - Westlake /ID# 258156
Austin, Texas, United States
RECRUITINGPercentage of Participants Achieving "Responder" Status Based on the Evaluating Investigator's (EI) Live Assessment of Mid-Face Volume Deficit Scale (MFVDS)
A "responder" is defined as a participant with at least 1-point improvement (reduction) of mid face volume deficit using the MFVDS. MFVDS is a validated 5-point scale (1 = None/Minimal to 5 = Severe).
Time frame: Month 6
Number of Participants with Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Time frame: Up to Approximately Month 31
Change from Baseline in the Overall Score of FACE-Q Satisfaction with Cheeks
The FACE-Q Satisfaction with Cheeks questionnaire is a 5-point survey where 1 = Very Dissatisfied and 4 = Very Satisfied.
Time frame: Month 6
Percentage of Participants Achieving "Responder" Status Based on Participant's Assessments of Global Aesthetic Improvement in the Treatment Area Using Global Aesthetic Improvement Scale (GAIS)
A "responder" is defined as a participant who achieves "Improved" or "Much Improved" on GAIS. GAIS is a 5-point scale used to assess global aesthetic improvement of the treatment area (2 = Much Improved to -2 = Much Worse).
Time frame: Month 6
Percentage of Participants Achieving "Responder" Status Based on EI's Assessments of Global Aesthetic Improvement in the Treatment Area Using the GAIS
A "responder" is defined as a participant who achieves "Improved" or "Much Improved" on GAIS. GAIS is a 5-point scale used to assess global aesthetic improvement of the treatment area (2 = Much Improved, -2 = Much Worse).
Time frame: Month 6
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.