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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: NOA VOLUME | Experimental | Participants will receive NOA VOLUME on Day 1 with optional touch-up treatment on Day 31 and Month 18. |
|
| Cohort 1: VOLUMA XC | Experimental | Participants will receive VOLUMA XC on Day 1 with optional touch-up treatment on Day 31 and Month 18. |
|
| Cohort 2: NOA VOLUME | Experimental | Participants will receive NOA VOLUME on Day 1 with optional touch-up treatment on Day 31 and Month 18. |
|
| Cohort 2: VOLUMA XC | Experimental | Participants will receive VOLUMA XC on Day 1 with optional touch-up treatment on Day 31 and Month 18. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NOA VOLUME | Device | Injections |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage 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). | 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. | Up to Approximately Month 31 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ABBVIE CALL CENTER | Contact | 844-663-3742 | abbvieclinicaltrials@abbvie.com |
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Total Skin and Beauty Dermatology Center /ID# 258164 | Recruiting | Birmingham | Alabama | 35205 | United States | |
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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| VOLUMA XC |
| Device |
Injections |
|
|
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). |
| 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). | Month 6 |
| Advanced Research Associates - Glendale /ID# 276812 |
| Recruiting |
| Glendale |
| Arizona |
| 85308 |
| United States |
| West Dermatology La Jolla /ID# 278590 | Recruiting | San Diego | California | 92121 | United States |
| Susan H. Weinkle MD /ID# 258160 | Recruiting | Bradenton | Florida | 34209-5642 | United States |
| Hevia Cosmetic Dermatology /ID# 258165 | Recruiting | Coral Gables | Florida | 33134 | United States |
| Skin Research Institute LLC /ID# 258158 | Recruiting | Coral Gables | Florida | 33146-1837 | United States |
| Atlanta Biomedical Clinical Research /ID# 261210 | Recruiting | Atlanta | Georgia | 30331-2160 | United States |
|
| Pure Dermatology /ID# 258168 | Recruiting | Metairie | Louisiana | 70001 | United States |
| Aesthetic Center at Woodholme /ID# 258166 | Recruiting | Baltimore | Maryland | 21208-6391 | United States |
| Edwin F. Williams III, MD FACS of LATHAM P.C. D/B/A THE REJUVA CENTER /ID# 261211 | Recruiting | Latham | New York | 12110 | United States |
| Jane Yoo MD /ID# 279811 | Recruiting | New York | New York | 10019 | United States |
| Northwest Dermatology Institute /ID# 258167 | Recruiting | Portland | Oregon | 97210-2859 | United States |
| Westlake Dermatology & Cosmetic Surgery - Westlake /ID# 258156 | Recruiting | Austin | Texas | 78746-4720 | United States |
| SkinDC /ID# 258163 | Recruiting | Arlington | Virginia | 22209 | United States |
| EthiQ2 Research, LLC /ID# 258906 | Recruiting | Brookfield | Wisconsin | 53005 | United States |