A Study to Evaluate Safety and Effectiveness of NOA VOLUME Injectable Gel in Adult Participants Compared to JUVÉDERM VOLUMA XC for Improvement of Mid-Face Volume
A Multicenter, Evaluator and Subject-blinded, Randomized, Comparator-controlled, Parallel-design Study to Evaluate the Safety and Effectiveness of NOA VOLUME Compared to JUVÉDERM® VOLUMA® XC for Improvement of Mid-face Volume
1 other identifier
interventional
231
1 country
9
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2024
Longer than P75 for phase_3
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 11, 2024
CompletedFirst Posted
Study publicly available on registry
December 16, 2024
CompletedStudy Start
First participant enrolled
December 16, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2029
March 31, 2026
March 1, 2026
4.5 years
December 11, 2024
March 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (3)
Change from Baseline in the Overall Score of FACE-Q Satisfaction with Cheeks
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)
Month 6
Percentage of Participants Achieving "Responder" Status Based on EI's Assessments of Global Aesthetic Improvement in the Treatment Area Using the GAIS
Month 6
Study Arms (4)
Cohort 1: NOA VOLUME
EXPERIMENTALParticipants will receive NOA VOLUME on Day 1 with optional touch-up treatment on Day 31 and Month 18.
Cohort 1: VOLUMA XC
EXPERIMENTALParticipants will receive VOLUMA XC on Day 1 with optional touch-up treatment on Day 31 and Month 18.
Cohort 2: NOA VOLUME
EXPERIMENTALParticipants will receive NOA VOLUME on Day 1 with optional touch-up treatment on Day 31 and Month 18.
Cohort 2: VOLUMA XC
EXPERIMENTALParticipants will receive VOLUMA XC on Day 1 with optional touch-up treatment on Day 31 and Month 18.
Interventions
Eligibility Criteria
You may qualify if:
- Has moderate (3), significant (4), or severe (5) mid-face volume deficit on the 5-point photonumeric MFVDS based on evaluating investigator's (EI) live assessment.
- Mid-face is amenable to achieving at least a 1-point improvement in MFVDS score with the allowed injection volume in the treating investigator's (TI) judgement.
You may not qualify if:
- Significant skin laxity in the midface in the opinion of the TI.
- Significant skin pigmentation disorders or discoloration in the mid-face area that would interfere with the visual assessment of the mid-face area.
- Current cutaneous inflammatory or infectious processes (e.g., acne, herpes), abscess, unhealed wound, or cancerous or precancerous lesion on the face.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (9)
Total Skin and Beauty Dermatology Center /ID# 258164
Birmingham, Alabama, 35205, United States
Advanced Research Associates - Glendale /ID# 276812
Glendale, Arizona, 85308, United States
Susan H. Weinkle MD /ID# 258160
Bradenton, Florida, 34209-5642, United States
Hevia Cosmetic Dermatology /ID# 258165
Coral Gables, Florida, 33134, United States
Skin Research Institute LLC /ID# 258158
Coral Gables, Florida, 33146-1837, United States
Atlanta Biomedical Clinical Research /ID# 261210
Atlanta, Georgia, 30331-2160, United States
Pure Dermatology /ID# 258168
Metairie, Louisiana, 70001, United States
Aesthetic Center at Woodholme /ID# 258166
Baltimore, Maryland, 21208-6391, United States
Westlake Dermatology & Cosmetic Surgery - Westlake /ID# 258156
Austin, Texas, 78746-4720, United States
Related Links
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 11, 2024
First Posted
December 16, 2024
Study Start
December 16, 2024
Primary Completion (Estimated)
July 1, 2029
Study Completion (Estimated)
July 1, 2029
Last Updated
March 31, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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.