Actively Recruiting
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
Led by AbbVie · Updated on 2026-05-13
231
Participants Needed
11
Research Sites
236 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has moderate (3), significant (4), or severe (5) mid-face volume deficit on the 5-point photonumeric MFVDS based on evaluating investigator's 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 judgement
You will not qualify if you...
- Significant skin laxity in the midface as judged by the treating investigator
- Significant skin pigmentation disorders or discoloration in the mid-face area that interfere with visual assessment
- Current cutaneous inflammatory or infectious issues such as acne, herpes, abscess, unhealed wounds, or cancerous or precancerous lesions on the face
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
Total Skin and Beauty Dermatology Center /ID# 258164
Birmingham, Alabama, United States, 35205
Actively Recruiting
2
Advanced Research Associates - Glendale /ID# 276812
Glendale, Arizona, United States, 85308
Actively Recruiting
3
Susan H. Weinkle MD /ID# 258160
Bradenton, Florida, United States, 34209-5642
Actively Recruiting
4
Hevia Cosmetic Dermatology /ID# 258165
Coral Gables, Florida, United States, 33134
Actively Recruiting
5
Skin Research Institute LLC /ID# 258158
Coral Gables, Florida, United States, 33146-1837
Actively Recruiting
6
Atlanta Biomedical Clinical Research /ID# 261210
Atlanta, Georgia, United States, 30331-2160
Actively Recruiting
7
Pure Dermatology /ID# 258168
Metairie, Louisiana, United States, 70001
Actively Recruiting
8
Aesthetic Center at Woodholme /ID# 258166
Baltimore, Maryland, United States, 21208-6391
Actively Recruiting
9
Edwin F. Williams III, MD FACS of LATHAM P.C. D/B/A THE REJUVA CENTER /ID# 261211
Latham, New York, United States, 12110
Actively Recruiting
10
Westlake Dermatology & Cosmetic Surgery - Westlake /ID# 258156
Austin, Texas, United States, 78746-4720
Actively Recruiting
11
EthiQ2 Research, LLC /ID# 258906
Brookfield, Wisconsin, United States, 53005
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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