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

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 Overview

• Status: Recruiting
• Conditions: Mid Face Volume Deficit
• Intervention / Treatment: Device: NOA VOLUME; Device: VOLUMA XC

• Study Type: Interventional
• Enrollment (Estimated): 231
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Recruiting
      • Total Skin and Beauty Dermatology Center /ID# 258164
  • Arizona
    • Glendale, Arizona, United States, 85308
      • Recruiting
      • Advanced Research Associates - Glendale /ID# 276812
  • California
    • San Diego, California, United States, 92121
      • Recruiting
      • West Dermatology La Jolla /ID# 278590
  • Florida
    • Bradenton, Florida, United States, 34209-5642
      • Recruiting
      • Susan H. Weinkle MD /ID# 258160
    • Coral Gables, Florida, United States, 33146-1837
      • Recruiting
      • Skin Research Institute LLC /ID# 258158
    • Coral Gables, Florida, United States, 33134
      • Recruiting
      • Hevia Cosmetic Dermatology /ID# 258165
  • Georgia
    • Atlanta, Georgia, United States, 30331-2160
      • Recruiting
      • Atlanta Biomedical Clinical Research /ID# 261210
      • Contact: Site Coordinator; Phone Number: 678-515-3446
  • Louisiana
    • Metairie, Louisiana, United States, 70001
      • Recruiting
      • Pure Dermatology /ID# 258168
  • Maryland
    • Baltimore, Maryland, United States, 21208-6391
      • Recruiting
      • Aesthetic Center at Woodholme /ID# 258166
  • New York
    • Latham, New York, United States, 12110
      • Recruiting
      • Edwin F. Williams III, MD FACS of LATHAM P.C. D/B/A THE REJUVA CENTER /ID# 261211
  • Oregon
    • Portland, Oregon, United States, 97210-2859
      • Recruiting
      • Northwest Dermatology Institute /ID# 258167
  • Texas
    • Austin, Texas, United States, 78746-4720
      • Recruiting
      • Westlake Dermatology & Cosmetic Surgery - Westlake /ID# 258156
  • Virginia
    • Arlington, Virginia, United States, 22209
      • Recruiting
      • SkinDC /ID# 258163
  • Wisconsin
    • Brookfield, Wisconsin, United States, 53005
      • Recruiting
      • EthiQ2 Research, LLC /ID# 258906

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1: NOA VOLUME; Participants will receive NOA VOLUME on Day 1 with optional touch-up treatment on Day 31 and Month 18.	Device: NOA VOLUME; Injections
Experimental: Cohort 1: VOLUMA XC; Participants will receive VOLUMA XC on Day 1 with optional touch-up treatment on Day 31 and Month 18.	Device: VOLUMA XC; Injections; Other Names: JUVÉDERM
Experimental: Cohort 2: NOA VOLUME; Participants will receive NOA VOLUME on Day 1 with optional touch-up treatment on Day 31 and Month 18.	Device: NOA VOLUME; Injections
Experimental: Cohort 2: VOLUMA XC; Participants will receive VOLUMA XC on Day 1 with optional touch-up treatment on Day 31 and Month 18.	Device: VOLUMA XC; Injections; Other Names: JUVÉDERM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2024
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2029

Study Registration Dates

• First Submitted: December 11, 2024
• First Submitted That Met QC Criteria: December 11, 2024
• First Posted (Actual): December 16, 2024

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Mid Face Volume Deficit; NOA VOLUME; JUVÉDERM® VOLUMA® XC
• Other Study ID Numbers: M21-841

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No