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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

AbbVie · NCT06734351

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 22+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
231
US sites recruiting
15
Study start
December 16, 2024
Record last updated
June 18, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: NOA VOLUME; VOLUMA XC

Conditions: Mid Face Volume Deficit

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

  • Total Skin and Beauty Dermatology Center /ID# 258164

    Birmingham, AL 35205

  • Advanced Research Associates - Glendale /ID# 276812

    Glendale, AZ 85308

  • West Dermatology La Jolla /ID# 278590

    San Diego, CA 92121

  • Susan H. Weinkle MD /ID# 258160

    Bradenton, FL 34209-5642

  • Hevia Cosmetic Dermatology /ID# 258165

    Coral Gables, FL 33134

  • Skin Research Institute LLC /ID# 258158

    Coral Gables, FL 33146-1837

  • Atlanta Biomedical Clinical Research /ID# 261210

    Atlanta, GA 30331-2160

    Site contact: Site Coordinator · 678-515-3446

  • Pure Dermatology /ID# 258168

    Metairie, LA 70001

  • Aesthetic Center at Woodholme /ID# 258166

    Baltimore, MD 21208-6391

  • Edwin F. Williams III, MD FACS of LATHAM P.C. D/B/A THE REJUVA CENTER /ID# 261211

    Latham, NY 12110

  • Jane Yoo MD /ID# 279811

    New York, NY 10019

  • Northwest Dermatology Institute /ID# 258167

    Portland, OR 97210-2859

  • Westlake Dermatology & Cosmetic Surgery - Westlake /ID# 258156

    Austin, TX 78746-4720

  • SkinDC /ID# 258163

    Arlington, VA 22209

  • EthiQ2 Research, LLC /ID# 258906

    Brookfield, WI 53005

Study contacts (from the official record)

  • ABBVIE CALL CENTER · 844-663-3742 · abbvieclinicaltrials@abbvie.com
A Study to Evaluate Safety and Effectiveness of NOA VOLUME… (NCT06734351) | Bored Studies