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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

RecruitingPhase 3Ages 22 Years - anyAllAbbVie
NCT06734351 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 23

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📋 Eligibility rules (as published)
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.
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What it tests

  • NOA VOLUME
  • VOLUMA XC
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Where

15 sites
Total Skin and Beauty Dermatology Center /ID# 258164
Birmingham, United States
Advanced Research Associates - Glendale /ID# 276812
Glendale, United States
West Dermatology La Jolla /ID# 278590
San Diego, United States
Susan H. Weinkle MD /ID# 258160
Bradenton, United States
Hevia Cosmetic Dermatology /ID# 258165
Coral Gables, United States
Skin Research Institute LLC /ID# 258158
Coral Gables, United States
Atlanta Biomedical Clinical Research /ID# 261210
Atlanta, United States
Pure Dermatology /ID# 258168
Metairie, United States

…and 7 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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