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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NOA VOLUME, VOLUMA XC.
- Who it may be relevant to
- Registry conditions: Mid Face Volume Deficit. Basic parameters: from 22 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- Device NOA VOLUME
Injections - Device VOLUMA XC
Injections
Primary outcome measures
- Percentage of Participants Achieving "Responder" Status Based on the Evaluating Investigator's (EI) Live Assessment of Mid-Face Volume Deficit Scale (MFVDS) [Time frame: Month 6]
- Number of Participants with Adverse Events (AEs) [Time frame: Up to Approximately Month 31]
Secondary outcome measures (3)
- Change from Baseline in the Overall Score of FACE-Q Satisfaction with Cheeks [Time frame: 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) [Time frame: Month 6]
- Percentage of Participants Achieving "Responder" Status Based on EI's Assessments of Global Aesthetic Improvement in the Treatment Area Using the GAIS [Time frame: Month 6]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 15 centers
- Total Skin and Beauty Dermatology Center /ID# 258164 — Birmingham
- Advanced Research Associates - Glendale /ID# 276812 — Glendale
- West Dermatology La Jolla /ID# 278590 — San Diego
- Susan H. Weinkle MD /ID# 258160 — Bradenton
- Hevia Cosmetic Dermatology /ID# 258165 — Coral Gables
- Skin Research Institute LLC /ID# 258158 — Coral Gables
- Atlanta Biomedical Clinical Research /ID# 261210 — Atlanta
- Pure Dermatology /ID# 258168 — Metairie
- … and 7 more centers
Identifiers
NCT: NCT06734351 · M21-841