Assessing a new injectable gel for improving 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

This study is testing a new injectable gel to see if it can safely and effectively restore volume in the mid-face for adults who have lost fullness due to aging, comparing it to an existing treatment.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 231 (estimated)
• Ages: 22 Years and up
• Sex: All
• Sponsor: AbbVie (industry)
• Locations: 11 sites (Birmingham, Alabama and 10 other locations)
• Trial ID: NCT06734351 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of NOA VOLUME, a crosslinked Hyaluronic Acid gel, in restoring mid-face volume in adults compared to JUVÉDERM VOLUMA XC. Participants will be divided into two cohorts, receiving either NOA VOLUME or VOLUMA XC, with follow-up assessments to determine improvements in facial fullness. The study aims to provide a minimally invasive solution for individuals experiencing volume loss due to aging.

Who should consider this trial

Good fit: Ideal candidates are adults with moderate to severe mid-face volume deficits who are seeking improvement in facial fullness.

Not a fit: Patients with significant skin laxity or active skin conditions in the mid-face area may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer patients a safe and effective option for enhancing mid-face volume and achieving a more youthful appearance.

How similar studies have performed: Other studies have shown positive outcomes with similar injectable treatments, suggesting a potential for success with this approach.

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.

Where this trial is running

Birmingham, Alabama and 10 other locations

• Total Skin and Beauty Dermatology Center /ID# 258164 — Birmingham, Alabama, United States (RECRUITING)
• Advanced Research Associates - Glendale /ID# 276812 — Glendale, Arizona, United States (RECRUITING)
• Susan H. Weinkle MD /ID# 258160 — Bradenton, Florida, United States (RECRUITING)
• Hevia Cosmetic Dermatology /ID# 258165 — Coral Gables, Florida, United States (RECRUITING)
• Skin Research Institute LLC /ID# 258158 — Coral Gables, Florida, United States (RECRUITING)
• Atlanta Biomedical Clinical Research /ID# 261210 — Atlanta, Georgia, United States (RECRUITING)
• Pure Dermatology /ID# 258168 — Metairie, Louisiana, United States (RECRUITING)
• Aesthetic Center at Woodholme /ID# 258166 — Baltimore, Maryland, United States (RECRUITING)
• Edwin F. Williams III, MD FACS of LATHAM P.C. D/B/A THE REJUVA CENTER /ID# 261211 — Latham, New York, United States (RECRUITING)
• Westlake Dermatology & Cosmetic Surgery - Westlake /ID# 258156 — Austin, Texas, United States (RECRUITING)
• EthiQ2 Research, LLC /ID# 258906 — Brookfield, Wisconsin, United States (RECRUITING)

Study contacts

• Study coordinator: ABBVIE CALL CENTER

Conditions: Mid Face Volume Deficit, NOA VOLUME, JUVÉDERM® VOLUMA® XC