A Study to Assess Safety and Effectiveness of Injections of NOA VOLUME Injectable Gel in Adult Participants Compared to JUVÉDERM VOLUMA XC for Change of Mid-Face Volume

AbbVie

Status and phase: Enrolling; Phase 3

Conditions: Mid Face Volume Deficit

Treatments: Device: VOLUMA XC; Device: NOA VOLUME

Study type: Interventional

Funder types: Industry

Identifiers

NCT06734351

M21-841

Details and patient eligibility

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) gel implant 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. In Cohort 1, participants will receive either NOA VOLUME or VOLUMA XC with a fixed follow-up period. In Cohort 2, participants will receive either NOA VOLUME or VOLUMA XC with a variable follow-up period. 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 as subcutaneous and/or supraperiosteal plane injections in the cheek on Day 1. Participants will receive optional touch-up treatment at Day 31 and optional repeat treatment at Month 18 for Cohort 1 and at Month 12, 15, or 18 for Cohort 2 and will be followed up for up to 22 months.

Enrollment: 231 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

231 participants in 4 patient groups

Cohort 1: NOA VOLUME

Experimental group

Description:

Participants will receive NOA VOLUME on Day 1 with optional touch-up treatment on Day 31 and Month 18.

Treatment:

Device: NOA VOLUME

Cohort 1: VOLUMA XC

Experimental group

Description:

Participants will receive VOLUMA XC on Day 1 with optional touch-up treatment on Day 31 and Month 18.

Treatment:

Device: VOLUMA XC

Cohort 2: NOA VOLUME

Experimental group

Description:

Participants will receive NOA VOLUME on Day 1 with optional touch-up treatment on Day 31 and at either Month 12, 15, or 18.

Treatment:

Device: NOA VOLUME

Cohort 2: VOLUMA XC

Experimental group

Description:

Participants will receive VOLUMA XC on Day 1 with optional touch-up treatment on Day 31 and at either Month 12, 15, or 18.

Treatment:

Device: VOLUMA XC