NOA VOLUME Gel for Midface Volume Loss

Recruiting at 3 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AbbVie

Disqualifiers: Skin laxity, Pigmentation disorders, Infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 month

231 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What data supports the effectiveness of the treatment NOA VOLUME Gel for midface volume loss?

Research shows that hyaluronic acid-based gels, like NOA VOLUME, are effective in restoring facial volume. Studies on similar treatments have demonstrated their ability to enhance facial contours and improve patient satisfaction. ^{1 2 3 4 5}

What makes NOA VOLUME Gel unique for treating midface volume loss?

NOA VOLUME Gel is unique because it is an injectable gel specifically designed for midface volume enhancement, potentially offering a novel formulation or technique compared to other hyaluronic acid-based fillers, which are commonly used for similar purposes. ^{1 2 3 4 6}

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

This trial is for adults with moderate to severe mid-face volume loss who could benefit from facial filler injections. Participants must have a certain level of volume deficit that can be improved by the treatment, as judged by the investigator.

Inclusion Criteria

My mid-face area has a noticeable volume loss.

My mid-face can improve with treatment, as per my doctor's judgment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive NOA VOLUME or VOLUMA XC injections in the cheek on Day 1, with optional touch-up treatment on Day 31

1 month

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with optional repeat treatments at Month 12, 15, or 18

Up to 22 months

Treatment Details

Interventions

• NOA VOLUME

Trial Overview The study compares NOA VOLUME, a new Hyaluronic Acid gel implant with lidocaine, against JUVÉDERM VOLUMA XC for increasing mid-face volume. Patients will receive treatments via cheek injections and may get touch-ups or repeat treatments over up to 22 months.

Participant Groups

Group I: Cohort 2: VOLUMA XC Experimental Treatment 1 Intervention

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

Group II: Cohort 2: NOA VOLUME Experimental Treatment 1 Intervention

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

Group III: Cohort 1: VOLUMA XC Experimental Treatment 1 Intervention

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

Group IV: Cohort 1: NOA VOLUME Experimental Treatment 1 Intervention

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

NOA VOLUME is already approved in United States for the following indications:

Approved in United States as NOA VOLUME Injectable Gel for:

• Improvement of mid-face volume deficit

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Findings from Research

In a study involving 40 healthy female patients aged 30 to 65, the HA-based gel filler Stylage XL Lidocaine significantly improved facial volume, with mean facial volume loss scores decreasing from 3.1 to 2.3 after 6 months (P < .0001).

The treatment was well tolerated and maintained aesthetic improvements for up to 18 months, confirming both the efficacy and safety of Stylage XL Lidocaine for facial volume restoration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Stylage XL Lidocaine for the Restoration and/or Augmentation of Facial Volume: The Beauty Volume Study. Mojallal, A.[2023]

In a study involving 60 subjects, the use of large gel particle hyaluronic acid with lidocaine injected via blunt-tip microcannulas showed a favorable safety profile, with only one mild adverse event reported and no serious complications.

The treatment was highly effective for cheek augmentation and correcting midface volume loss, with over 98% of subjects reporting aesthetic improvements and a 100% responder rate on the Medicis Midface Volume Scale at 8 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microcannula Injection of Large Gel Particle Hyaluronic Acid for Cheek Augmentation and the Correction of Age-Related Midface Contour Deficiencies. Jones, DH., Hessler, J., Chapas, A., et al.[2021]

In a six-month study involving multiple centers, HA E Volume injections significantly improved cheek volume in patients with age-related volume loss, with 89.3% of subjects reporting aesthetic improvement at three weeks post-injection.

The treatment demonstrated good safety and tolerability, with 92.1% of participants expressing satisfaction with their results, and 65.8% of the initial volume correction maintained after six months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustained efficacy and high patient satisfaction after cheek enhancement with a new hyaluronic acid dermal filler. Kestemont, P., Cartier, H., Trevidic, P., et al.[2015]

In a study involving 115 healthy subjects, Juvéderm® VOLUMA® with Lidocaine demonstrated high effectiveness for mid-face augmentation, with 95.6% of participants reporting satisfaction immediately after treatment and 93.7% at 21 days post-treatment.

The treatment was well tolerated, with minimal pain reported, primarily related to the injection procedure, indicating a favorable safety profile for this hyaluronic acid-based gel.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective, observational study of the volumizing effect of open-label aesthetic use of Juvéderm® VOLUMA® with Lidocaine in mid-face area. Philipp-Dormston, WG., Eccleston, D., De Boulle, K., et al.[2015]

In a 6-month study involving 60 adults aged 40-65, hyaluronic acid gel significantly improved facial volume loss and contour deficiency, as measured by the Facial Volume Loss Scale (FVLS) and Global Aesthetic Improvement Scale (GAIS).

While 100% of participants showed improvement at 3 months, 91% maintained improvement at 6 months, indicating that hyaluronic acid gel is both effective and safe for treating volume loss in the face.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a new hyaluronic acid dermal filler for volume restoration. Alessandrini, A., Fino, P., Giordan, N., et al.[2015]

A new technique for midface rejuvenation involves a single injection of cross-linked hyaluronic acid at the subdermal level, which enhances facial volume effectively and is well tolerated by patients.

This method may lead to less bruising compared to traditional deeper injection techniques, making it a simpler and quicker option for achieving attractive cheekbone and malar fullness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A single injection technique for midface rejuvenation. Cattin, TA.[2013]

References

1. England pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Stylage XL Lidocaine for the Restoration and/or Augmentation of Facial Volume: The Beauty Volume Study. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Microcannula Injection of Large Gel Particle Hyaluronic Acid for Cheek Augmentation and the Correction of Age-Related Midface Contour Deficiencies. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Sustained efficacy and high patient satisfaction after cheek enhancement with a new hyaluronic acid dermal filler. [2015]

4. England pubmed.ncbi.nlm.nih.gov

A prospective, observational study of the volumizing effect of open-label aesthetic use of Juvéderm® VOLUMA® with Lidocaine in mid-face area. [2015]

5. England pubmed.ncbi.nlm.nih.gov

Evaluation of a new hyaluronic acid dermal filler for volume restoration. [2015]

6. England pubmed.ncbi.nlm.nih.gov

A single injection technique for midface rejuvenation. [2013]