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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called NOA VOLUME, a gel designed to restore fullness in the mid-face and bring back a youthful look. The study compares NOA VOLUME with another treatment, VOLUMA XC, to determine which is safer and more effective. Participants will receive injections and may undergo touch-up treatments over time. This trial suits adults with noticeable facial volume loss who believe treatment could improve their facial fullness. Those with significant skin issues or facial infections might not qualify for the study. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment.

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 prior data suggests that this gel implant is safe for mid-face volume improvement?

In previous studies, NOA VOLUME, a gel made from hyaluronic acid (a substance naturally found in the body), has proven to be safe and easy to use for improving mid-face volume. This gel also contains lidocaine to reduce pain during treatment. Research shows that hyaluronic acid fillers are generally well-tolerated, with side effects usually mild and temporary, such as swelling or bruising at the injection site.

JUVÉDERM VOLUMA XC, the treatment compared in this trial, is an FDA-approved product for enhancing cheeks. It has a proven safety record with similar mild side effects, like redness or tenderness, which also tend to be short-lived.

Both treatments have been used in other situations, supporting their general safety. However, this trial specifically studies NOA VOLUME for mid-face volume loss, so ongoing research will provide more specific safety information. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for midface volume loss?

Researchers are excited about NOA VOLUME for midface volume loss because it offers a new approach to facial rejuvenation. Unlike traditional fillers like VOLUMA XC, which primarily use hyaluronic acid, NOA VOLUME may incorporate unique components or a different formulation that provides more natural or longer-lasting results. This innovative treatment could potentially enhance facial volume with fewer sessions and maintain the desired look for an extended period, offering patients a more convenient and effective solution.

What evidence suggests that this trial's treatments could be effective for mid-face volume loss?

Research shows that gels made from hyaluronic acid, such as NOA VOLUME, can effectively restore facial volume. Previous studies have demonstrated that similar treatments significantly improve the fullness of the mid-face area. Specifically, one study found that participants experienced an average increase in facial volume of about 4.46 mL just 45 days after treatment. This trial will compare NOA VOLUME with VOLUMA XC, both designed to enhance mid-face volume and provide a more youthful look. These treatments are designed to be safe and involve minimal procedures, making them attractive choices for those seeking to refresh their facial appearance. ^{1 2 3 4 6}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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 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]

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]

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06734351

NCT06734351 | A Study to Assess Safety and ... 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- ...

2. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=M21-841

A Study to Assess Safety and Effectiveness of Injections ... 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- ...

3. withpower.com withpower.com/trial/noa-volume-gel-for-midface-volume-loss-5dc96

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 ...

4. ctv.veeva.com ctv.veeva.com/study/a-study-to-assess-adverse-events-and-effectiveness-of-injections-of-noa-volume-injectable-gel-in-adu

A Study to Assess Safety and Effectiveness of Injections of ... 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 ...

5. mdpi.com mdpi.com/2673-4095/6/1/21

Volume Restoration in Mid-Facial Aging Results: In total, 39 out of 47 patients completed the study, which showed an overall volume restoration of 4.46 ± 1.34 mL at 45 days (t0–t1) after HA ...

6. cochranelibrary.com cochranelibrary.com/content?templateType=related&urlTitle=/central/doi/10.1002/central/CN-02029579&doi=10.1002/central/CN-02029579&p_p_id=scolariscontentdisplay_WAR_scolariscontentdisplay&_scolariscontentdisplay_WAR_scolariscontentdisplay_action=related-content&p_p_lifecycle=0&p_p_mode=view&type=central&contentLanguage=

Safety and Effectiveness of Juvéderm® VOLUMA XC ... 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- ...