HArmonyCa Injectable Gel for Midface Volume Loss

Recruiting at 16 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Allergan

Must not be taking: Botulinum toxin

Disqualifiers: Facial trauma, Autoimmune disease, 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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

171 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new facial filler gel called HArmonyCa Lidocaine to see if it safely and effectively improves mid-face appearance in adults. The gel is injected to add volume and reduce wrinkles. Participants will be monitored for side effects and results over an extended period.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, certain cosmetic procedures and treatments, like botulinum toxin or dermal fillers, must not have been done recently. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the drug HArmonyCa Lidocaine Injectable Gel for midface volume loss?

Research shows that hyaluronic acid gels, like those in HArmonyCa, are effective for facial volume restoration, as seen in studies with similar products like Juvéderm® VOLUMA® with Lidocaine. These gels help restore facial volume and are commonly used for aesthetic improvements. ^{1 2 3 4 5}

Is HArmonyCa Injectable Gel safe for humans?

Research on similar products, like hyaluronic acid gels with lidocaine, shows they are generally safe for facial volume treatments, with mild and expected side effects such as bruising. Studies indicate that adding lidocaine to these gels does not change their safety profile. ^{1 3 6 7 8}

What makes HArmonyCa Lidocaine Injectable Gel unique for treating midface volume loss?

HArmonyCa Lidocaine Injectable Gel is unique because it combines hyaluronic acid (a substance that helps add volume and smoothness to the skin) with lidocaine (a pain reliever) to provide both aesthetic improvement and comfort during the procedure. This dual-action approach differentiates it from other treatments that may not include a pain-relieving component. ^{1 2 3 5 9}

Research Team

ALLERGAN INC.

Principal Investigator

Allergan

Eligibility Criteria

Adults in good health seeking to enhance their midface volume can join this trial. They must be able to consent and follow study rules, with no recent botulinum toxin or filler treatments, no tendency for keloid scarring, and not currently participating in other studies. Those with certain facial procedures, tattoos that affect assessment, recent dental work or planned during the study are excluded.

Inclusion Criteria

I am looking to get my mid-face area enhanced.

I can sign and follow the study's consent form and rules.

Participant must be in general good health

Exclusion Criteria

I have had a facial injury or still have scars or deformities from one within the last 6 months.

I have had semi-permanent facial fillers in the last 3 years.

I have skin or mucosal infections, wounds, or lesions on my face.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive HArmonyCa Lidocaine Injectable Gel on Day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with optional touch-up and repeat treatments

Up to 25 months

Regular visits (in-person)

Control Group Follow-up

Participants in the control group are followed for 3 months and can opt to receive treatment thereafter

3 months

Treatment Details

Interventions

• HArmonyCa Lidocaine Injectable Gel

Trial Overview The trial is testing HArmonyCa Lidocaine Injectable Gel as a dermal filler for midface augmentation. Participants will either receive the gel immediately or after a control period of 3 months. The treatment's effects are monitored over up to 25 months through medical assessments and questionnaires.

Participant Groups

Group I: HArmonyCa Lidocaine Injectable Gel Experimental Treatment 1 Intervention

Participants will receive HArmonyCa Lidocaine Injectable Gel on Day 1 and followed for up to 25 months. Participants will have the opportunity to receive optional touch-up and optional repeat treatment of HArmonyCa Lidocaine injectable gel during the follow-up duration period.

Group II: Control Group Experimental Treatment 1 Intervention

Participants will be followed for 3 months. Participants can opt to receive HArmonyCa Lidocaine Injectable Gel after 3 months and followed for up to 25 months.

Who Is Running the Clinical Trial?

Allergan

Lead Sponsor

Trials

782

Recruited

277,000+

Brent Saunders

Allergan

Chief Executive Officer since 2015

JD and MBA from Temple University

Dr. David Nicholson

Allergan

Chief Medical Officer since 2015

MD from Harvard Medical School

Findings from Research

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]

References

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

Effectiveness and Safety of Hyaluronic Acid Gel with Lidocaine for the Treatment of Nasolabial Folds: A Systematic Review and Meta-analysis. [2022]

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

Long-term Safety and Effectiveness of Hyaluronic Acid Fillers Correcting Nasolabial Folds in Chinese Patients. [2023]

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

Evaluation of the efficacy and safety of a lidocaine and tetracaine (7%/7%) cream for induction of local dermal anesthesia for facial soft tissue augmentation with hyaluronic Acid. [2020]

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

A Multicenter Noninferiority Study Comparing Safety and Effectiveness of Hyaluronic Acid Fillers for Correction of Nasolabial Folds in Chinese Subjects. [2023]

5. 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]

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

Open-Label, Post-Marketing Study to Evaluate the Performance and Safety of Calcium Hydroxylapatite With Integral Lidocaine to Correct Facial Volume Loss [2019]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Hyaluronic acid dermal fillers: can adjunctive lidocaine improve patient satisfaction without decreasing efficacy or duration? [2022]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Safety and performance of cohesive polydensified matrix hyaluronic acid fillers with lidocaine in the clinical setting - an open-label, multicenter study. [2022]

9. England pubmed.ncbi.nlm.nih.gov

European evaluation of a new hyaluronic acid filler incorporating lidocaine. [2015]