HArmonyCa Injectable Gel for Midface Volume Loss

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new injectable gel, HArmonyCa Lidocaine, to evaluate its effectiveness and safety in treating midface volume loss. The gel aims to restore facial volume and improve skin appearance affected by aging and environmental factors. Participants will be divided into two groups, with some receiving the gel treatment immediately and others starting later. Individuals in good health seeking to enhance their midface area might be suitable for this trial. As a Phase 3 trial, this study 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. 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 prior data suggests that this injectable gel is safe for midface volume loss?

Research shows that HArmonyCa Lidocaine Injectable Gel is being tested for safety and effectiveness in adding volume to the midface. Previous studies have examined side effects and treatment efficacy. Although long-term safety data remains limited, HArmonyCa combines hyaluronic acid (naturally found in the skin) with calcium hydroxyapatite (a mineral providing structure) to create a hybrid dermal filler.

Earlier research indicates that people using similar treatments generally tolerate them well, with only mild side effects reported. Common side effects might include redness, swelling, or bruising at the injection site, typical for dermal fillers. The study's advanced phase suggests that earlier tests have shown a reasonable safety profile. However, participants should discuss potential risks with their healthcare provider before joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

HArmonyCa Lidocaine Injectable Gel is unique because it combines lidocaine, a local anesthetic, with a gel filler to restore midface volume, potentially providing both immediate and long-lasting results. Unlike traditional dermal fillers that only add volume, this gel is designed to integrate more naturally with facial tissues, offering a smoother, more natural-looking enhancement. Researchers are excited about this treatment because it not only fills but also helps rejuvenate the skin through its unique formulation, potentially reducing the need for frequent touch-ups compared to existing fillers.

What evidence suggests that this device is effective for midface volume loss?

Research shows that HArmonyCa Lidocaine Injectable Gel is designed to enhance the mid-face's appearance by adding volume. This gel contains two main ingredients: hyaluronic acid, which helps the skin retain moisture, and calcium hydroxyapatite, which stimulates collagen production. Early results suggest this combination not only provides immediate volume but also enhances the skin over time by increasing collagen, a protein that maintains skin firmness. Previous studies have shown that similar products can effectively add volume to the face, creating a more youthful appearance. While specific data from HArmonyCa studies is still being gathered, the gel is based on methods proven effective in other treatments. Participants in this trial will receive HArmonyCa Lidocaine Injectable Gel, while a control group will be observed for 3 months before having the option to receive the gel. ^{1 4 6 7 8}

Who Is on the Research Team?

ALLERGAN INC.

Principal Investigator

Allergan

Are You a Good Fit for This Trial?

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

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

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.

Has fat injection or permanent facial implants (eg, polymethylmethacrylate, silicone, polytetrafluoroethylene) anywhere in the face

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07032597?lead=AbbVie&rank=5

A Study to Assess Safety and Effectiveness of HArmonyCa ... The purpose of this study is to assess adverse events and effectiveness of HArmonyCa Lidocaine injectable gel compared to Restylane® Perlane® Lidocaine (Perlane) ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11412701/

A Novel Hybrid Injectable for Soft-tissue Augmentation HA/CaHa, a novel hybrid injectable containing CaHa microspheres suspended in an HA gel, is designed to immediately restore volume and increase ...

3. withpower.com withpower.com/trial/phase-3-mid-face-volume-deficit-6-2022-3e4a7

HArmonyCa Injectable Gel for Midface Volume Loss This trial tests a new facial filler gel called HArmonyCa Lidocaine to see if it safely and effectively improves mid-face appearance in adults.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05452070

NCT05452070 | A Study to Assess Adverse Events and ... The purpose of this study is to assess adverse events and effectiveness of HArmonyCa Lidocaine injectable gel in adults seeking mid face soft tissue ...

5. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=M21-784

M21-784 A study to assess adverse events and change in disease activity of HArmonyCa Lidocaine Injectable Gel for mid face soft tissue augmentation in adult ...

6. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=M21-782

A Study to Assess Safety and Effectiveness of HArmonyCa ... A Study to Assess Safety and Effectiveness of HArmonyCa Lidocaine Injectable Gel for Restoration and/or Creation of Mid-Face Volume in Adult Participants.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10860969/

A Retrospective Analysis of Safety in Participants Treated ... Limited long-term safety data are published on HA/CaHA/L, a hybrid dermal filler combining hyaluronic acid (HA), calcium hydroxyapatite ...

8. ctv.veeva.com ctv.veeva.com/study/a-study-to-assess-adverse-events-and-change-in-disease-activity-of-harmonyca-lidocaine-injectable-ge

A Study to Assess Adverse Events and Change in Disease ... The purpose of this study is to assess adverse events and effectiveness of HArmonyCa Lidocaine injectable gel in adults seeking mid face soft tissue ...