What side effects are associated with this type of intervention?

Common treatments for midface volume loss include hyaluronic acid-based dermal fillers and calcium hydroxylapatite fillers. The known side effects of these treatments are generally mild and transient, including pain, bruising, edema, and erythema at the injection site. Rarely, patients may experience delayed hypersensitivity reactions, granulomatous reactions, or noninflammatory nodules. Serious complications such as bacterial infections, vascular occlusion, or tissue necrosis are uncommon. The inclusion of lidocaine in these fillers helps reduce discomfort during the procedure without affecting the efficacy of the treatment.

What prior FDA approvals exist?

The FDA has approved several dermal fillers for the treatment of midface volume loss, similar to the investigational HArmonyCa Lidocaine Injectable Gel. Notable examples include hyaluronic acid-based fillers like Juvéderm and Restylane, which are commonly used for facial soft tissue augmentation. Additionally, calcium hydroxylapatite (Radiesse) and poly-L-lactic acid (Sculptra) have been approved for similar indications. These treatments are designed to restore facial volume, improve contour deficiencies, and reduce the appearance of wrinkles, providing a non-surgical option for facial rejuvenation.

What other types of research exist?

Promising, novel alternatives to HArmonyCa Lidocaine Injectable Gel for midface volume loss include Neuramis Volume Lidocaine (SHAPE-NVL) and Juvederm Voluma with Lidocaine (VYC-20L). Both have demonstrated efficacy and safety in clinical studies for midface volume restoration.

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Soft Tissue Filler

HArmonyCa Injectable Gel for Midface Volume Loss

Phase 3

Waitlist Available

Research Sponsored by Allergan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 25 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include reactions at the injection site such as redness, swelling, pain or bruising; allergic responses due to ingredients like lidocaine; and possibly more general symptoms like headache or nausea.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 25 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 25 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 25 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants with Adverse Events

Face

Secondary study objectives

Change from baseline on overall score in FACE-Q Satisfaction with appearance specific questionnaire

Change from baseline on overall score in FACE-Q Satisfaction with cheeks specific questionnaire

Change from baseline on overall score in FACE-Q Satisfaction with lower face and jawline specific questionnaire

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: HArmonyCa Lidocaine Injectable GelExperimental Treatment1 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 GroupExperimental Treatment1 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.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Dermal fillers, such as HArmonyCa Lidocaine Injectable Gel, work by injecting substances like hyaluronic acid or calcium hydroxylapatite into the midface area to restore lost volume, smooth out wrinkles, and improve skin texture. These fillers provide immediate volume and stimulate collagen production, which enhances skin elasticity and firmness over time. This is crucial for patients with midface volume loss as it not only addresses aesthetic concerns but also improves facial symmetry and structural support, leading to a more youthful and balanced appearance.

Myomodulation with Injectable Fillers: An Innovative Approach to Addressing Facial Muscle Movement.A multicenter, randomized, double-blind comparison of two hyaluronic acid fillers in mid-face volume restoration in Asians: A 2-year extension study.Myomodulation with Injectable Fillers: An Innovative Approach to Addressing Facial Muscle Movement.