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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

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 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

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.

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.

Find a Location

Who is running the clinical trial?

AllerganLead Sponsor
781 Previous Clinical Trials
276,483 Total Patients Enrolled
ALLERGAN INC.Study DirectorAllergan
75 Previous Clinical Trials
79,373 Total Patients Enrolled

Media Library

HArmonyCa Lidocaine Injectable Gel (Soft Tissue Filler) Clinical Trial Eligibility Overview. Trial Name: NCT05452070 — Phase 3
Midface Volume Loss Research Study Groups: HArmonyCa Lidocaine Injectable Gel, Control Group
Midface Volume Loss Clinical Trial 2023: HArmonyCa Lidocaine Injectable Gel Highlights & Side Effects. Trial Name: NCT05452070 — Phase 3
HArmonyCa Lidocaine Injectable Gel (Soft Tissue Filler) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05452070 — Phase 3
~37 spots leftby May 2025