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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 25 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 25 months
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 moreTrial 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.
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.
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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
Eligibility Criteria:
This trial includes the following eligibility 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.I currently have an eye infection or inflammation.I have had facial treatments like laser or peels in the last 6 months.I have not had botulinum toxin in my cheek or crow's feet area in the last 6 months.I am looking to get my mid-face area enhanced.I can sign and follow the study's consent form and rules.I am allergic to certain medications used in this study or similar ones.I have had facial filler injections in the last 2 years.I can and will follow the study's rules and visit schedule.I have not had major dental work in the last 6 weeks and don't plan any during the study.I haven't had any live vaccines in the last 4 weeks and don't plan to during the study.I am willing to remove any facial hair, piercings, or cover tattoos for assessments.
Research Study Groups:
This trial has the following groups:- Group 1: HArmonyCa Lidocaine Injectable Gel
- Group 2: Control Group
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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