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Dermal Filler
Hyaluronic Acid Fillers for Facial Volume Loss (RES Trial)
N/A
Waitlist Available
Led By Steven F Weiner, MD
Research Sponsored by Galderma R&D
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 4 weeks, 6 months, 9 months, and 12 months after baseline
Awards & highlights
RES Trial Summary
This trial looked at how well two types of Hyaluronic Acid fillers show up on ultrasound imaging.
Who is the study for?
This trial is for individuals who can consent to participate, will follow the study's procedures, and have midface volume loss. It excludes those with previous permanent facial implants, recent facial treatments in the last 6 months that could affect results, or allergies to lidocaine and hyaluronic acid.Check my eligibility
What is being tested?
The study aims to compare how two different Hyaluronic Acid dermal fillers – Restylane Contour and Juvederm Voluma – accumulate in tissue when observed under ultrasound after being injected into participants' midfaces.See study design
What are the potential side effects?
While not explicitly listed here, common side effects of dermal fillers include swelling, redness at injection sites, bruising, pain or tenderness. Rarely they may cause allergic reactions or lumpiness.
RES Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ immediately post-treatment, 4 weeks, 6 months, 9 months, and 12 months after baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately post-treatment, 4 weeks, 6 months, 9 months, and 12 months after baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assess and compare tissue aggregation and visualization of Hyaluronic Acid fillers using ultrasound
Secondary outcome measures
Evaluate subject satisfaction using self-assessment questionnaire
Evaluate volume change in the treated areas using 3D imaging
RES Trial Design
2Treatment groups
Active Control
Group I: Juvederm VolumaActive Control1 Intervention
Form: sterile, biodegradable, non-pyrogenic, viscoelastic, clear, colorless, homogenous gel implant of Hyaluronic Acid crosslinked with BDDE, formulated with lidocaine.
Mode of administration: injection Dosage: at investigator's discretion for optimal outcome. Frequency and duration: injection at baseline and optional touch-up at week 4.
Group II: Restylane ContourActive Control1 Intervention
Form: transparent gel of Hyaluronic Acid with the addition of lidocaine hydrochloride.
Mode of administration: injection Dosage: at investigator's discretion for optimal outcome. Frequency and duration: injection at baseline and optional touch-up at week 4.
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Who is running the clinical trial?
Galderma R&DLead Sponsor
300 Previous Clinical Trials
60,466 Total Patients Enrolled
Steven F Weiner, MDPrincipal InvestigatorThe Aesthetic Clinique
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have lost volume in the middle of your face and your face's shape is not as defined.You are allergic to lidocaine or injectable hyaluronic acid.You have received a tissue augmentation treatment in the area that will be treated in the past year before the start of the study.
Research Study Groups:
This trial has the following groups:- Group 1: Juvederm Voluma
- Group 2: Restylane Contour
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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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