Hyaluronic Acid Fillers for Wrinkles
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two types of hyaluronic acid fillers, Defyne and RHA3, to evaluate their effectiveness in reducing moderate-to-severe nasolabial folds, the wrinkles around the mouth. Participants receive one type of filler on one side of their face and a different one on the other side to compare results. The goal is to determine which filler better smooths these wrinkles over time. Individuals with noticeable wrinkles in this area, who are generally in good health and have not undergone recent facial procedures, may be suitable for this study. As an unphased trial, it offers participants the chance to contribute to valuable research that could improve cosmetic treatment options.
Do I need to stop taking my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications. However, you cannot take anticoagulants (blood thinners) or certain supplements like omega 3 or vitamin E within 14 days before treatment, unless they are part of a standard multivitamin.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that both Defyne and RHA3, the treatments in this trial, are generally safe for people.
Studies have found that Defyne is usually well-tolerated, though some individuals might experience mild side effects. These can include small lumps, tenderness, swelling, and bruising at the injection site. Such reactions are common for fillers like Defyne and often resolve on their own.
RHA3 also has a good safety record. Research indicates it is effective and well-tolerated for treating moderate-to-severe lines from the nose to the mouth corners. No major safety issues have been reported, suggesting it is safe to use.
Both treatments are hyaluronic acid fillers, a type of gel often used in cosmetic procedures to add volume and smooth out wrinkles. Extensive studies have deemed them safe for most people. However, discussing any allergies or health conditions with the trial team is important to ensure these treatments are suitable.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Defyne and RHA3 for treating wrinkles because they offer innovative approaches to smoothing nasolabial folds. Unlike traditional options like Botox or other hyaluronic acid fillers, both Defyne and RHA3 are formulated to provide more natural-looking results by allowing for greater flexibility and movement in the skin. This means that while they help reduce wrinkles, they also maintain facial expressions, which is a significant advantage over some current treatments. Additionally, their unique cross-linking technology enhances the durability of the filler, potentially offering longer-lasting results.
What evidence suggests that this trial's treatments could be effective for wrinkles?
This trial will compare two treatments: Defyne and RHA3. Research has shown that Restylane Defyne effectively improves chin appearance, with 98% of patients noticing a better chin profile. Additionally, 83% of users reported feeling younger and more attractive. Meanwhile, studies have proven that RHA3 effectively reduces deep lines from the nose to the mouth, known as nasolabial folds. These studies also confirmed that RHA3 is safe and lasts for up to 15 months. Both treatments have demonstrated significant improvements in reducing wrinkles, making them promising options for addressing facial wrinkles.26789
Who Is on the Research Team?
Steven Weiner, MD
Principal Investigator
The Aesthetic Clinique
Are You a Good Fit for This Trial?
This trial is for adults aged 22-65 with moderate-to-severe nasolabial fold wrinkles. Candidates must be in good health, not pregnant or breastfeeding, and willing to avoid other facial procedures during the study. Smokers and those with allergies to lidocaine or HA fillers are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Initial treatment with Defyne on one NLF and RHA3 on the other, based on randomization
Touch-up
Optional touch-up treatment on one or both sides at the Investigator's discretion
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Defyne
- RHA3
Trial Overview
The study compares two hyaluronic acid fillers: Defyne and RHA3 for correcting nasolabial folds. Participants will receive both treatments on different sides of their face randomly and have follow-ups at months 3, 6, and 12 after initial treatment.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Defyne will be injected into the left or right nasolabial fold, per randomization.
RHA3 will be injected into the left or right nasolabial fold, per randomization.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Galderma R&D
Lead Sponsor
Flemming Ørnskov
Galderma R&D
Chief Executive Officer since 2019
MD, MPH
Baldo Scassellati Sforzolini
Galderma R&D
Chief Medical Officer
MD, PhD
Citations
A Randomized Trial to Assess Effectiveness and Safety of ...
Conclusions: The hyaluronic acid filler Restylane Defyne was safe and effective for augmentation of the chin region to improve the chin profile and associated ...
A Randomized, Controlled, Evaluator-Blinded Study - PMC
These results demonstrated HA DEF to be effective and safe for the correction of mild-to-moderate chin retrusion in Chinese subjects.
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galderma.com
galderma.com/us/news/galderma-presents-results-phase-4-clinical-studies-restylane-refyne-and-restylane-defyneGalderma Presents Results from Phase 4 Clinical Studies ...
** Results found that 83% (25/30) of subjects had enhanced attractiveness, looked younger and maintained naturalness. These data demonstrated ...
SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED)
At the Week 48 visit, 58.6% (58/99) of subjects in the Restylane Defyne group received re-treatment and 85.2% (23/27) of subjects in the no-treatment group ...
Restylane® Defyne for Chin and Laugh Lines
Restylane Defyne can correct mild-to-moderate chin retrusion, with 98% of patients having improved double chin appearance after treatment.
Adverse Events Reported From Hyaluronic Acid Dermal Filler ...
The most common complications reported were lumpiness, tenderness, swelling, and bruising. Another meta-analysis investigated the effectiveness ...
Safety and efficacy of hyaluronic acid injectable filler in the ...
This study investigated the efficacy and safety of the commercially available HA filler from Maxigen Biotech Inc. (MBI-FD) in the treatment of nasolabial folds ...
Safety and Efficacy Assessment of a Cross‐linked ...
Hyaluronic acid fillers are widely used to correct nasolabial folds. This treatment provides favorable aesthetic outcomes. The aim of this study ...
Pivotal Study to Evaluate the Efficacy and Safety of ...
Aim: The aim of this study was to demonstrate the efficacy and safety of a new HA filler (LASBEAU Strong) (24 mg/mL) compared with a conventional HA filler ( ...
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