30 Participants Needed

Hyaluronic Acid Filler for Cosmetic Improvement

LR
Overseen ByLaura Raco
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to using hyaluronic acid (HA) fillers for cosmetic facial improvements. The focus is on achieving a balanced and complete look by layering HA fillers from the Restylane line to address hollowness or sagging in various facial areas. This method suits individuals noticing significant volume loss or sagging in the midface or lower face, such as the chin or lips. Participants should be in good health, with no recent facial surgeries or filler treatments, and no conditions affecting their skin or nerves. As an unphased trial, this study allows participants to explore innovative cosmetic solutions before they become widely available.

Will I have to stop taking my current medications?

The trial requires participants to stop taking over-the-counter NSAIDs (like Advil) at least two weeks before treatment. Participants must also not take immunosuppressants or have bleeding disorders that require thrombolytics or anticoagulants.

What prior data suggests that this pan-facial layering technique is safe?

Research has shown that Restylane injectables, a type of hyaluronic acid (HA) filler, are generally safe. The FDA has approved Restylane, and it has been used for over 20 years, demonstrating its safety.

Studies have found that some common side effects can occur, including swelling, pain, redness, and bruising at the injection site. Less common effects might include lumps, firmness, and itching. These side effects are usually mild and resolve on their own.

Overall, patients have tolerated Restylane products well. Its long history of use and approval for different facial areas supports its safety. However, individuals with severe allergies or specific sensitivities should avoid these fillers.12345

Why are researchers excited about this trial?

Most treatments for facial volume loss and cosmetic improvement, like traditional fillers, focus on adding volume to specific areas. But the hyaluronic acid filler used here, Restylane Injectables, is applied using a technique called pan-facial layering. This approach targets multiple layers and areas of the face simultaneously, addressing both midface and lower face deficits. Researchers are excited about this technique because it could offer a more balanced and natural-looking rejuvenation, potentially enhancing the overall symmetry and youthfulness of the face compared to other fillers that typically focus on isolated regions.

What evidence suggests that pan-facial layering of hyaluronic acid filler is effective for cosmetic improvement?

Studies have shown that hyaluronic acid fillers, like those in the Restylane line, effectively improve facial features. In this trial, participants will receive Restylane injectables to address primary deficits in either the midface or lower face. Research indicates that Restylane Defyne is safe and significantly enhances the chin's appearance. One study found that these fillers can reduce signs of aging, such as loss of volume in the midface and a receding chin. Notably, over 94% of people and doctors observed visible improvements after using Restylane, with effects lasting up to a year. This makes Restylane a reliable choice for enhancing facial features.25678

Who Is on the Research Team?

AN

Andreas Nikolis, MD

Principal Investigator

Erevan Innovations Inc.

Are You a Good Fit for This Trial?

This trial is for individuals seeking cosmetic enhancement with facial aesthetic concerns. It's designed for those who could benefit from a tailored approach using hyaluronic acid fillers, specifically the Restylane products. The eligibility criteria are not fully detailed here.

Inclusion Criteria

Participants must voluntarily sign and date an informed consent, approved by an independent ethics committee, prior to the initiation of any screening or study-specific procedures
Participants must be willing and able to comply with procedures required in the protocol
Participants must be in good health as per investigator's judgment based on medical history
See 20 more

Exclusion Criteria

I have not had an active COVID infection in the last 14 days.
I have had cystic acne in the past.
I have scheduled dental work around my treatment dates.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pan-facial, multilayering treatment with hyaluronic acid fillers

24 weeks
Multiple visits as required for treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Pan-Facial Layering of Hyaluronic Acid Filler
Trial Overview The study tests a new method of layering different types of Restylane HA fillers across the face to achieve personalized, harmonious aesthetic results. It aims to assess both the effectiveness and safety of this pan-facial multilayering technique.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Restylane InjectablesExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Erevna Innovations Inc.

Lead Sponsor

Trials
13
Recruited
340+

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 ...
Effectiveness, safety, and versatility of hyaluronic acid ...The results of this case series indicate that injections of HA filler reduced multiple signs of aging, including reduced midface volume, chin retrusion, and/or ...
3.restylaneusa.comrestylaneusa.com/
Restylane® | Award Winning HA Dermal Filler PortfolioRestylane is the original aesthetic hyaluronic acid (HA) filler, with the most diverse range of fillers to help you achieve any and every look.
Galderma receives U.S. FDA approval for Restylane® Lyft ...At Month 3, 99.1% of investigators and 94.4% of subjects reported visible improvement. These results were maintained at Month 12, with 95.5% of ...
Hyaluronic Acid Filler VYC-25L for Jawline Restoration Yields ...At Month 12, 68% of treated participants in this study were still satisfied with VYC-25L treatment and 87% would recommend VYC-25L treatment for ...
Injectable Dermal Filler Device Trade Name: Restylane® InjeReport of the global aesthetic improvement score favoring Resty1ane increased over time following treatment. This trend was similar for data by evaluating ...
Adverse Events Reported From Hyaluronic Acid Dermal Filler ...The adverse events were swelling, pain, erythema, bruising, lumps and bumps, firmness, tenderness, itching, and skin discoloration.
Restylane: Uses, Dosage, Side EffectsRestylane is a FDA-approved dermal filler made of a biodegradable, non-animal stabilized hyaluronic acid (NASHA). Hyaluronic acid is a natural ...
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