Revanesse® Renew™+ for Wrinkles
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new skin treatment called Revanesse® Renew™+, which improves skin hydration and texture without adding volume. The researchers aim to determine whether receiving the treatment every two weeks or every month is more effective for enhancing skin appearance. Individuals interested in improving facial skin quality and who haven't had recent skin treatments might be suitable candidates for this study. As a Phase 4 trial, this research seeks to understand how this already FDA-approved and effective treatment can benefit more patients.
Will I have to stop taking my current medications?
The trial requires stopping certain medications that can prolong bleeding, like anticoagulants and NSAIDs, 14 days before the injection. If you're on hormonal therapy, you need to be on a stable dose for at least 3 months before the trial and not change it during the study.
What is the safety track record for Revanesse® Renew™+?
Research shows that Revanesse® Renew™+, a skin booster made from hyaluronic acid (HA), is generally safe and well-tolerated. HA fillers like Revanesse® Renew™+ are safe for use in the body. These clear gels are injected under the skin to smooth wrinkles and improve skin texture. Some studies have found that swelling at the injection site can occur later, but this is a known issue with all dermal fillers.
For those considering joining a clinical trial, it's important to know that Revanesse® Renew™+ has undergone previous testing. While this specific version is currently under study, similar HA products have not shown major safety concerns in past studies. Always consult a healthcare provider to understand any potential risks and benefits.12345Why are researchers enthusiastic about this study treatment?
Revanesse® Renew™+ is unique because it uses a specially formulated hyaluronic acid to target wrinkles. Unlike other wrinkle treatments that often involve more invasive procedures, Revanesse® Renew™+ offers a non-surgical option with fewer side effects. Researchers are excited about its potential for quicker and more consistent results, thanks to its advanced gel technology that allows for smoother, longer-lasting outcomes. This treatment's flexibility, with options for biweekly or monthly administration, also adds to its appeal, offering tailored approaches to meet individual needs.
What is the effectiveness track record for Revanesse® Renew™+ in treating wrinkles?
Research has shown that Revanesse® Renew™+ improves skin hydration and texture. This trial will compare two treatment schedules for Revanesse® Renew™+. Participants in Group A will receive biweekly treatments, while those in Group B will receive monthly treatments. The treatment uses two types of hyaluronic acid (HA), a substance that naturally attracts and holds water in the skin. Studies have found that HA injections can increase skin moisture and reduce wrinkles, making the skin smoother and more flexible. Revanesse treatments also tend to cause less swelling than other similar products. Overall, evidence supports that Revanesse® Renew™+ helps maintain skin moisture and improves skin quality without adding volume.678910
Who Is on the Research Team?
Andreas Nikolis, MD, PhD
Principal Investigator
Erevna Innovations Inc.
Are You a Good Fit for This Trial?
This trial is for immune-competent adults over 30 who want to improve their facial skin quality. Participants must understand the study, consent to it, and follow pre-visit instructions like shaving. Women of childbearing age must use effective birth control and take pregnancy tests.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Revanesse® Renew™+ injections either biweekly or monthly for a total of three treatments
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Revanesse® Renew™+
Trial Overview
The study tests Revanesse® Renew™+, a dual-weight hyaluronic acid gel injected into the skin to hydrate and refine texture without adding volume. It compares treatment schedules (biweekly vs monthly) for effectiveness in enhancing facial aesthetics.
How Is the Trial Designed?
2
Treatment groups
Active Control
Participants randomized to Group 1 : Biweekly Treatment, will undergo three treatments with Revanesse (R) Renew(TM)+ spaced 2 weeks apart.
Participants randomized to Group 2: Monthly Treatment, will undergo three treatments with Revanesse (R) Renew(TM)+ spaced 4 weeks apart.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Erevna Innovations Inc.
Lead Sponsor
Citations
SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED)
The purpose of the study was to compare the safety and effectiveness profiles of Revanesse® Lips+ to an approved dermal filler. Comparator, for subjects seeking ...
Multicenter Double-Blind Randomized Split-Face Study to ...
The study was a randomized, double-blind prospective, comparative study of the efficacy and safety of Revanesse Ultra versus the approved product Restylane in ...
3.
oasismedcenter.com
oasismedcenter.com/how-long-does-revanesse-versa-last-discover-lasting-results-and-amazing-benefits/How Long Does Revanesse Versa Last? Discover ...
Revanesse Versa is a popular dermal filler that can last between six to twelve months. This time can vary based on different factors.
Clinical evaluation of a cross-linked hyaluronic Acid dermal ...
Conclusion: Good - excellent volume enhancement was noted almost immediately after the HA injections, improving patient reported quality of life aspects. HA ...
Revanesse® Ultra™+
In one of our clinical trials, 51% more patients treated with a comparable product experienced swelling versus patients who were treated with Revanesse® Ultra™+ ...
Rest of the World
Revanesse® Pure™+ is a Health Canada approved hyaluronic acid gel that is indicated for the treatment of facial rhytides and lipoatrophy by injection into the ...
SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED)
Revanesse Ultra contains trace amounts of gram positive bacterial proteins, and is contraindicated for patients with a history of allergies to such material. Do ...
Revanesse® Renew™+
Hyaluronic acid fillers are body-safe clear gels that, when injected beneath the skin, can help to fill in facial wrinkles, restore volume loss, and refine your ...
Revanesse IFU | Instructions For Use
Important Safety Information. Delayed-onset inflammation near the site of dermal filler injections is one of the known adverse events associated with dermal ...
revanesse ultra patient information sheet - accessdata.fda.gov
The study did not demonstrate any safety concerns with retreatment of Revanesse Ultra for men or women at least 22 years of age with nasolabial ...
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