Renuvion for Loose Skin
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to assess the Renuvion device's effects on skin quality by improving elasticity and hydration. It also estimates the biological age of the skin using DNA methylation. Participants will receive a lower facelift along with Renuvion treatment. This trial suits individuals planning a lower facelift, who are generally healthy and have not undergone previous facelift or neck lift procedures. As an unphased trial, it offers participants the opportunity to contribute to innovative research in skin rejuvenation.
Do I need to stop my current medications for the Renuvion trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss your specific medications with the study team to get a clear answer.
What prior data suggests that the Renuvion device is safe for use in lower facelift procedures?
Research has shown that the Renuvion APR System, which uses helium plasma energy, is generally safe for improving skin appearance. In studies focused on loose skin around the neck, no serious side effects were linked to the device or the procedure, indicating that most patients tolerate the treatment well.
However, some risks exist. For example, helium could accidentally enter the surgical area, a condition known as helium embolism. These risks are rare and usually well-managed by doctors.
The Renuvion device has FDA clearance for certain cosmetic procedures, supporting its safety when used correctly. Overall, evidence indicates that this treatment is safe, with manageable risks.12345Why are researchers excited about this trial?
Renuvion APR System is unique because it uses a combination of helium plasma and radiofrequency energy to tighten loose skin, particularly in the lower facelift area. Unlike traditional facelift surgeries that rely solely on surgical excision and repositioning of skin, Renuvion offers a minimally invasive approach, potentially leading to quicker recovery times and reduced scarring. Researchers are excited about this treatment because it promises precise targeting of the skin’s deeper layers, enhancing skin tightening and rejuvenation with less downtime than conventional surgical methods.
What evidence suggests that the Renuvion device is effective for improving skin elasticity and hydration?
Research has shown that the Renuvion APR System effectively tightens loose skin. In one study, patients experienced an average reduction in skin surface area of 22% after one month and 17% after three months. Another study found a 26% average improvement in skin tightness. Patients generally reported less loose skin and expressed high satisfaction with the results. In this trial, participants will undergo a procedure with the Renuvion APR System in the lower facelift area. These findings suggest that Renuvion can enhance skin quality and tightness without increasing complications.15678
Who Is on the Research Team?
Melinda Lacerna, M.D.
Principal Investigator
LA Plastic Surgery & Dermatology
David Holcomb, M.D.
Principal Investigator
Holcomb & Kreithen Plastic Surgery and MedSpa
Are You a Good Fit for This Trial?
This trial is for men and women aged 18-75 planning to have a lower facelift surgery. It's designed to assess the effects of the Renuvion APR System on skin quality, specifically elasticity and hydration, as well as estimating biological skin age.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a lower facelift surgery and treatment with the Renuvion APR System
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of skin elasticity, hydration, and biological age estimation
What Are the Treatments Tested in This Trial?
Interventions
- Renuvion APR System
Find a Clinic Near You
Who Is Running the Clinical Trial?
Apyx Medical
Lead Sponsor