Journal
Sagging neck and under-chin: what did the Renuvion clinical trial show?
Articles by Dr. Oh
In 2022, Renuvion received FDA clearance in the US for improving loose skin in the neck and under the chin. In the clinical trial behind that clearance, 82.5% of 65 patients were rated as improved at 6 months.
The neck and the area under the chin are among the first places where age shows. Clothes don’t cover them, and when the border between the jawline and the neck blurs in profile or in photos, you can look older than you are. Can this area be tightened without an incision? The Renuvion clinical trial on the neck and under the chin set out to answer that question.
Published in 2023 in Aesthetic Surgery Journal, this was a clinical trial carried out at several centers in the US. A total of 65 people aged 35 to 65 who wanted to reduce loose skin in the neck and under the chin had Renuvion and were followed for 6 months. Their average age was 55.9.
To assess results, photos taken before and 6 months after treatment were shown in mixed order, and the measure was the share of patients for whom at least 2 of 3 reviewers, who didn’t know which photo was taken after treatment, judged there to be improvement. The result was 82.5%. Among the patients themselves, 85.5% said their skin had improved, and 74.2% said they would recommend it to someone they know.
Safety was assessed by pain after treatment. By day 7, 96.9% had no pain or no more than moderate pain, and there were no serious adverse events related to the device or the treatment. Based on these results, Renuvion received FDA 510(k) clearance in the US in July 2022 for improving the appearance of loose skin in the neck and under the chin.
Side effects were also reported. The most common were temporary motor nerve weakness (6.2%), itching (6.2%) and hematoma (4.6%). The nerve that moves the muscles around the mouth runs through the neck and under the chin, so if it is temporarily weakened, the corner of the mouth may move less when you smile. In the study, all of these cases resolved on their own, but it’s something you need to know before treatment. Firmness in the treated area lasting for a while (induration) was also reported.
There are points to keep in mind when reading this study. There was no control group, as everyone in it received the treatment, and most participants were Western. If there is so much excess skin that it folds, a surgical lift with incisions may be the better fit. The approach also depends on whether the sagging under the chin comes from fat or from loose skin. If there is a lot of fat, we remove it with facial liposuction, and if the skin is loose, we add Renuvion.
References
Ruff PG, Bharti G, Hunstad J, et al. Safety and Efficacy of Renuvion Helium Plasma to Improve the Appearance of Loose Skin in the Neck and Submental Region. Aesthet Surg J, 2023. doi:10.1093/asj/sjad055
Translated from Dr. Oh’s original article in Korean. Read the Korean original