Microneedling RF Device Helps Skin Appearance

A study (NCT03078647) published in Lasers in Surgery and Medicine investigated how effective a microneedling radiofrequency (RF) device, the Profound System (Candela) was in improving the aesthetic appearance of skin laxity and fat deposits above the knee, upper arms, and upper-mid back region.¹

The study enrolled 31 female patients with Fitzpatrick skin types I-IV that underwent a single dermal or subcutaneous treatment with 1-, 3-, and 6-month follow ups using the 5-point Likert scale for global esthetic improvement, skin laxity improvement, and satisfaction. If patients were pregnant, had systemic disorders, or a history of severe edema they were excluded from the study. 

The patients received single RF microneedling treatments in 62 areas: 22 in the upper arm, 34 in the suprapatellar, and 6 in the bra line. Investigators measured pain using a numerical scale, with 0=no pain to 10=worst pain possible. Out of the 31 patients, 17 were treated on the suprapatellar area, 11 on the upper arms, 3 on the bra-line area. 

“One study investigator (M.A.) treated each contralateral side with the same treatment parameters (i.e., handpiece, number of pulses), whereas the other study investigator (G.M.) treated each side differently,” the authors wrote.

A dermal cartridge, a subQ cartridge, or a combination of both were applied as pulses during treatment to a 15-20 mm area and then a second pass of the dermal was used. There was no patient to mild discomfort in 98% of the areas after most treatments. 

The adverse events (AEs) reported included transient erythema in 69% of patient treatments, edema in 46% both of which were resolved between 1 and 3 days. About 12% of patients after treatment experienced tingling that was resolved in usually less than 2 days and after 10% of treatments pin-point bleeding that resolved in the same day. There was also mild bruising after 32% of treatments those were resolved in about 1 to 2 days. No blistering scarring or pigmentary changes were reported. 

The improvement in appearance was reported for both left and right sides of the body with the same parameters, but the contralateral sides were treated with different parameters. The Global Aesthetic Improvement (GAI) for all areas was 80% at 1 month after treatment and 95% at 3 months, and the skin laxity followed similar trends with improvement at 90% at 1 month and 95 at 3 months. At the 6 month follow up, 68% of areas achieved at least 25% improvement and 27% of treatment areas achieved 75% or greater overall improvement. 

“Investigator satisfaction was 61%, 85%, and 73% at the 1-, 3-, and 6-month follow-ups, respectively,” the authors wrote.

The GAI assessment broken down by treatment area showed that 69% of the suprapatellar, 100% of upper arms, and 100% of bra-line area demonstrated improvement by month 1 follow up. By the 6 month follow up, 58% of the suprapatellar, 90% of upper arms, and 80% of bra-line area demonstrated greater than 25% improvement.

Skin laxity, by investigator assessment, there was a slightly visible to very visible improvement for 85% for the suprapatellar, 100% of the upper arm, and 100% of the bra line area at the 1 month follow up. This changed at the 6 month follow up, with 58%, 80%, and 80% of the areas showing visible or very visible improvement respectively. The investigator assessments of GAI and skin laxity showed greater improvement with subQ treatments vs dermal treatment at 6 months. 

Subject and investigator assessments were similar in overall improvement and there was a high patient satisfaction rate and willingness to recommend treatment to others.

"Treatment of body skin laxity and localized fat deposits has been a challenge,” said Macrene Alexiades, MD, PhD, associate clinical professor at Yale University School of Medicine, New Haven, Connecticut. “The advent of radiofrequency microneedling, a concept to which I have devoted much research over the past 15 years culminating in a new genre of technology, offered an opportunity to meet this challenge. The current successful application of this single non-surgical treatment to the upper arms, bra-line and above the knees offers a solution and is an important advance in our field.” ²

Reference:

1. Alexiades M, Munavalli GS. Single treatment protocol with microneedle fractional radiofrequency for treatment of body skin laxity and fat deposits. Lasers in Surgery and Medicine. Published March 25, 2021. Accessed June 23, 2021. doi:https://doi.org/10.1002/lsm.23397

2. Alstad A. Microneedle radiofrequency device shows promise for non-invasive skin tightening and body contouring in hard-to-treat areas. Published April 21, 2021. Accessed June 24, 2021. https://www.aslms.org/about-aslms/media-center/news/2021/04/21/microneedle-radiofrequency-device-shows-promise-for-non-invasive-skin-tightening-and-body-contouring-in-hard-to-treat-areas