Positive 90-Day Results from CONFORM Study: Recros Medica

May 30, 2019
Positive 90Day Results from CONFORM Study Recros Medica image

Ninety-day results from the CONFORM study assessing the efficacy, safety, and patient satisfaction of the Rotational Fractional Resection (RFR) procedure for submental contouring are promising. RFR is a novel, proprietary alternative to traditional approaches to treat skin laxity developed by Recros Medica, Inc. Hema Sundaram, MD, FAAD presented the study results at the 2019 American Society for Aesthetic Plastic Surgery (ASAPS) meeting. 

In the CONFORM study, adults with mild to moderate skin laxity and excess fat were treated to improve submental contouring. At baseline, 99% of subjects were dissatisfied with their neck and jawline appearance, while at 7-days after a single RFR procedure, 84% were now satisfied. Satisfaction with the appearance of the neck and jawline persisted and at the 90-day timepoint was 82% which represented a statistically significant change from baseline. In addition, 94% of patients at Day 90, indicated they were likely to recommend this procedure to friends and family.  

“The initial results we have seen from the CONFORM study are promising,” comments Dr. Sundaram. “In addition to presenting favorable safety and satisfaction profiles, RFR demonstrated visible improvements when assessed by independent, blinded physician evaluators not affiliated with the clinical trial. These physicians were able to identify 95% of Day 90 post-treatment images compared to baseline photographs. Digital image analysis performed by Canfield Scientific provided quantitative correlation with these blinded evaluations, indicating that 72% of treated patients had a significant reduction in measured surface area.”

The most common adverse events related to the RFR procedure included: bruising (16%), erythema (6%), contact dermatitis (6%), hypoesthesia (6%) and bleeding (4%) at the treatment site. The safety of RFR has been demonstrated by showing that there were no serious device- or procedure-related adverse events.

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