New-generation filler based on cross-linked carboxymethylcellulose: study of 350 patients with 3-year follow-up.

PURPOSE: In recent years there has been a growing interest in nonsurgical procedures for facial rejuvenation. Hyaluronic acid is currently the most widely used dermal filler for the treatment of facial wrinkles. However, new products with interesting features are being introduced into the market. Cross-linked carboxymethylcellulose is one of these and represents a new alternative for the correction of wrinkles and facial defects. PATIENTS AND METHODS: The retrospective, multicenter, open-label study on nasolabial folds reported here was carried out between January 2010 and April 2014 on 350 subjects between 22 and 67 years of age for a 36-month follow-up period in order to consistently and extensively assess the safety and performance of this treatment. RESULTS: The study revealed effective and durable correction of nasolabial wrinkles for periods of 9-12 months. Product reapplication over a 36-month period did not lead to an increase in adverse effects, which always remained rare and of little clinical significance, usually consisting of bruising and redness. CONCLUSION: Cross-linked carboxymethyl cellulose has been shown to be a safe and effective alternative to the resorbable products currently on the market.

Facial tightening with an advanced 4-MHz monopolar radiofrequency device.

BACKGROUND: Over the past 10 years, radiofrequency (RF) technology has been utilized for nonablative treatments for the treatment of rhytides and skin laxity. This manuscript reviews the scientific background of collagen synthesis in vivo and in response to RF energy as well as a clinical study of 17 patients receiving a series of facial treatments with a 4-MHz monopolar RF (Pellevé, Ellman International, Inc, Oceanside, NY). Clinical methods, results, and a review of the literature for RF aesthetic treatments of the face are presented. METHODS: Seventeen patients were treated in one site with 6 total treatments scheduled as follows: 1 session was performed every 15 days for 2 consecutive sessions, 1 session every month for 2 consecutive sessions, and 1 session every 2 months for 2 consecutive sessions. Both the treating physician and the patients via live viewing and comparison with baseline photographs performed assessment of results. Results are reported as averages across the 17 patients. RESULTS: Two weeks after the first treatment, patients noted an overall average of 25% to 30% improvement. Just before the last or sixth treatment, there was an average of 50% improvement noted by the physician, with patients ranking an average self-improvement of 48%. The treating physician rated average improvement of 46% compared with baseline, whereas the patients ranked average improvement of 30% compared with baseline at 1 year after treatment was initiated (6 months after the final treatment). Patients find this treatment to be very well tolerated, with minimal to no discomfort and no downtime or significant side effects. CONCLUSIONS: The Pellevé 4-MHz monopolar RF device is effective, safe, and very well tolerated for treating laxity, texture, and wrinkles of the skin without complication or discomfort. Evidence in the literature supports the scientific mechanism of action of acute collagen modification and continued neocollagenesis observed with the system. In this cohort, patients maintain approximately 50% improvement on average at 6 months and a 30% to 50% improvement 1 year after beginning the treatments, 6 months after completion.

Use of cross-linked carboxymethyl cellulose for soft-tissue augmentation: preliminary clinical studies.

PURPOSE: The continual search for new products for soft-tissue augmentation has in recent years led to the introduction of long lasting alternatives to hyaluronic acids and collagen that are composed of other polymers able to improve clinical persistence over time. This is the first report in which sodium carboxymethyl cellulose (CMC) has been chemically treated by the cross-linking process and thus used as a hydrogel for soft-tissue augmentation through injection with thin needles. The study evaluates, from a clinical point of view, the behavior of cross-linked carboxymethyl cellulose hydrogel used in the aesthetic field and its side effects so as to check the safety and performance of the polymer following intradermal injections. PATIENTS AND METHODS: This work shows the preliminary results of an ongoing clinical study conducted between 2006 and 2009, performed on 84 healthy volunteers (62 females, 22 males) aged between 18 and 72 years, for the treatment of 168 nasolabial folds, 45 perioral wrinkles, and 39 lip volume. RESULTS: Study results show an excellent correction of facial defects. Tolerance and aesthetic quality of the correction obtained indicate considerable safety features and absence of side effects. From a clinical point of view, hydrogel is gradually absorbed into the injection site without migration issues. CONCLUSION: Cross-linked CMC hydrogel proves to be an ideal agent for soft tissue augmentation with regard to safety and ease of application. It did not cause infection, extrusion, migration, or adverse reactions in the patients who have been followed for two years. Delayed aesthetic results on facial wrinkles were very satisfactory.