A Novel 3-Point Injection Technique for OnabotulinumtoxinA in the Upper Depressor Anguli Oris.

BACKGROUND AND OBJECTIVE: To evaluate the efficacy and safety of onabotulinumtoxinA (ONA) injections to the depressor anguli oris (DAO) to improve downturned mouth. PATIENTS AND METHODS/MATERIALS: This prospective, placebo-controlled, study enrolled subjects aged 18 to 65 years. Injections were performed using a novel 3-point technique in the upper DAO (1.5 U/injection site). The primary end point was a DAO contraction scale 1-grade improvement. Subjective evaluation was performed using the Global Aesthetic Improvement Scale (GAIS). RESULTS: Ten subjects received ONA and 10 placebo (saline) injections. In ONA-treated subjects, DAO scores showed significant improvements at Weeks 4 and 12 ( p < .001) compared with baseline. No significant difference between visits was observed for placebo-injected subjects. Global Aesthetic Improvement Scale scores showed that 100% of subjects were improved compared with baseline at Week 4% and 90% at Week 12. By contrast, 90% and 80% of placebo-treated subjects had "no change" in their DAO appearance at Weeks 4 and 12. Subject GAIS assessments matched the live evaluator at Week 4; 60% continued to report improvement at Week 12. Treatment was well tolerated. CONCLUSION: OnabotulinumtoxinA injections to the DAO using a 3-point technique provide clinically meaningful improvements in appearance. Treatment was well tolerated and in most individuals lasted at least 12 weeks. IDENTIFIER: ClinicalTrials.gov NCT04240535.

A Double-Blind Randomized Controlled Trial Evaluating the Efficacy and Tolerability of a Topical Body Treatment in Combination With Cryolipolysis Procedures

Background: Non-surgical fat reduction through cold application, cryolipolysis, is an extremely popular procedure. Apoptosis of the fat cell content may take around 3 months to resolve. Objective: A topical test product was compared to a bland emollient as an adjunct to the cryolipolysis procedure of the upper arms to determine if the product could hasten outcomes in these patients. The product includes a peptide combination thought to stimulate autophagic breakdown of lipid droplets, thus speeding up the apoptotic process seen after cryolipolysis. Methods: A randomized, double-blind, comparator-controlled study in 11 patients compared the test product to a bland emollient on the upper arms of patients following cryolipolysis. Subjects were followed at 1, 4, 8, 12, and some at 24-weeks post treatment. Assessments were made through subjective and objective photographic analysis of the treated areas comparing changes in both arms. Results: The test product appeared to speed up the process of contour improvement with results at 8 weeks matching those attained at 12 weeks by the comparator and long-term results at 24 weeks appearing to maintain this advantage. When measured objectively using pixel analysis, 8 and 24-week contour improvement was statistically better than the comparator. Skin laxity was also improved. In additional assessments using 3D volume analysis, cases showed improved reduction of fat tissue on the treated sides. Conclusion: This pilot study introduces a potential advance in adjuvant topical therapy aiding the outcome of non-invasive fat reduction procedures. J Drugs Dermatol. 2019;18(4):342-348.

A blinded, randomized, split-face pilot study of bruising and pain with hyaluronic acid for correction of perioral lines using no lidocaine, lidocaine alone, and lidocaine and epinephrine.

BACKGROUND: Hyaluronic acid (HA) fillers are sometimes mixed with lidocaine to mitigate pain. Whether the addition of epinephrine to lidocaine provides greater benefits in bruising and pain has not been fully reported. OBJECTIVES: The investigators explored the severity of bruising and pain in patients treated with the cohesive polydensified matrix HA (CPMHA) in 3 different preparations: CPMHA (Belotero Balance [BEL]), CPMHA with lidocaine (BEL-L), and CPMHA with lidocaine and epinephrine (BEL-LE). METHODS: In a blinded, split-face, 14-day study, 30 patients were divided into groups of 10. One group received 1.0 mL BEL in the perioral lines on 1 side and 1.0 mL of BEL-LE on the other side. A second group received 1.0 mL of BEL on 1 side and 1.0 mL of BEL-L on the other side. The third group received 1.0 mL of BEL-L on 1 side and 1.0 mL of BEL-LE on the other side. Over 3 visits, the treating investigator, the patients, and a blinded investigator rated the bruising. RESULTS: Bruising occurred in each treatment group by day 1 but resolved for half of the patients by day 7 and for all patients by day 14. Split-face comparison did not reveal a significant difference in pain and bruising scores among the 3 preparations. CONCLUSIONS: No significant difference was found in bruising or pain in patients treated with BEL, BEL-L, and BEL-LE. Studies with a considerably larger sample size are warranted to determine statistically significant and clinically meaningful differences between and among the various formulations.

A randomized double-blind trial evaluating the efficacy and tolerability of topical body treatment with TriHex Technology® combined with abdomen cryolipolysis or radiofrequency procedures.

BACKGROUND: Nonsurgical fat reduction procedures using cryolipolysis and radiofrequency are among the most popular noninvasive aesthetic procedures. In a previous study, TransFORM Body Treatment (TFB) with TriHex Technology® (ALASTIN® Skincare) improved the contour and reduced skin laxity following cryolipolysis of the arms. This product is formulated using a combination of peptides and other active ingredients designed to stimulate the autophagic breakdown of lipid droplets and expedite the apoptotic process after fat reduction procedures. AIMS: To assess the changes in abdominal volume after application of TFB for 12 weeks following cryolipolysis and radiofrequency procedures. METHODS: Following abdominal cryolipolysis or radiofrequency therapy, the subjects (N = 15) received TFB product and placebo and were randomly assigned to apply to the right or left sides of the abdomen for 12 weeks. Using 3-dimensional digital imaging analysis, subjects were evaluated at 4, 8, and 12 weeks posttreatment. RESULTS: Topical TFB resulted in increased volume loss, which was greater than that for placebo at weeks 4 (P = .0511), 8 (P = .0238), and 12 (P = .0078), respectively, and statistically significant at weeks 8 and 12. There were no reported adverse events. CONCLUSION: In this study, Topical application of TFB significantly increased adipose volume loss and improved clinical outcomes of nonsurgical fat reduction procedures.