Efficacy and Safety of Tapencarium (RZL-012) in Submental Fat Reduction.

BACKGROUND: Tapencarium (RZL-012) (5-(3.6-dibromo-9H-carbazol-9-yl)-N, N, N-trimethylpentan-1-aminium chloride) is a novel injectable synthetic molecule with cytolytic properties, capable of reducing subcutaneous fat volume. OBJECTIVES: The goal of this 3-armed, randomized, double-blind, placebo-controlled phase 2b study was to determine the safety and efficacy of low- and high-dose RZL-012 vs placebo on submental fat (SMF) reduction. METHODS: Patients (n = 151, age 18-65 years) with excess SMF received a single treatment session of RZL-012 or placebo in the submental area, after which they were monitored for 84 days. SMF was assessed at baseline and after dosing with newly developed scales, namely the Clinician Chin Assessment Tool (C-CAT) and Subject Chin Assessment Tool (S-CAT). SMF was also assessed by magnetic resonance imaging (MRI) at screening and on Day 84 after treatment. RESULTS: The proportion of patients who had a 1-grade or 2-grade improvement in C-CAT and/or S-CAT on Day 84 vs baseline was significantly higher in the high-dose RZL-012 group vs the placebo group (P < .002). The relative percentage reduction in MRI-measured SMF volume (Day 84 vs screening) was significantly greater in the high-dose RZL-012 group vs the low-dose RZL-012 or the placebo group (P < .0001). Local injection site reactions were the most common adverse events (AEs). CONCLUSIONS: A single administration of RZL-012 into SMF resulted in significant improvement in submental appearance as assessed by clinicians, patients, and MRI. From a safety perspective, there were no serious AEs and no clinically significant changes in vital signs or laboratory tests over the course of the study.

Enhanced high-energy protocol using a fractional bipolar radiofrequency device combined with bipolar radiofrequency and infrared light for improving facial skin appearance and wrinkles.

BACKGROUND: Fractional bipolar radiofrequency treatment and treatment with bipolar radiofrequency combined with infrared light have been shown in previous trials to safely and effectively improve the appearance of facial wrinkles. AIMS: To evaluate a high-energy protocol with combined bipolar radiofrequency and infrared light energies for improvement in photoaged facial skin. PATIENTS/METHODS: Seventy-two patients presenting with mild to moderate facial wrinkles underwent a single full-face treatment (n=54) or two treatments (n=18) at 6-week intervals. Independent blinded assessment and investigator assessment were performed, using the Fitzpatrick Wrinkle and Elastosis Scale (0-9) and the Global Aesthetic Improvement scale. Patients also completed a self-assessment questionnaire concerning satisfaction with the treatment. RESULTS: All patients achieved some degree of improvement in their wrinkles and skin appearance, following a single treatment or two treatments with the enhanced-energy protocol. Blinded evaluation demonstrated 71% and 70% of the patients showing improvement of one unit or greater on the Fitzpatrick Scale, at the 12-week and 24-week follow-ups post-treatment, respectively. Similar results were reported by investigators. Under the Global Aesthetic Improvement Scale, investigators observed 87%, 91% and 81% of patients showing improvement at the 6-, 12-, and 24-week post-treatment end, respectively. Patients tolerated the treatments well and were satisfied with the clinical results. CONCLUSION: The enhanced-energy treatment protocol, with fractional bipolar radiofrequency treatment and treatment with bipolar radiofrequency combined with infrared light applications, yields significant improvement of skin texture, wrinkling, and overall appearance following a single treatment. The results appear gradually over time and are maintained for at least 6 months' post-treatment.

Treatment of Hyaluronic Acid Filler-Induced Impending Necrosis With Hyaluronidase: Consensus Recommendations.

Injection-induced necrosis is a rare but dreaded consequence of soft tissue augmentation with filler agents. It usually occurs as a result of injection of filler directly into an artery, but can also result from compression or injury. We provide recommendations on the use of hyaluronidase when vascular compromise is suspected. Consensus recommendations were developed by thorough discussion and debate amongst the authors at a roundtable meeting on Wednesday June 18, 2014 in Las Vegas, NV as well as significant ongoing written and verbal communications amongst the authors in the months prior to journal submission. All authors are experienced tertiary care providers. A prompt diagnosis and immediate treatment with high doses of hyaluronidase (at least 200 U) are critically important. It is not felt necessary to do a skin test in cases of impending necrosis. Some experts recommend dilution with saline to increase dispersion or lidocaine to aid vasodilation. Additional hyaluronidase should be injected if improvement is not seen within 60 minutes. A warm compress also aids vasodilation, and massage has been shown to help. Some experts advocate the use of nitroglycerin paste, although this area is controversial. Introducing an oral aspirin regimen should help prevent further clot formation due to vascular compromise. In our experience, patients who are diagnosed promptly and treated within 24 hours will usually have the best outcomes.

Combining confluent and fractionally ablative modalities of a novel 2790nm YSGG laser for facial resurfacing.

BACKGROUND: Several laser technologies exist for improving rhytides, pigmentation, and skin texture. Recent advances in technology introduced a new wavelength, 2,790 nm, erbium:yttrium-scandium-galium-garnet (Er:YSGG) for treatment of photoaging. 2,790 nm Er:YSGG has a water absorption coefficient between CO(2) laser and Er:YAG laser and has both ablative and fractional-ablative capabilities. OBJECTIVES: To evaluate the efficacy and safety of combining the ablative (confluent) and fractional-ablative modes of 2,790 nm Er:YSGG laser for treatment of photoaging. STUDY DESIGN/MATERIALS AND METHODS: In this uncontrolled, open label, prospective study, 10 subjects were enrolled and had a single treatment of combined confluent and fractional-ablative 2,790 nm lasers for photoaging. The primary clinical end point of the study was the change in Fitzpatrick wrinkle score from baseline at different time points as determined by blinded reviewer assessments. Secondary clinical end points were the improvement in fine lines, tone/texture, and pigmentation; the subjects' self assessment; the incidence of side effects; and the tolerability of treatments. RESULTS: Based on blinded photo-assessments by two independent dermatologists, subjects showed clinically and statistically significant mean improvement of 1.9 (95% CI: 1.1-2.6), 1.6 (95% CI: 0.8-2.3), and 1.2 (95% CI: 0.5-2.0) in Fitzpatrick wrinkle scores at 6 weeks, 3 and 6 months, respectively. Of the 90% of subjects who showed improvement in Fitzpatrick wrinkle scores, 78% continued to have improvement at the 6-month follow-up visit. Mild erythema observed post-treatment was resolved by the 6-week follow-up visit in all subjects. No transient or permanent post-inflammatory hyperpigmentation (PIH); or serious adverse events were reported. CONCLUSION: A combined confluent and fractional-ablative 2,790 nm Er:YSGG laser treatment improves photodamaged skin for at least 6 months. The treatment was well-tolerated and PIH was not found in our study.

Analysis of epidermal protection using cold air versus chilled sapphire window with water or gel during 810 nm diode laser application.

BACKGROUND AND OBJECTIVES: Many cutaneous laser devices incorporate a temperature-based epidermal protection system to minimize surface damage while continuing to affect targeted tissue. The use of cold air is a new technique to aid in epidermal protection during the application of cutaneous lasers. This study investigates the efficacy of cold air versus chilled sapphire in regards to epidermal preservation when used with an 810 nm diode laser. STUDY DESIGN/MATERIAL AND METHODS: White-haired pink piglets and dark-haired pigmented piglets were treated using the 810 nm diode laser in conjunction with either (1) no cryogen protection; (2) cold air alone; (3) chilled sapphire window alone; (4) cold air with water/gel; or (5) chilled sapphire window with water/gel. Laser fluence was varied by adjusting laser duration time while maintaining the intensity at 60 W. Biopsies were obtained from the sacrificed animals, stained with Masson's trichrome, and analyzed for extent of epidermal damage. RESULTS: Among white-haired pink pigs, the cold air afforded the same degree of epidermal preservation as the chilled sapphire window. Epidermal protection was further enhanced with the addition of either gel or water. Among dark-haired pigmented pigs, the chilled sapphire window alone likewise provided significant epidermal protection, although the cold air alone did not. However, with the addition of water/gel, epidermal preservation was demonstrated in both. CONCLUSIONS: Cold air is an effective means in promoting epidermal preservation, though slightly inferior to the chilled sapphire window on darkly pigmented subjects. Combining either method with water or gel further enhances surface protection, enabling safe use of higher fluences.