Single Treatment Protocol With Microneedle Fractional Radiofrequency for Treatment of Body Skin Laxity and Fat Deposits.

BACKGROUND AND OBJECTIVES: Treatment modalities have been developed to address patient concerns with skin laxity and focal adipose excess. A previously published multicenter clinical trial reported improvement in cellulite severity after a single dermal and subcutaneous treatment on the upper thigh with a microneedle radiofrequency device. In the current study, this device was used to improve the esthetic appearance of body skin laxity and localized fat deposits above the knee, upper arms, and upper-mid back/axillary region ("bra-line"). STUDY DESIGN/MATERIALS AND METHODS: Subjects with cellulite, skin laxity, and/or subcutaneous adipose excess in the suprapatellar region of the anterior thigh, upper arms, and bra-line underwent a single dermal and/or subcutaneous treatment. Investigators and subjects assessed outcome at 1-, 3-, and 6-month follow-up, using 5-point Likert scales for global esthetic improvement, skin laxity improvement, and satisfaction. RESULTS: In total, 31 females (mean age 51 ± 9 years) with Fitzpatrick skin types I-IV received a single treatment on 62 treatment areas: 22 upper arms, 34 suprapatellar, and 6 bra-lines. Investigator assessments at 1, 3, and 6 months for global esthetic improvement and skin laxity for the upper arms and bra-line demonstrated improvements in 100% of subjects at all timepoints; for the suprapatellar region, these values were 69%, 92%, 65%, and 85%, 92%, 65%, respectively. Investigator satisfaction at each timepoint was satisfied or very satisfied in 80%, 100%, 90% for upper arms; 80%, 80%, 80% for bra-line; and 50%, 81%, 65% for suprapatellar region. Subject self-assessments at 1, 3, and 6 months for global esthetic improvement and skin laxity for the upper arms demonstrated improvements in 100% of subjects at all timepoints; for the bra-line, these values were 40%, 60%, 80%, and 60%, 60%, 80%, respectively; for the suprapatellar region, these values were 81%, 92%, 88%, and 69%, 85%, 88%, respectively. Subject satisfaction at each timepoint was satisfied or very satisfied in 80%, 100%, 100% for upper arms; 40%, 40%, 80% for bra-line; and 50%, 77%, 65% for suprapatellar. Treatments were well tolerated with subjects reporting transient erythema and edema associated with 69% and 46% of treatments, respectively. Mild bruising, resolving within 5 days, was reported after 32% of the treatments. CONCLUSION: Microneedle fractional radiofrequency provides a single treatment protocol to improve the esthetic appearance of body skin laxity and localized adipose excess to the upper arms, bra-line, and suprapatellar regions. Further study is warranted to evaluate the degree of improvement and long-term effect beyond 6 months post-treatment. Lasers Surg. Med. © 2021 The Authors. Lasers in Surgery and Medicine published by Wiley Periodicals LLC.

Improper Potency and Impurities in Compounded Polidocanol

Polidocanol is an FDA-approved sclerosant indicated for treating uncomplicated spider veins and reticular veins in the lower extremities. Despite restrictions against compounding drugs that are essentially copies of FDA-approved or commercially available products, polidocanol is also available from compounding pharmacies and outsourcing facilites. Compounded drug products are not FDA-approved and have not undergone premarket FDA review for safety, effectiveness, and quality. Seven samples of polidocanol were obtained from three compounding pharmacies and analyzed using high pressure liquid chromatography. None of the samples contained the labeled concentration of polidocanol and five contained excessive levels of impurities. Since the potency and purity of compounded polidocanol injection cannot be assured, physicians who use these products should consider FDA-approved products to ensure optimal safety and efficacy. J Drugs Dermatol. 2019;18(11):1124-1127.