Radiofrequency Microneedling.

Radiofrequency microneedling is a technique that allows energy to be delivered to specified target depths in the skin via needle electrodes and measures temperature and impedance within the tissue. This method of delivery and real-time feedback has increased safety and efficacy, providing clinically significant improvements in skin laxity, rhytids, and cellulite.

Novel 1726 nm laser demonstrates durable therapeutic outcomes and tolerability for moderate-to-severe acne across skin types.

BACKGROUND: Traditional acne management with topical therapy, systemic antibiotics, hormonal agents, or oral isotretinoin requires compliance and may produce significant side effects. However, alternative treatments with lasers had failed to demonstrate durable clearance. OBJECTIVE: To assess the tolerability and therapeutic outcomes of a novel 1726 nm laser treatment of moderate-to-severe acne across skin types. METHODS: A prospective, open-label, single-arm, Investigational Device Exemption-approved, institutional review board-approved study of 104 subjects with moderate-to-severe facial acne and Fitzpatrick Skin Types ranging from II-to-VI was conducted. Subjects received 3 laser treatments at 3 (-1/+2)-week intervals. RESULTS: Following final treatment, ≥50% reduction in active acne inflammatory lesions was 32.6% at 4-weeks follow-up, increasing further to 79.8% and 87.3% at 12 and 26-weeks, respectively. The percentage of subjects clear or almost clear increased from 0% at baseline to 9%, 36.0%, and 41.8% at 4-, 12-, and 26-weeks follow-up. No serious adverse events were observed related to device or protocol; treatments were well tolerated, requiring no anesthetic. Therapeutic outcomes and discomfort were similar across all skin types. LIMITATIONS: Lack of control group. CONCLUSIONS: The study findings demonstrate the novel 1726 nm laser is well tolerated with durable progressive posttreatment improvement to at least 26 weeks for moderate-to-severe acne across skin types.

Light and energy-based therapeutics for genitourinary applications: Consensus on protocols and best practices.

BACKGROUND: Lasers and energy-based technologies have been developed for genitourinary applications over the past several decades. AIMS: This consensus article aims to categorize the published articles and clinical trial data that culminated in protocol development of technology for genitourinary applications, and to develop consistent parameters in future clinical trials. MATERIALS AND METHODS: The published articles and clinical trials data on lasers and energy-based devices applied to genitourinary conditions were categorized according to device and condition and consensus developed on protocols and parameters. RESULTS: The devices in genitourinary applications were classified as fractional lasers, radiofrequency and high-intensity focused electromagnetic field therapy. The consensus of the protocols and parameters based upon the published clinical trials of their application to the vaginal and urologic conditions associated with genitourinary syndrome of menopause was developed and organized according to device and condition. DISCUSSION: The status of FDA clearances and future pathways are discussed. CONCLUSIONS: This consensus article categorizes and presents the protocols and practices for the main classes of lasers and energy-based devices for genitourinary applications in future clinical trials.

A Randomized, Multicenter, Evaluator-blind Study to Evaluate the Safety and Effectiveness of VYC-12L Treatment for Skin Quality Improvements.

BACKGROUND: Skin quality may be assessed by degrees of skin smoothness, fine lines, and hydration. VYC-12L is a recently developed hyaluronic acid filler to improve skin quality. OBJECTIVE: This was a randomized, evaluator-blind study assessing safety and effectiveness of intradermal VYC-12L treatment for improving cheek skin smoothness, fine lines, and hydration. METHODS: Participants (≥22 years) with moderate-to-severe investigator-assessed Allergan Cheek Smoothness Scale (ACSS) scores were randomized in 2:1 ratio to receive VYC-12L or control (no treatment with optional treatment). Effectiveness was assessed 1 month after last injection (initial or touch-up) by a responder rate (≥1-grade improvement from baseline on both cheeks) using investigator-rated ACSS and Allergan Fine Lines Scale (AFLS), and tissue dielectric constant probe-measured skin hydration. Safety was evaluated throughout. RESULTS: Participants (VYC-12L, n = 131; control, n = 71) were 86.1% female with a median age of 58.0 years. At month 1, ACSS and AFLS responder rates were statistically significantly higher in the VYC-12L group (57.9%, 58.3%, respectively) than in the untreated controls (4.5%, 5.4%, respectively; p < .001). VYC-12L ACSS and AFLS responder rates remained consistent throughout the 6-month follow-up. Six participants reported treatment-related adverse events; none led to study discontinuation. CONCLUSION: VYC-12L is an effective, well-tolerated treatment for lasting improvement of cheek skin smoothness, fine lines, and hydration.

Facial Aesthetic Priorities and Concerns: A Physician and Patient Perception Global Survey.

BACKGROUND: Minimally invasive and noninvasive facial aesthetic treatments are increasingly popular, and a greater understanding of patient perspectives on facial aesthetic priorities is needed. OBJECTIVES: The authors surveyed facial aesthetic concerns, desires, and treatment goals of aesthetically conscious men and women, and physicians, in 18 countries. METHODS: This was a global, internet-based survey on desired appearance and experiences with, or interest in, facial aesthetic treatments. Eligible respondents were aesthetically conscious adults (21-75 years). Eligible aesthetic physicians were required to see ≥30 patients per month for aesthetic reasons, have 2 to 30 years of experience in clinical practice, and spend ≥70% of their time in direct patient care. RESULTS: A total of 14,584 aesthetically conscious adults (mean age, 41 years; 70% women) and 1315 aesthetic physicians (mean age, 45 years; 68% men) completed the survey. Most respondents (68%) reported that aesthetic procedures should be sought in their 30s to 40s; physicians recommended patients seek treatment earlier. Respondents expressed greatest concern over crow's feet lines, forehead lines, facial skin issues, hair-related concerns, and under-eye bags or dark circles; in contrast, physicians tended to underestimate concerns about under-eye bags or dark circles, mid-face volume deficits, and skin quality. Although both physicians and respondents cited cost as a major barrier to seeking aesthetic treatments, respondents also emphasized safety, fear of injections or procedure-related pain, and concern about unnatural-looking outcomes. CONCLUSIONS: This global survey provides valuable insight into facial aesthetic concerns and perspectives that may be implemented in patient education and consultations to improve patient satisfaction following aesthetic treatments.

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.

Fractional Co2 Laser Treatment of the Vulva and Vagina and the Effect of Postmenopausal Duration on Efficacy.

BACKGROUND AND OBJECTIVES: More studies are needed to assess the long-term safety profile and clinical outcomes of lasers and energy-based devices to treat the symptoms associated with vulvovaginal atrophy. This study evaluated a series of three fractional CO2 laser treatments to the vulva and vagina with a 1-year follow-up in a postmenopausal population. STUDY DESIGN/MATERIALS AND METHODS: In this prospective, self-controlled, open-label clinical study, 18 postmenopausal females with atrophic vaginitis received 3 monthly treatments to the vulva and vagina with a fractional CO2 laser system and 1-, 3-, 6-, and 12-month follow-up. Investigators used the Vaginal Health Index (VHI) to assess changes in vaginal elasticity, fluid volume, vaginal pH, epithelial integrity, and moisture. Sexual function at each timepoint was subject-reported, using the validated Female Sexual Function Index (FSFI). RESULTS: Treatment of the vulva and vagina in postmenopausal women with fractional CO2 laser resurfacing resulted in statistically significant improvements as compared with baseline at all post-treatment and follow-up intervals to 12 months in VHI and FSFI (P ≤ 0.003 and P ≤ 0.03, respectively). Mean total VHI score increased from a baseline of 11.8-22.8 (93.2% improved) at 6-month follow-up (P = 0.0002) slightly decreasing to 21.4 (81.4% improved) at 12-month follow-up post-treatment (P = 0.0003). Mean FSFI Scores increased from a baseline of 17.9-26.3 (46.9% improvement) at 12-month follow-up post-treatment (P ≤ 0.0048). Cohort analysis revealed restoration of normal or near-normal (23-25) VHI following laser treatment in the recently menopausal (1-3 years) greatly exceeded that of the >3 years postmenopausal population and the difference was statistically significant (P ≤ 0.05). Normal/near-normal VHI at 3-, 6-, and 12-month post-treatment was 88%, 88%, and 63% in the recently postmenopausal cohort, as compared with 30%, 40%, and 10% of the >3 years postmenopausal group (P ≤ 0.05). Patient satisfaction following treatment was rated as high at 94% at 12-month follow-up. Safety findings demonstrated no-to-slight discomfort in the majority of subjects and transient erythema and edema, with no adverse events associated with treatment. CONCLUSION: Fractional CO2 laser treatment of the vulva and vagina resulted in statistically significant improvements in VHI and FSFI compared with baseline in postmenopausal population that were sustained to 12-month follow-up. Restoration of normal VHI was observed in a statistically significant greater percentage in the recently postmenopausal cohort (1-3 years) as compared with postmenopausal cohort of >3 years, suggesting that early intervention is correlated with improved outcomes. Lasers Surg. Med. © 2020 Wiley Periodicals, Inc.

At-Home Transvaginal Device Following Fractional Carbon Dioxide Laser Treatment for Genitourinary Syndrome of Menopause.

BACKGROUND: Device-based therapeutic approaches have been developed to treat women’s genitourinary post-menopausal symptoms. Fractional carbon dioxide laser resurfacing (FxCO2) has been demonstrated to be safe and effective in the treatment of GSM symptoms, however the results begin to wane by 12-months post-treatment. OBJECTIVE: This study aims at assessing the application of an at-home transvaginal red and infrared light device as a maintenance treatment commencing 12 months following FxCO2 laser treatment for genitourinary syndrome of menopause (GSM). STUDY DESIGN: Subjects completing 12-month follow-up after three fractional CO2 laser vulvovaginal treatments received an at-home device and monitored for GSM symptoms with long-term follow-up to 12 months (2 years post-laser). METHODS: 10 post-menopausal subjects completing 12-months follow-up after three FxCO2 vulvovaginal treatments for GSM were treated with an at-home red and infrared LED device. Treatment consisted of intravaginal application three times per week, and subjects were followed to 1, 3, 6, and 12 months. Subjects completed the vaginal assessment scale subject satisfaction, and QUID to assess for vulvovaginal and stress urinary incontinence (SUI) symptoms. RESULTS: Vulvovaginal symptoms measured by VAS were mean 89% improved at 12-month follow-up after FxCO2 and maintained at 73% improved over baseline (2 years post-laser) following an additional 12 months of at-home transvaginal light therapy (P<0.05). VAS symptoms gradually increased over the 12 months maintenance period by a mean of 17% (P<0.05). Mean subject satisfaction was 0 at baseline, 1.86 at 1 year following FxCO2, and 1.00 after an additional 1 year of at-home light therapy. SUI symptoms as measured by QUID were mean 81% improved at 12-month follow-up after FxCO2and maintained at 38% improved over baseline (2 years post-laser) following an additional 12-months of at-home light therapy (P<0.05). SUI symptoms gradually increased by a mean of 43% over the 12-month maintenance period (P<0.05). CONCLUSIONS: At-home transvaginal red and near infrared light therapy commencing at 12 months post-FxCO2 vulvovaginal treatment in a post-menopausal population maintained statistically significant improvements in vulvovaginal and SUI symptoms over the additional12-month period (2 years post-laser); however, a gradual return of symptoms suggests that laser re-treatment or combination withhormone therapy may be necessary to maintain optimal outcomes.J Drugs Dermatol. 2020;19(11):1076-1079. doi:10.36849/JDD.2020.1012.

Microneedle Radiofrequency.

Microneedle radiofrequency (RF) is a breakthrough in targeting skin laxity and rhytids that provides direct in situ delivery, impedance measurements, temperature measurements, energy delivery controls, and targeting of various skin depths to achieve desired clinical outcomes. Microneedle RF controls penetration depth and delivery to specified temperatures and impedance measurements, ensuring significantly improved efficacy in the treatment of mild-to-moderate rhytids and skin laxity of the face and neck, and cellulite and laxity on other body sites. Combining microneedle RF with dermal fillers and neuromodulators may be used to further improve clinical outcomes and achieve high patient satisfaction.

High Intensity Focused Electromagnetic Field (HIFEM) Devices in Dermatology"

Electromagnetic field devices, specifically high intensity focused electro-magnetic field (HIFEM), comprise the latest class of technologies being developed for dermatologic applications. The FDA clearance of these technologies includes such intended uses as "the stimulation of neuromuscular tissue for bulk muscle excitation in the legs or arms" and improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen; strengthening, toning and firming of buttocks, thighs and calves; and improve FFcment of muscle tone and firmness, for strengthening muscles in arms."1,2

Device-based treatment for vaginal wellness.

Genitourinary syndrome of menopause (GSM), encompassing the disorders of atrophic vaginitis, urinary incontinence, and pelvic prolapse, affects the majority of postmenopausal women, as well as patients who are undergoing breast cancer treatement, post-ovarectomy, post-radiation, and breast-feeding. There is a need for better treatment options for these common conditions that adversely affect physical function and quality of life and that are often underserved by existing options. Lasers have been used to treat genitourinary tissue for over 40 years, and over the past decade, several lasers and radiofrequency devices have been developed and clinically tested for the treatment of GSM, with an accumulating body of evidence demonstrating their safety and efficacy. Fractional lasers, including carbon dioxide, erbium: YAG and hybrid technologies, as well as monopolar radiofrequency devices, work by resurfacing and/or stimulating via heat the vaginal lining resulting in a re-epithelialization, neovascularization, and remodeling of the vaginal tissue from an atrophic postmenopausal state to a thickened, glycogen-rich and well-vascularized state similar to premenopausal vaginal lining. These changes are correlated clinically with improved function on a variety of validated vaginal health scales and urinary incontinence tests. Currently cleared for general application to genitourinary tissue, clinical trials are underway for FDA clearance or approval for specific GSM indications.

Prospective Multicenter Clinical Trial of a Temperature-Controlled Subcutaneous Microneedle Fractional Bipolar Radiofrequency System for the Treatment of Cellulite.

BACKGROUND: A bipolar fractional radiofrequency (RF) device was developed to generate cutaneous thermal injuries using a temperature-controlled microneedle electrode array. OBJECTIVE: Evaluate safety and efficacy of a novel subcutaneous microneedle RF for treatment of posterolateral thigh cellulite. METHODS: The study design was an institutional review board-approved multicenter clinical trial after a per-protocol analysis. Fifty subjects with Nurnberger-Muller Grade II or III cellulite were enrolled at 4 treatment centers and received 1 subcutaneous microneedle RF treatment (67°C/4-second duration). Efficacy was evaluated by blinded grading by 3 dermatologists using randomized, standardized photographs and investigator grading at baseline, 1-, 3-, and 6-month follow-up. As per the Food and Drug Administration, treatment success was defined by ≥1-point improvement on dimple number or severity of undulation irregularities scales by at least 2 of 3 blinded physicians. Study subjects' self-assessments and satisfaction questionnaires and procedural pain levels and adverse events were monitored. RESULTS: Blinded physician evaluations revealed a procedural success rate of 93% at 6-month follow-up. Procedural pain level was 3.74 ± 1.96 on a 10-point scale. There were no adverse events. Seventy-five percent of subjects were satisfied with the results at 6-month follow-up. CONCLUSION: The results indicate that subcutaneous microneedle RF treatment is safe and effective for long-term treatment of Type II and III cellulite in a single session.

Randomized, Controlled Trial of Fractional Carbon Dioxide Laser Resurfacing Followed by Ultrashort Incubation Aminolevulinic Acid Blue Light Photodynamic Therapy for Actinic Keratosis.

BACKGROUND: Aminolevulinic acid (ALA) photodynamic therapy (PDT) is an established treatment option for actinic keratosis (AK), and recently fractional carbon dioxide (CO2) laser was shown to improve outcomes; but studies of short incubation photosensitizer are lacking. OBJECTIVE: Assess the efficacy of short incubation ALA followed by blue light PDT with and without previous fractional CO2 treatment for the treatment of AK. METHODS: Randomized, paired split-design, controlled trial of fractional CO2 followed by ultrashort 15-minute versus 30-minute incubation ALA and blue light PDT for the treatment of AK on the face. RESULTS: The complete clearance rates (CRs) at 8 weeks after ALA PDT with and without FxCO2 at 30- and 15-minute ALA incubation times were 89.78% (+FxCO2) versus 71.20% CR (-FxCO2) at 30', and 86.38% (+FxCO2) versus 69.23% (-FxCO2) at 15' ALA incubation. All lesion improvements were statistically significant. CONCLUSION: This randomized, comparative paired group controlled clinical study demonstrates that ultrashort 15- and 30-minute incubation ALA PDTs are of limited efficacy for the treatment of AK. Pretreatment with fractional ablative resurfacing yields statistically significant greater AK clearance with ALA-PDT at ultrashort ALA incubations followed by blue light.

Laser and light-based treatments of acne and acne scarring.

The treatment of acne and acne scarring with lasers and light-based and energy-based technologies has become an integral component of our therapeutic arsenal. Lasers including infrared wavelengths and pulsed dye lasers; light devices including blue light, red light, and broadband light; and photodynamic therapy with aminolevulinic acid and methylaminolevulinic acid have been shown to be effective in the treatment of acne vulgaris. The optimal outcomes are achieved with photodynamic therapy combined with medical therapy. Acne scarring has been best treated with lasers, including nonablative infrared lasers, fractional nonablative and ablative laser resurfacing, and most recently needle-based radiofrequency devices.

Light and energy based therapeutics for genitourinary syndrome of menopause: Consensus and controversies.

Gynecologist and plastic surgeons pioneered the application of lasers in medicine and surgery almost 5 decades ago, initially used to treat cervical and vaginal pathologies. Ever since, energy-based devices have been deployed to treat pelvic pathologies and improve fertility. Recent technological developments triggered an unprecedented wave of publications, assessing the efficacy of fractional laser, and radiofrequency on the vaginal wall in reversing natural aging processes. Studies have shown that a certain degree of thermal energy deposited on the vaginal wall stimulates proliferation of the glycogen-enriched epithelium, neovascularization, and collagen formation in the lamina propria, and improves natural lubrication and control of urination. This review aimed to review such data and to guide future research. A unique assembly of experts from around the globe, compiled and edited this manuscript based on a thorough literature review and personal experience. Lasers Surg. Med. 49:137-159, 2017. © 2017 Wiley Periodicals, Inc.

Jasmonates and Tetrahydrojasmonic Acid: A Novel Class of Anti-Aging Molecules.

Jasmonates are plant-derived hormones from linoleic acid that were originally isolated from jasmine, and which are involved in plant stress regulation, wound repair and defense. They have been demonstrated through in vitro and in vivo studies to possess anti-neoplastic properties. Most recently, a novel jasmonate analog was developed, tetrahydrojasmonic acid (LR2412), which possesses favorable characteristics for cutaneous application and which induces improvements in epidermal hyaluronic acid and thickness. Clinical application of LR2412 to facial skin has been demonstrated to reduce the appearance of wrinkles and photoaging. In this issue, a clinical trial is published demonstrating the results of topical application of this agent for th cosmetic treatment of wrinkle appearance, poor texture and large pores.

Clinical Assessment of a Novel Jasmonate Cosmeceutical, LR2412-Cx, for the Treatment of Skin Aging.

BACKGROUND: The jasmonates are a novel class of plant-derived anti-aging compounds. Among these, LR2412-Cx (tetrahydrojasmonic acid, Visionnaire) has been demonstrated to reduce photoaging and the appearance of wrinkles, as well as to upregulate collagens, hyaluronic acid and fibrillin. OBJECTIVE: To clinically study the cosmetic effects of a novel jasmonate complex LR2412-Cx in the treatment of visible skin aging. METHODS: LR2412-Cx was evaluated in a 15-subject open-label prospective clinical trial for the treatment of fine wrinkle appearance, texture, and pores. Subjects were evaluated by an investigator at baseline, day 1, day 3, and week 6 with the Alexiades comprehensive grading scale of skin aging, and introducing a novel pore-grading scale and subject quality of life assessments. RESULTS: The mean (SEM) at baseline and at week 6 following twice-daily application were: for the appearance of wrinkles 2.91 (0.12) and 2.70 (0.10); for texture 2.91 (0.10) and 2.55 (0.10); and for pores 3.29 (0.08) and 2.46 (0.09), respectively. The differences in all 3 categories at all follow-up intervals were statistically significant (P<.005). The percentage improvement in investigator-assessed grades relative to baseline at day 1, day 3, and week 6 were: 2.3%, 4.9%, and 7.4% for the appearance of wrinkles, 5.7%, 9.4%, and 12.4% for texture, and 14.2%, 21.6% and 25.2% for pores, respectively. No significant untoward effects were reported. CONCLUSION: Visionnaire LR2412-Cx is a novel jasmonate-containing compound that is safe and effective for the cosmetic treatment of fine wrinkle appearance, texture, and pores of the facial skin.