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.

Spot Reduction of Localized Fat Deposits on the Lateral Thighs by Simultaneous Emission of Synchronized Radiofrequency and High-Intensity Focused Electromagnetic Energy: Magnetic Resonance Multicenter Study.

BACKGROUND: Unwanted lateral fat most prominently affects the female population and may cause self-esteem issues. OBJECTIVE: To investigate the effectiveness and safety of synchronized high-intensity focused electromagnetic (HIFEM) + radiofrequency (RF) for the treatment of lateral thigh adipose tissue. MATERIALS AND METHODS: Ninety-three subjects (21-70 year old) received 4, 30-minute HIFEM + RF treatments of the lateral thighs. Magnetic resonance imaging (MRI) of the treated area was obtained at baseline, 1, 3, and 6 months post-treatment to document the changes in fat layer thickness. Furthermore, digital photographs, circumference measurements of the lateral thighs, subjects' satisfaction questionnaires, and therapy safety and comfort were documented. RESULTS: Magnetic resonance imaging revealed a significant reduction of fat tissue in the saddlebag region peaking at 3 months (-18 ± 5.5 mm; N = 51). The thigh circumference measured at 3 predefined levels decreased on average by 2.3 cm, with the greatest change at the level of 10 cm below the infragluteal fold (-3.5 cm, 3-month follow-up). Results were maintained at 6 months. No adverse events were recorded. The therapy was found comfortable with a high satisfaction rate. CONCLUSION: High-intensity focused electromagnetic + RF treatment to the lateral thigh area demonstrated effectiveness in long-term fat thickness reduction by MRI imaging. Secondary endpoint showed simultaneous effectiveness and safety.

Multicenter evaluation of a topical hyaluronic acid serum.

BACKGROUND: A new hyaluronic acid (HA) formulation was developed based on high molecular weight (MW) compounds used on the surface of the skin while using peptides to stimulate the high MW HA production by fibroblasts and keratinocytes from within the skin layers. Detailed science has been submitted to this journal in a previous publication. This multicenter study aims to validate the science by demonstrating the safety and efficacy of the product in the clinical realm. OBJECTIVES: This study evaluated the efficacy and safety of a topical HA serum in facial skin. METHODS: An open-label clinical study was undertaken over 4 months from November 2021 to March 2022. Participants applied the topical serum twice daily and were provided a gentle cleanser and an SPF 30+ to use in the morning. Follow-up visits were conducted at weeks 2, 4, and 8. At every visit, participants were measured for hydration post 15 minutes of cleansing the skin and post 15 minutes of product application for cumulative skin hydration sensor measurements. Additional procedures included participant assessments and satisfaction, investigator assessments, biopsies, and photography. RESULTS: At each follow-up visit, there was an increase in hydration measurements compared to baseline, in both immediate scores and cumulative long-term scores. At weeks 4 and 8, there was a statistically significant increase in hydration compared to baseline and the prior visit. Participants' assessments progressively increased over 2-, 4-, and 8-week intervals with significantly favorable ratings in all measured parameters. Similarly, investigator assessment grades were statistically significant (p < 0.0001) for decreased fine lines/wrinkling, crepiness, texture, erythema, and dryness, and increased (p < 0.0001) for moisture/hydration. Histology revealed increased CD44 staining in 6 of the 7 participants biopsied, denoting increased HA stimulation. In all of the participant biopsies, H&E staining demonstrated improvement in solar elastosis. Photography revealed remarkable improvement in erythema, tone, and texture. CONCLUSIONS: The study results demonstrated that the formulation produced significant improvements in immediate and long-term hydration effects on the skin as measured by the skin hydration sensor, 'wearifi' technology, comparison of before and after biopsies, and participant and investigator assessments. This high MW HA formulation produced excellent clinical improvement in skin health and hydration.

Safety, Pharmacodynamic Response, and Treatment Satisfaction With OnabotulinumtoxinA 40 U, 60 U, and 80 U in Subjects With Moderate to Severe Dynamic Glabellar Lines.

BACKGROUND: OnabotulinumtoxinA 20 U reduces glabellar line (GL) severity at maximum frown for approximately 3 to 4 months. Small studies have suggested that >20-U doses may increase the efficacy and duration of response for GLs. OBJECTIVES: The aim of this study was to evaluate safety, pharmacodynamic response, and treatment satisfaction with onabotulinumtoxinA doses ≥20 U for GLs. METHODS: This 48-week, double-blind study compared 40, 60, and 80 U onabotulinumtoxinA vs 20 U and placebo in women with moderate or severe dynamic GLs on the Allergan Facial Wrinkle Scale. The following parameters were evaluated: the percentage of subjects with investigator-assessed ≥1-grade Facial Wrinkle Scale improvement from baseline at maximum frown (responders) at Week 24; the estimated median duration of response; the proportion of mostly/very satisfied responders on the Facial Line Satisfaction Questionnaire follow-up Items 1 to 5; and treatment-emergent adverse events. RESULTS: The modified intent-to-treat population (N = 226) had a mean age of 48.0 years, with similar baseline GL severity between treatment groups. Week 24 responder rates were 0% for placebo and 16.0%, 32.0%, 30.6%, and 38.5% for onabotulinumtoxinA 20, 40, 60, and 80 U, with significant (P < 0.05) differences for 40 and 80 U vs 20 U. Median duration of response was longer with all higher doses vs 20 U (≥24.0 vs 19.7 weeks; P < 0.05 vs 20 U at Week 24). Facial Line Satisfaction Questionnaire results indicated high subject satisfaction. The incidence and severity of treatment-emergent adverse events did not exhibit a dose-response effect. CONCLUSIONS: GL treatment with onabotulinumtoxinA doses >20 U demonstrated longer duration of response and higher patient-reported satisfaction vs the on-label 20-U dose with no apparent impact on safety variables.

Efficacy, Patient-Reported Outcomes, and Safety for Millennial Subjects Treated With OnabotulinumtoxinA for Moderate to Severe Horizontal Forehead Lines.

BACKGROUND: Millennials (aged 18-34 years) represent a growing segment of the facial aesthetic market. OBJECTIVE: To evaluate investigator-assessed efficacy, patient-reported outcomes (PROs), and safety for millennials versus subjects aged at least 35 years after onabotulinumtoxinA treatment of forehead lines (FHL) across 2 phase 3 studies. METHODS: Eligible subjects with moderate to severe FHL received onabotulinumtoxinA (FHL: 20 U; glabellar lines: 20 U, with/without 24 U in crow's feet line regions) or placebo. All findings were pooled by the age group. RESULTS: Millennials composed 15% of subjects (176/1,178). Day 30 responder rates of at least 1-grade Facial Wrinkle Scale improvement in FHL severity for millennials versus subjects aged 35 years and older were 100% versus 97.8% at maximum eyebrow elevation and 78.4% versus 83.5% at rest, respectively. Responder rates were significantly greater with onabotulinumtoxinA than placebo (p ≤ .015) for both groups through Day 180. Similar trends were observed for achieving none/mild severity. Both age groups reported high satisfaction rates and improved psychological impacts with onabotulinumtoxinA treatment. No new safety signals were detected. CONCLUSION: OnabotulinumtoxinA treatment was well tolerated, and both age groups experienced significant improvements in FHL severity, high satisfaction, and improved psychological impacts after treatment. Millennials reported numerically greater improvements.

Filler frontier: what's new and heading West to the US market.

The amount of fillers approved by the United States Food and Drug Administration (FDA) for use in facial volume augmentation is diminutive in comparison to filler products employed worldwide. In the near future, several new hyaluronic acid filler products will be available to the United States market. Already approved fillers include Belotero Balance for fine lines, Juvéderm Voluma XC for midfacial volume loss replacement, and Restylane Silk for perioral lines and lip augmentation. Volbella, currently under FDA evaluation, will be used for fine-line correction and lip augmentation. The physiochemical properties, best practices, clinical uses, and side effects of these fillers are discussed. Additionally, evolving techniques such as the use of blunt-tipped microcannulas are explained.

Evaluation of the effect of fractional laser with radiofrequency and fractionated radiofrequency on the improvement of acne scars.

BACKGROUND: Options for acne scar reduction include peels, subcision, fillers, lasers, dermabrasion, and surgical excision, although not all are applicable in darker skin types. A novel device with a handpiece combining optical and radiofrequency (RF) energies along with a fractionated RF handpiece is available for nonablative resurfacing. OBJECTIVES: Our primary objective was to evaluate the improvement in acne scars and skin texture. Secondary objectives were determination of patient satisfaction and comfort and evaluation of scar pigmentation improvement. Patients received five treatments at 30-day intervals. Post-treatment follow-up visits were performed 30 and 90 days after the last treatment. RESULTS: A 72.3% decrease (p<.001) was observed on the acne scar scale from day 1 to 210. From day 30 to 210, investigator-rated changes in scarring, texture, and pigmentation improved 68.2% (p<.001), 66.7% (p<.001), and 13.3% (p=.05), respectively. Patient satisfaction scores showed no significant change over time, although patient-evaluated overall improved scores increased 60% over baseline (p=.02). CONCLUSION: This technology may be a useful, nonablative resurfacing treatment for acne scarring. Scarring, texture, and pigmentation improved significantly according to investigator-rated assessment parameters. Although patient satisfaction scores did not improve, overall improvement scores did.

Sequential treatment with triple combination cream and intense pulsed light is more efficacious than sequential treatment with an inactive (control) cream and intense pulsed light in patients with moderate to severe melasma.

BACKGROUND: Triple combination (TC) cream is a stable combination of fluocinolone acetonide 0.01%, hydroquinone 4%, and tretinoin 0.05% and is currently the only hydroquinone-containing drug approved by the Food and Drug Administration for the treatment of melasma. OBJECTIVE: To evaluate the safety and efficacy of TC cream when used sequentially with intense pulsed light (IPL) treatments in patients with moderate to severe melasma. MATERIALS & METHODS: This was a 10-week, split-face study in which 56 patients with symmetrical melasma lesions were treated with TC cream on one side of the face and an inactive control cream on the other side of the face. Patients also had two IPL treatments at weeks 2 and 6. (Topical treatment was suspended during IPL treatments ± 1 day.) RESULTS: Melasma severity was significantly less with TC cream and IPL than with inactive cream and IPL at weeks 6 (p=.007) and 10 (p=.002). Improvement in melasma was greater with TC cream and IPL than with inactive cream and IPL according to investigator and patient evaluations at weeks 6 and 10 (p<.001 for both time points). Treatment with TC cream and IPL was well tolerated. CONCLUSION: The results of this study suggest that TC cream and IPL treatment is an effective and safe treatment option for patients with melasma.

Safety and efficacy comparison of blue versus red light sources for photodynamic therapy using methyl aminolevulinate in photodamaged skin.

BACKGROUND AND OBJECTIVE: methyl aminolevulinate (MAL) is a recently FDA-approved molecule for photodynamic therapy (PDT) in the treatment of nonhyperkeratotic actinic keratoses (AK). In the U.S., aminolevulinic acid (ALA) has been used in an off-label manner with photodynamic therapy for the treatment of chronic photodamage. The published use of MAL-PDT for photorejuvenation is more limited. MAL-PDT is usually conducted with a red light source, ALA-PDT with a blue light source. The purpose of this study is to compare the use of red versus blue light sources in the treatment of photodamage using MAL-PDT, measuring safety and efficacy outcomes following treatment. STUDY DESIGN/MATERIAL AND METHODS: eighteen adult patients with moderate-to-severe photodamage of the head or upper trunk were enrolled in a prospective, single center trial of MAL-PDT for photorejuvenation. Intrapatient randomization determined split-area treatment with a blue or red light source. The majority of patients were also treated with pulsed dye laser (PDL) and/or intense pulsed light (IPL) for photoactivation. Digitial photography documented the treatment area at each visit (days 0, 2, 7 and 30). Patient and physician scoring of photodamage occurred at baseline and final visits. Side effects following MAL-PDT were evaluated. RESULTS: no statistically significant differences in signs of photodamage following MAL-PDT were observed between blue versus red light treated sides. The greatest improvement in photodamage measures following 1 MAL-PDT were pigmentation, AK and erythema. Side effects were mild in nature and did not differ between treatment sides, and all but mild erythema resolved by day 7. CONCLUSION: blue and red light have similar efficacy as the light source for MAL-PDT when combined with other light sources. Side effects following MAL-PDT with red versus blue light were similar and mild in severity. MAL-PDT is an effective treatment modality for chronic photodamage, in particular AK and pigmentation.

Foam sclerotherapy for reticular veins and nontruncal varicose veins of the legs: a retrospective review of outcomes and adverse effects.

BACKGROUND: Sclerotherapy is the criterion standard of treatment for reticular veins. Foam sclerotherapy is safe and effective, although current guidelines limit the volume of foam used per session. OBJECTIVE: To demonstrate the safety and efficacy of large-volume foam sclerotherapy for the treatment of reticular and nontruncal leg veins. METHODS & MATERIALS: A retrospective review was conducted on all patients undergoing sclerotherapy from 2003 to 2009. Contacted patients graded side effect severity and the degree of vein resolution on a 4-point scale (0-3). The occurrence of cardiovascular or pulmonary events was also recorded. Sclerosant volumes were retrieved from patient records. RESULTS: One thousand one hundred eighty-seven patients underwent sclerotherapy; 419 were successfully contacted of whom 325 had received foam sclerotherapy. The average volume of foam used per session was 16.9 mL. The average rating of adverse events was minimal to mild for all categories including hyperpigmentation (0.35), ulceration (0.06), pain (0.22), and matting or new vessel formation (0.70). The average improvement score was 1.94 (moderate improvement). No serious adverse events occurred. CONCLUSION: Large-volume foam sclerotherapy appears to be safe and effective in the treatment of intracutaneous leg varicosities. Serious adverse events are a rare occurrence, even with sclerosant treatment volumes exceeding current guidelines.

Cosmetic use of poly-l-lactic acid: a retrospective study of 130 patients.

BACKGROUND: Poly-l-lactic acid (PLLA) is an effective treatment for patients seeking to correct volume loss due to aging. Although the Food and Drug Administration has approved PLLA for use in people with the human immunodeficiency virus (HIV), it is well-suited for patients seeking cosmetic treatment. OBJECTIVE: To evaluate the efficacy and incidence of adverse events of HIV-negative patients treated with PLLA for volume restoration. MATERIALS AND METHODS: This is a retrospective, single-center study of 130 HIV-negative patients treated with PLLA from 2003 to 2008. Patient satisfaction and incidence of adverse reactions were evaluated. RESULTS: The most common reaction to PLLA treatment was the formation of nodules (8.5%). Almost all of the nodules were palpable; only one was visible. Treatment areas with the highest incidence of post-treatment nodules were the hands (12.5%) and cheeks (7.2%). Overall, patients were satisfied, with 55% having good to excellent correction; 75% of patients with five or more treatments rated their correction as good to excellent. Sixty-eight percent of all patients would repeat the procedure again. CONCLUSION: PLLA is a safe, biodegradable volumizer used to reverse the signs of aging by gradually correcting volume loss. Patients should be aware of possible adverse reactions during the course of treatment. Nodule formation is low, with most patients having good to excellent correction.

Laser lipolysis: current practices.

Laser-assisted liposuction (LAL) is a recent innovation within the field of liposculpture. In addition to body contouring, the indications of LAL are skin retraction in areas of flaccidity and fat melting for challenging surgical cases including revisions, areas of dense fibrosity, and large-volume cases. A photothermal effect explains the effects of LAL on tissue, regardless of the wavelength used. Advantages of LAL include reduced bruising, edema, pain, and recovery time. Disadvantages are most often related to thermal effects on tissue, such as skin blistering. Currently, 3 wavelengths, 980, 1064, and 1320 nm, are Food and Drug Administration-approved for LAL. Comparative studies examining the safety and efficacy of LAL have appeared in the medical literature. Technical considerations, emerging technology, and future indications are important to the success and continued development of this procedure.

New advances in liposuction technology.

Although suction-assisted liposuction under tumescent anesthesia remains the traditional method for body sculpting, newer technologies promise to increase efficiency, decrease surgeon fatigue, and minimize complication. Power-, ultrasound-, and laser-assisted devices are ideal in large volume cases and in areas of fibrous tissues as an adjunct to traditional liposuction. Although skepticism remains chemical lipolysis, more commonly termed mesotherapy or lipodissolve may be an alternative to surgical treatment of localized fat. This article reviews the recent advancements in the field of liposuction and the current literature which support their use.

Topical hemostatic agents: a review.

Topical hemostatic agents play an important role in both common and specialized dermatologic procedures. These agents can be classified based on their mechanism of action and include physical or mechanical agents, caustic agents, biologic physical agents, and physiologic agents. Some agents induce protein coagulation and precipitation resulting in occlusion of small cutaneous vessels, while others take advantage of latter stages in the coagulation cascade, activating biologic responses to bleeding. Traditional and newer topical hemostatic agents are discussed in this review, and the benefits and costs of each agent will be provided.

Update on photoprotection.

Photoprotection is an effective method for preventing damaging effects from ultraviolet radiation (UVR). Photoprotection is accomplished through the use of sunscreens, protective clothing, and safe sun practices. Sunscreens are composed of various UV filters, including inorganic/physical blockers and organic/chemical sunscreen agents. New technologies are emerging in sunscreen development and may soon be available to U.S. consumers. General guidelines for sunscreen use should be reinforced to improve patient compliance and sunscreen efficacy. Habitual use of sunscreen is recommended with UV exposure, and concerns for vitamin D deficiency with sunscreen use should not supersede proper photoprotective behavior.