Efficacy and Safety of RelabotulinumtoxinA, a New Ready-to-Use Liquid Formulation Botulinum Toxin: Results From the READY-1 Double-Blind, Randomized, Placebo-Controlled Phase 3 Trial in Glabellar Lines.

BACKGROUND: RelabotulinumtoxinA (RelaBoNT-A, Galderma, Uppsala, Sweden) is an innovative, ready-to-use liquid botulinum toxin A, produced using PEARLTM manufacturing technology that yields a potent, complex-free formulation. OBJECTIVES: The READY-1 study examined efficacy and safety outcomes following a single RelaBoNT-A treatment for glabellar line correction. METHODS: Adults with moderate-to-severe glabellar lines received RelaBoNT-A (50 U) or placebo in a 3:1 randomized, 6-month, Phase 3, multicenter, double-blind study. Primary endpoints (examined at Month 1, maximum frown) comprised the composite ≥2-grade response, defined as ≥2-grades' improvement from baseline on concurrent investigator (GL-ILA) and subject (GL-SLA) severity scales (US endpoint), and the investigator-reported responder rate for subjects scored as 0 (none) or 1 (mild) (GL-ILA scale only; EU endpoint). Subject satisfaction and treatment-emergent adverse events (TEAEs) were reported. RESULTS: Overall, 297 adults were randomized and treated. Month 1 composite ≥2-grade responder rate was 82.9% (RelaBoNT-A, N=199) versus 0% (placebo, N=67; p<0.001). Month 1 investigator-reported none-or-mild responder rate was 96.3% (RelaBoNT-A) versus 4.5% (placebo; p<0.001). GL-ILA scores (none-or-mild; ≥1-grade improvement) remained higher with RelaBoNT-A (23.6%; 58.1%) versus placebo (1.5%; 10.4%) through Month 6 (p<0.001). In the Kaplan-Meier analysis, 75% still showed GL-ILA and GL-SLA improvements from baseline at 169 days (end-of-study). Subjects reported onset of effect from Day 1 (39%) and satisfaction with natural-looking results (96.8%; Month 1). RelaBoNT-A-related TEAEs were low (3.6%) and typically mild. CONCLUSIONS: A single RelaBoNT-A treatment was effective and demonstrated a favorable safety profile. RelaBoNT-A provided significant improvements in glabellar line severity, high satisfaction, rapid onset, and enduring effectiveness throughout the 6-month study period.

Snail extract for skin: A review of uses, projections, and limitations.

BACKGROUND: Snail mucin is becoming increasingly popular for its wide range of ingredients and potential benefits. Snail extract's widespread appearance in cosmetic formulations encourages an investigation into the medical and cosmetic benefits. AIMS: This study aims to explore current literature on the variety of snail mucin applications. Specifically, we present a review of the uses, global market estimates and projects, and limitations to snail mucin. METHODS: A literature search was conducted on PubMed reviewing snail mucin and their application in medical and dermatologic fields examining their uses. Economic reports were also investigated for Global Market estimates. RESULTS: The therapeutic use of snail mucin in medical fields has been studied as antimicrobial agents, drug delivery vehicles, antitumor agents, wound healing agents, and biomaterial coatings among others. Additionally, the use in cosmetic fields includes antiaging, hydrating, anti-acne, scarring, and hyperpigmentation treatments. It is important to highlight that most studies conducted were preclinical or small clinical studies, stressing the need for additional large-scale clinical trials to support these claims. Investigations into the global market found estimates ranging from $457 million to $1.2 billion with upward projections in the upcoming decade. Limitations include ethical habitats for collection, allergy investigation, and missing clinical studies. CONCLUSIONS: The findings presented here emphasize the expanding uses of snail mucin and its ingredients alongside a growing market cosmetic industry should consider. We also emphasize the need for appropriate clinical trials into the stated benefits of snail mucin to ensure consumer safety and ethical extraction of mucin.

The role of the beautician in reducing striae.

INTRODUCTION: Striae distensae are a permanent skin defect that can affect 50%-90% of the population. The appearance of the changes resembles spindle-shaped skin bands. The skin in this area is wrinkled, thin and looks like a scar. Most often, the changes are found on the skin of the abdomen, buttocks, breasts, thighs, and back. The appearance of striae means that the skin in this area has no hair follicles, sebaceous, and sweat glands. This skin is flabby, not very elastic and, what is very characteristic, the pigmentation of the skin affected by striae is much lower than in healthy skin. Cosmetology in the 21st century is developing very dynamically, new technologies are being developed, new cosmetological devices are being created and combined with treatments that have been known for a long time. Today's science offers hope for people who have struggled with reducing striae for many years and nowadays, nothing is impossible. AIMS: The objective of this article is to provide information about cosmetological treatment used to reduce striae. METHODS: In this article, we reviewed the published literature, article published in peer-reviewed journals. RESULTS: Today's cosmetology offers a wide range of numerous treatments, but the best results are achieved through a synergy of two or more treatments. But we should not forget that we should respond to each customer individually. CONCLUSION: The striae are not a problem that should be ignored. The beauty therapist is able to reduce them and help the client to improve the appearance of their skin.

A Multicenter Pilot Study of a Novel Allograft Adipose Matrix in Malar and Prejowl Volume Restoration.

Background: Allograft adipose matrix (AAM) offers a novel, off-the-shelf, and readily available natural option in the treatment of facial soft tissue volume and reconstructive deficits. AAM is a natural soft tissue supplement or replacement that can support cushioning and volume correction. A prospective multicenter pilot study evaluated AAM in facial volume restoration. Methods: Eleven women (mean age of 55.8 ±â€…10.9 y) with midface volume deficit were followed up for 24 weeks after AAM treatment in this institutional review board-approved multicenter pilot study. The clinical safety and efficacy of the AAM treatment were evaluated using clinical scales and three-dimensional quantitative facial photography. Results: AAM was safe to address facial volume deficits, with minor site-related adverse events and discomfort that resolved within 2-4 weeks. Observations also revealed facial volume improvements throughout the study with 91% positive responders. At week 24, the subject facial satisfaction scores revealed an 86% increase compared to baseline, along with a statistically significantly improved midface fullness compared to baseline. Conclusion: AAM offers a natural and safe option for midface volume restoration and supports overall satisfaction and volume improvements.

A simple drug-delivery microneedling technique modality successfully improves linear atrophic scars.

BACKGROUND: Atrophic scars are white, dermal depressions, caused by the destruction of collagen fibers and decrease in epidermal cells, following inflammation after different types of trauma. They lead to significant physical, aesthetic and psychological barriers and their treatment remain a therapeutic challenge for dermatologists. Microneedling has been shown to improve scars by stimulating angiogenesis and neocolagenesis and the combination of anti-fibrotic drugs could potentialize the results. METHODS: We present 8 cases of patients with linear scars, successfully treated with two sessions of a new Microneedling technique, using a tattoo machine, associated with drug delivery of 5-FU. RESULTS: A marked improvement in scar pigmentation and texture were noted by patients and doctors, 6 months following the sessions of MMP and drug delivery with 5-FU, in different body sites. We also showed that the assessment scores of at least one of the professionals with those of the patient had significant correlations with each other, which shows consistency between the qualitative assessment instruments. We also showed that the cause of the injury can influence joint assessment scores (physicians plus patient) or those exclusive to professionals trained for the assessments, generating evidence that the cause of the injury can influence the treatment outcome itself. CONCLUSIONS: We present an inexpensive and promising approach that can be easily done as an in-office procedure. Larger, multicenter studies are needed to validate this technique among the first line therapies for acne scar treatment.

Efficacy and safety of high-intensity, high-frequency, non-focused ultrasound parallel beams for facial skin laxity.

BACKGROUND: Ultrasound energy has been used for dermal rejuvenation to treat fine lines, wrinkles and to lift lax skin. High intensity ultrasound waves induce thermal injury in the dermis, stimulating neocollagenesis and neoelastinogenesis. OBJECTIVE: To assess the efficacy, utility, and safety of a novel ultrasound device that uses high-intensity, high-frequency, non-focused ultrasound parallel beams to lift lax facial skin in the eyebrow, submental, and neck areas. MATERIALS AND METHODS: Fifteen subjects aged 40-69 years were enrolled in a prospective clinical trial. Two treatment sessions were performed with the high-intensity non-focused ultrasound parallel beam device followed by 3- and 6-month follow-up visits. Treatment results were assessed by study investigators, evaluating baseline and posttreatment photographs by applying physician global aesthetic improvement scale. Pain was evaluated immediately after each treatment using 0-10 visual analog scale. Any adverse event that occurred during the study period was documented and examined. RESULTS: Fifteen subjects with a mean age of 55 ± 2 years completed the study. Photographs that were taken at baseline and follow-up visits were compared and examined. An improvement pattern was detected in all treated areas in both follow-up visits and persisted stably throughout the study. The mean pain score was 5.6 according to the visual analog scale. CONCLUSION: The novel ultrasound device that uses high-intensity, high-frequency, non-focused ultrasound parallel beam was shown to improve safely and efficiently facial lax skin resulting in eyebrow, submental, and neck skin lift while experiencing tolerable pain.

Literature review of adverse events associated with cryolipolysis.

BACKGROUND: Cryolipolysis is a noninvasive procedure for localized fat reduction and body contouring. This technique utilizes controlled cooling to induce adipocyte apoptosis without damage to overlying skin and other tissue. Although the procedure was once thought to be relatively harmless, recent studies have shed light on the risks of adverse effects (AEs). AIMS: The aim of this article was to review AEs in cryolipolysis as published in clinical data. METHODS: A comprehensive search was performed in PubMed, using relevant keywords such as "cryolipolysis," "CoolSculpting," "adverse effects," "complications," and "side effects" with no set data range. The search was limited to studies published in English. The selected studies encompassed a variety of study designs, including randomized controlled trials, prospective cohort studies, case series, case reports, and reviews. CONCLUSIONS: Since its FDA approval in 2010, our understanding of the potential risks and complications associated with cryolipolysis has grown significantly, and shown that the procedure may not be as harmless as once thought. Continued post-market surveillance of cryolipolysis devices combined with documenting of AE cases help providers better understand the true risks associated with this procedure. As "cryolipolysis" and "CoolSculpting" are often used interchangeably, further research is needed to understand if AEs such as paradoxical adipose hyperplasia (PAH) that occur both inside and outside the United States are CoolSculpting cases or linked to other devices. Additionally, further studies are needed to understand the pathophysiology of such sequelae as PAH, and to better recognize the risks and potential complications associated with cryolipolysis so that we can more accurately inform patients.

A review of research for a cryolipolysis technology.

BACKGROUND: Obesity and excess body fat are known health issues and a major aesthetic concern. Numerous modalities have been developed to address unwanted deposits of adiposity, including the development of various noninvasive methods overcoming the limitations and risks of invasive alternatives. Cryoadipolysis, also known commonly as cryolipolysis, involves the harnessing of selective cryolysis, the selective cold-based damaging of subcutaneous fat cells which die via apoptosis, and are removed naturally by the body over time. AIMS: To provide a brief but comprehensive summary of the literature supporting two related cryoadipolysis devices that are only available outside of North America, Cooltech and Cooltech Define (Sinclair). RESULTS/DISCUSSION: Review of 10 available clinical studies evaluating the two devices, specifically, showed both devices to be safe, with side effects profiles comparable to those of similar platforms in the armamentarium. Both operate by non-invasively lowering the temperature of localized subcutaneous fat and maintaining it at or below a threshold that causes disruption of adipocytes via crystallization, inducing apoptosis (programmed cell death). Over time, clinically significant reductions in fat thickness and circumference of the treated area were noted. Patient satisfaction is high. The literature also highlights the necessity of adherence to patient selection and device use guidelines to minimize potential for rare paradoxical adipose hyperplasia and maximize patient satisfaction.

Treatment of mild to severe acne with 1726 nm laser: A safe alternative to traditional acne therapies.

INTRODUCTION: Acne is the most common reason for dermatology consultation in adolescents and young adults. Consultation is often delayed despite unsuccessful self-treatment. Postponing effective treatment places acne sufferers at higher risk for permanent acne scars and post-inflammatory pigment changes. AIM: This review discusses clinical challenges with present therapeutic options for acne treatment and the role of a 1726 nm laser for acne. METHODS: Current acne treatment guidelines were reviewed. A literature review was conducted for trials of light-based acne therapy. The selectivity of previous light-based therapies was reviewed. RESULTS: Available acne therapy is effective, but treatment-related side effects are common. Acne treatment guidelines do not include recommendations for light-based treatments. Different types of light-based treatments have been tried but until now no wavelength specifically targeted sebaceous glands. CONCLUSION: The 1726 nm laser is safe and effective for treating mild to severe acne in all Fitzpatrick skin types. Acne resolution is apparent within the first month and improves for up to 2 years beyond treatment.

Neurogenic Rosacea Treatment: A Literature Review.

Rosacea is a chronic skin disorder involving central facial erythema secondary to vascular instability and cutaneous inflammation. Rosacea is divided into different subtypes based on the morphology of the rash — erythematotelangiectatic, papulopustular, phymatous, and ocular rosacea. A less-known subtype called neurogenic rosacea has been proposed to categorize patients suffering from rosacea with erythematous flushing and burning sensation that is refractory to traditional treatment. There is minimal data on this subgroup of rosacea patients and its potential treatment options. This review aims to explore current medical literature to define characteristics of neurogenic rosacea and its management. We performed a systematic search of PubMed database and identified 6 articles meeting inclusion criteria with a total of 37 patients with suspected neurogenic rosacea. Combination treatments with topicals (eg, metronidazole, brimonidine), as well as oral medications including vascular (eg, beta blockers), psychiatric (eg, diazepam, duloxetine), neurologic (eg, pregabalin, sumatriptan), and antibiotic agents (eg, rifaximin), were often cited to have better outcomes, but this finding was highly variable between patients. There were isolated reports of effective management with onabotulinumtoxinA intradermal injections and endoscopic thoracic sympathectomy treatment. Current literature supports selecting agents aimed at treating the major symptom pattern (eg, erythema, telangiectasias, burning sensation). Neurogenic rosacea treatment: a literature review. Ivanic MG, Oulee A, Norden A, et al. J Drugs Dermatol. 2023;22(6):566-571. doi:10.36849/JDD.7181  .

DMT310, a novel once-weekly topical treatment for patients with moderate-to-severe acne vulgaris: Results of a phase 2b randomized, double-blind, placebo-controlled trial.

BACKGROUND: Poor patient adherence with antiacne medications is a common clinical challenge. DMT310, a natural, topical product with a once-weekly application schedule, may alleviate this obstacle. OBJECTIVE: Evaluate the safety, tolerability, and efficacy of DMT310 in treating moderate-to-severe acne. METHODS: This 12-week, randomized, double-blind, placebo-controlled, multicenter clinical trial enrolled participants 12 years and older with moderate-to-severe acne. RESULTS: The intent-to-treat population included a total of 181 participants (DMT310, N = 91; placebo, N = 90). Participants who received DMT310 vs participants treated with placebo demonstrated a statistically significant greater reduction in the number of inflammatory and noninflammatory lesions at all time points: inflammatory lesion counts at week 12 (-15.64 vs -10.84, P < .001); noninflammatory lesion counts at week 12 (-18.26 vs -12.41, P < .001). DMT310-treated participants also had higher rates of Investigator's Global Assessment treatment success than participants in the placebo group at all time points: Investigator's Global Assessment at week 12 (44.40% vs 17.78%; P < .001). No serious treatment related adverse events occurred. CONCLUSIONS: DMT310 once-weekly topical treatment significantly reduced both inflammatory and noninflammatory lesions and yielded a greater proportion of Investigator's Global Assessment treatment success at all time points in participants with moderate-to-severe acne.