Galderma (France)

Abstract. A series of multiple meteorological extreme events in close succession can lead to a substantial increase in total losses compared to randomly distributed events. In this study, different temporal clustering methods are applied to insurance loss data from southwestern Germany from 1986 to 2023 for the following hazards: windstorms, convective gusts, and hail, as well as pluvial, fluvial, and mixed flood events. We assess the timing and significance of seasonal clustering of single hazard types as well as their serial combination by use of both a simple counting algorithm and the clustering metric Ripley's K. Results show that clustering is significant only for certain hazard types compared to a random time series. However, clustering is robust for a combination of multiple hazard types, namely hail, mixed or pluvial floods, and storms. This particular combination of hazard types is also associated with higher losses compared to their isolated occurrence. Clusters of damaging hazards occur mainly during May–August and depend on the method of defining independent events (peaks-over-threshold method with flexible lengths vs. hours clause method with fixed lengths) and their resulting duration. This study demonstrates the relevance of considering multiple hazard types when evaluating clustering of meteorological hazards.

Acne vulgaris affects nearly 50 million people in the USA, ranking as the eighth most prevalent disease globally. This chronic inflammatory skin condition often results in sequelae, including atrophic acne scars, acne-induced macular erythema and acne-induced hyperpigmentation, impacting patients’ quality of life. This commentary article reviews the use of topical retinoids, with a particular emphasis on trifarotene cream 0.005%, for managing both acne and acne sequelae. Topical retinoids are considered central to improving treatment outcomes because of their established efficacy, safety and tolerability. Adapalene, tretinoin and tazarotene have demonstrated efficacy in reducing acne and acne sequelae in several studies. Trifarotene has been extensively studied in Phase 3 trials, demonstrating notable success in treating mild-to-moderate acne. Recently, two large-scale, randomized, blinded, Phase 4 clinical trials investigated trifarotene cream 0.005% in patients with atrophic acne scarring and acne-induced hyperpigmentation across all Fitzpatrick phototypes. The START study found that there was a greater reduction in total atrophic acne scar count in the trifarotene group compared with the vehicle group at Week 24 (55.2% vs 29.9%) with statistical significance established as early as Week 2 (P = 0.001). Based on this evidence, we recommend that topical retinoids should be introduced as first-line therapy for the treatment of acne and acne sequelae. Retinoids should be implemented into a treatment routine as early as possible, especially for patients with darker Fitzpatrick phototypes or patients at risk of atrophic acne scarring. Furthermore, retinoids should be incorporated within a comprehensive skincare regimen that includes adequate photoprotection when treating patients with darker Fitzpatrick phototypes. Finally, management of acne and acne sequelae should include maintenance therapy with topical retinoids. This article supports the American Academy of Dermatology’s call for acne sequelae treatment guidance and emphasizes the need for continued research to optimize patient care.

The current management of psoriasis does not differentiate between younger and older patients in selecting the safest and/or most effective biologic. To explore the effect of age at treatment initiation in response to biologics in patients with moderate-to-severe psoriasis in the UK and Eire. Data from patients registered in the British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR) from 2007 to 2024 on a first course of tumour necrosis factor (TNF), interleukin (IL)-12/IL-23, IL-17 and IL-23 inhibitors with at least 6 months' follow-up were included. Patients aged ≥ 16 years at registration were organized into the following cohorts: 16-24 years, 25-34 years, 35-44 years, 45-54 years, 55-64 years, 65-74 years and ≥ 75 years. The 45-54 years age group was used as the reference cohort. Biologic survival was defined as the time between treatment initiation to its discontinuation associated with ineffectiveness or the occurrence of adverse events (AEs). Adjusted hazard ratios (aHR) with 95% confidence intervals (CIs) was estimated using a flexible parametric model to compare discontinuing treatment between the age groups. Each model included exposure (biologic class), effect modifier (age groups), interaction terms, baseline demographics and clinical and disease severity covariates. In total, 14 294 patients were included and organized into the following age groups: 16-24 years, n = 847 (5.9%); 25-34 years, n = 2502 (17.5%); 35-44 years, n = 3575 (25.0%); 45-54 years, n = 3863 (27.0%); 55-64 years, n = 2338 (16.4%); 65-74 years, n = 954 (6.8%); and ≥ 75 years, n = 215 (1.5%). The interaction effects model showed that individuals aged 16-24 years were more likely to discontinue TNF inhibitors (TNFi) due to ineffectiveness than those in the reference cohort (aHR 1.30, 95% CI 1.10-1.55). For survival associated with AEs, individuals aged 55-64 years were at higher risk of discontinuing TNFi and IL-12/IL-23 inhibitors [IL-12i/IL-23i; aHR 1.33 (95% CI 1.13-1.56) and aHR 1.34 (95% CI 1.03-1.75), respectively]; those aged 65-74 years were more likely to discontinue TNFi, IL-12i/IL-23i and IL-17 inhibitors [aHR 1.89 (95% CI 1.54-2.31), aHR 2.00 (95% CI 1.47-2.73) and aHR 1.69 (95% CI 1.08-2.64), respectively], whereas individuals aged ≥ 75 years were at higher risk of discontinuing the four biologic classes. Patients aged 16-24 years with psoriasis are more likely to stop TNFi due to ineffectiveness, whereas those aged ≥ 55 years are more likely to stop biologics due to AEs. These real-world findings provide important information for clinicians treating people with moderate-to-severe psoriasis across all age groups.

Non-facial (body) rejuvenation is a treatment of increasing demand, with patients seeking to harmonize the benefits of rejuvenated facial appearance with other areas of the body. Poly-l-lactic acid (PLLA)-SCA (Sculptra®) has been approved for facial aesthetic uses since 1999 in Europe and since 2009 in the USA and more recently evaluated for the treatment of cellulite of the buttocks and thighs and other body indications. The current evidence base consists largely of prospective observational analyses and case series although systematic evaluations for a number of body areas are underway. Current data support a potential benefit for the use of PLLA-SCA for the aesthetic treatment of the neck, knees, abdomen, hands and upper arms. Improvements in aesthetic appearance (e.g. sagging, wrinkling, dimpling, cellulite) that are sustained over time with minimal side effects can be achieved. Standardization of injection protocols for different body areas is now needed along with the validation of clinical tools that can be used to agree on treatment goals and to evaluate aesthetic improvements over time. A group of international experts in the fields of facial and body aesthetics, plastic surgery and dermatology were selected based on their educational, scientific and publication merits together with clinical experience using PLLA-SCA for body rejuvenation. Here, we provide an evidence-based and expert-led consensus (14 years of off-face treatment experience) on recommendations for appropriate injection protocols for different body sites and evaluation tools when using the biostimulator PLLA-SCA for body aesthetic and rejuvenation procedures.Level of Evidence IV This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

BackgroundAesthetic improvement of the chin is increasingly requested by patients, including those of Chinese origin.MethodsA randomized, evaluator-blinded, no-treatment controlled study evaluated the effectiveness and safety of a flexible hyaluronic acid (HA) filler, Restylane® DefyneTM (HADEF), in the correction of chin retrusion in a Chinese adult population over 12 months after treatment. On Day 1, subjects were randomized 3:1 into two groups, HADEF or delayed-treatment controls, and those in the HADEF group were administered treatment. An optional touch-up treatment was administered 1 month after treatment to obtain optimal chin augmentation. The initially untreated control group was offered delayed-treatment after 6 months (including 1-month touch-up).ResultsHADEF was superior to no-treatment in improving chin retrusion according to the blinded evaluator at 6 months [Galderma Chin Retrusion Scale (GCRS) responder rate (≥ 1-point improvement from baseline) of 81% vs. 5% for untreated controls; p < 0.001, meeting the primary effectiveness objective. A majority of subjects maintained improvement at 12 months (61% in the HADEF group). All subjects reported satisfaction with results at 6 months after treatment with HADEF and aesthetic improvement rates per the global aesthetic improvement scale (GAIS) were high for 12 months following treatment, with an acceptable safety profile.ConclusionsThese results demonstrated HADEF to be effective and safe for the correction of mild-to-moderate chin retrusion in Chinese subjects, confirming findings previously observed in a western population.Level of Evidence I This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

With great interest we have read the article published by Han et al. titled ''Safety and Efficacy of Poly-L-Lactic Acid Filler (Gana V vs. Sculptra) Injection for Correction of the Nasolabial Fold: A Double-Blind, Non-Inferiority, Randomized, Split-Face Controlled Trial'' [1] . A study officially titled ''Clinical Study for the Safety and Effectiveness of Use of an Injectable Medical Device GANA VÒ for Facial Aesthetic'' (Clinicaltrials.gov ID: NCT05215054), with the described purpose to assess the effectiveness and safety of Gana V, a poly-L-lactic acid filler for the aesthetic treatment of nasolabial folds, in comparison with Sculptra (poly-L-lactic acid (PLLA), Galderma). There are several misleading incorrect statements not supported by science nor literature and shortcomings existing in the Han et al. Non-Inferiority, Randomized, Split-Face Controlled Trial that should be noted. Han et al. describe Gana poly-lactic acid (Gana V, GCS Co.) as a US FDA-approved PLLA filler which is a false statement. Of the two PLLA fillers included in the trial, only Sculptra poly-L-lactic acid (PLLA; Sculptra, Galderma) filler is US FDA approved [2]. Han et al. also state that ''Sculptra requires preparation hours before injection, ''Gana & Sabrina Fabi

BackgroundVarious botulinumtoxinA formulations are approved for glabellar lines treatment worldwide, including abobotulinumtoxinA (Dysport®).ObjectivesAssess abobotulinumtoxinA superiority versus placebo and non-inferiority versus active comparator (onabotulinumtoxinA; Botox®), for the treatment of Chinese patients with moderate/severe glabellar lines.MethodsPhase 3, randomized study (NCT02450526) comprising a double-blind (cycle 1) phase and an open-label (cycles 2−5) phase. Patients received abobotulinumtoxinA 50 units or matching placebo (5:1), active comparator (onabotulinumtoxinA 20 units) or matching placebo (5:1). In cycles 2–5, eligible patients were retreated with abobotulinumtoxinA only. Responders had glabellar lines of none/mild severity. Primary endpoint: responder rates at cycle 1, day 29 at maximum frown with abobotulinumtoxinA versus placebo (for superiority; by investigator’s live assessment [ILA] and subject’s self-assessment [SSA]), and versus active comparator (for non-inferiority; by ILA). Treatment-emergent adverse events were recorded.ResultsOverall, 520 patients were randomized. Superiority and non-inferiority, respectively, were demonstrated for abobotulinumtoxinA versus placebo (ILA, SSA; both p < 0.0001) and abobotulinumtoxinA versus active comparator. AbobotulinumtoxinA efficacy was maintained over open-label cycles; median time to onset of efficacy was 2.0 days. After 6 months, 17% of patients treated with abobotulinumtoxinA remained responders. AbobotulinumtoxinA was well-tolerated. Safety results were in line with the known profile of abobotulinumtoxinA; adverse events rate decreased with repeated treatment.ConclusionsAfter a single injection, abobotulinumtoxinA demonstrated superiority versus placebo and non-inferiority versus onabotulinumtoxinA for the treatment of moderate-to-severe glabellar lines in Chinese patients. Multiple injections of abobotulinumtoxinA demonstrated efficacy and safety in the treatment of glabellar lines in Chinese patients.Level of Evidence IThis journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.