Real-World Outcomes of Lip Augmentation Using a Hyaluronic Acid-Based Filler With Low 1,4-Butanediol Diglycidyl Ether Content: A Prospective, Open-Label, Multicenter, Post-marketing Study.

Background 1,4-butanediol diglycidyl ether (BDDE) is the most common cross-linker used to produce hyaluronic acid (HA)-based dermal fillers. However, BDDE may have cytotoxic and potentially mutagenic effects, raising safety concerns. Consequently, manufacturers are developing new HA filler formulations with reduced BDDE levels to mitigate potential biological risks. Here, we sought to evaluate the clinical outcomes of lip augmentation performed using an HA-based filler with a reduced BDDE content (Agex Fill Volume®; Biodue SpA, Barberino Tavarnelle, Italy) in a real-world clinical setting. Methods This was a prospective, open-label, multicenter, post-marketing study conducted over six months. Thirty adult subjects (29 women and one man) who desired a ≥1-point improvement on the validated Lip Fullness Scale 2 (LFS2) were enrolled. The primary efficacy endpoint was the post-procedural increase in the investigator-reported LFS2 compared to baseline. Other endpoints included self-perceived happiness assessed using the Happiness Measure Scale (HMS) and safety. Results Of the study participants, 73% (22/30) demonstrated an improvement of at least one point in their LFS2 scores immediately after treatment compared to baseline, thus qualifying as responders. Six months later, the responder rate, based on LFS2 scores, remained steady at 66.7% (20/30). Importantly, these aesthetic improvements were consistently associated with a positive impact on subject-reported HMS, with a significant difference (p < 0.001) between post-treatment and baseline scores. All adverse events (AEs) reported after treatment were mild. Conclusions Agex Fill Volume®, a HA filler with low BDDE content, provides a safe and effective option for enhancing lip volume in real-world aesthetic settings.

Revolutionizing Neck Rejuvenation: ABO Botulinum Toxin A Solution in Multipoint Technique and NASHA Gel Skinbooster.

BACKGROUND: Neck rejuvenation is an increasingly sought-after cosmetic procedure that offers a versatile solution to address various aging-related concerns in the neck area. Because it is non-surgical, it is an appealing choice for both patients and practitioners. This protocol introduces a highly effective approach utilizing ABO Botulinum Toxin A solution and NASHA gel 12 mg/mL for neck rejuvenation, targeting patients with muscle hypertonicity and skin degeneration.  Materials and Methods: Patient selection is based on specific criteria. ABO Botulinum Toxin A solution is administered with tailored dosages and with a multipoint technique, followed by a structured NASHA gel skinbooster regimen. Precise injection techniques address muscle hypertonicity and improve skin quality. Follow-up appointments and personalized touch-up sessions maintain results. RESULTS: This is a minimally invasive, cost-effective approach with minimal downtime. ABO Botulinum Toxin A solution's precision and composition (efficacy) make it preferred. NASHA gel 12 mg/ml consistently enhances skin quality, providing tone, elasticity, hydration, and radiance. Gradual, long-lasting improvements boost patient satisfaction and confidence. CONCLUSION: Physicians can expand their repertoire of treatment offerings with the combined use of ABO Botulinum Toxin A solution and NASHA gel 12 mg/ml for neck rejuvenation. This innovative approach aligns with ethical and environmental considerations, enhancing patient satisfaction and overall well-being. By learning and implementing this innovative protocol, aesthetic physicians can offer their patients a highly effective and sought-after (repetitioned) treatment option.  J Drugs Dermatol. 2024;23(1):1344-1348.     doi:10.36849/JDD.8095.

International Consensus Recommendations on the Aesthetic Usage of Ready-to-Use AbobotulinumtoxinA (Alluzience).

Alluzience (abobotulinumtoxinA RTU; Ipsen, Paris, France and Galderma SA, Lausanne, Switzerland) is the first ready-to-use (RTU) botulinum toxin type A liquid solution approved for the treatment of glabellar lines in Europe. In this article, the authors provide consensus recommendations on the aesthetic usage of abobotulinumtoxinA RTU. Members of the International Board on Alluzience convened to develop consensus on the treatment of glabellar lines as well as other facial wrinkles based on their own extensive experience. Consensus recommendations were developed to provide practical guidelines for injection of abobotulinumtoxinA RTU. General guidance on proper assessment, treatment planning, and patient education is provided, as well as specific injection guidelines per indication. Indications covered include glabellar lines, crow's feet, horizontal forehead lines, lateral eyebrow lift, lower eyelid wrinkles, bunny lines, drooping nasal tip, perioral wrinkles, drooping mouth corners, masseter hypertrophy, hollow cheek lines, dimpled chin, and platysmal bands. These guidelines provide a practical framework to support routine injection of facial muscles with Alluzience.

Real-World, Retrospective, Multicenter, Observational Study on the Use of the First Liquid AbobotulinumtoxinA in Italy.

INTRODUCTION: Randomized controlled trials (RCTs) suggested that liquid formulation of botulinum toxin type A (aboBoNT-A) is safe and effective, but data confirming these characteristics in a real-life heterogenous set of patients are currently lacking. This study aimed to assess the efficacy and safety of the ready-to-use aboBoNT-A solution in adults with moderate-to-severe glabellar wrinkles. METHODS: In this real-life, multicenter, retrospective, observational study, healthy adults were treated at baseline only with aboBoNT-A solution on the glabellar area and followed up for 24 weeks. Re-treatment after 20-24 weeks could also be combined with other aesthetic procedures. Family history of immune-mediated inflammatory diseases (IMIDs) was not an exclusion criterion. Patient-reported outcomes (patient's satisfaction and injection-related pain) and physician-reported outcomes (Physician Global Assessment, PGA) were collected. RESULTS: Of the 542 patients enrolled in the study, 38 had IMID family history. Injection-related pain was reported in 128 (23.62%) as mild (pain VAS = 1.34 ± 0.87) mainly by non-botulinum toxin treatment-naïve women under 50 years of age. At 48 h, physicians rated the clinical result as "improved" in 64% of patients, conversely 264 patients (48.71%) self-evaluated as "satisfied"/"very satisfied". At 4 weeks a touch-up (< 10 units) was performed in 11 (2.03%) patients and 98.2% were "highly satisfied". Re-treatment was performed in 330 (61.45%) patients, mainly botulinum-experienced, at 20 weeks and in 207 (38.55%), mainly botulinum naïve, at 24 weeks. A total of 403 (74.35%) patients were re-treated with the three-point technique and 201 (37.08%) also received hyaluronic acid filler in the lower central face and middle third. There were no cases of de novo IMIDs. CONCLUSIONS: Real-world data confirmed that aboBoNT-A is a fast, efficient, durable, reproducible, and easy-to-use drug which is also well tolerated in patients with family history of IMID.

Injectable Non-Animal Stabilized Hyaluronic Acid as a Skin Quality Booster: An Expert Panel Consensus.

Hyaluronic acid (HA) is used extensively in aesthetic medicine thanks to its documented role in skin rejuvenation. The specific applications of HA-based products are not always fully acknowledged due to a lack of consistent recommendations. In this paper, the authors have summarized available published data on the range of applications of non-animal stabilized hyaluronic acid (NASHA®) gel skin boosters (NSBs) in several anatomical areas and types of patient, as well as their own recommendations. Overall, the panel agreed that a standard initial protocol treatment of up to 3 sessions, followed by a maintenance schedule, would allow patients to improve and then preserve skin quality over time. Indeed, distinct effects are evident after the first session, but a progressive enhancement of skin texture is detectable for up to 12 months after repeat treatment at 4 to 6 month intervals. Moreover, the authors agreed that the NASHA gel, reaching the dermis, is able to reestablish a greater degree of hydration and stimulate collagen that, in turn, restores the volume and density of the skin. Thus, a strong consensus was reached that NSB procedures are minimally invasive, safe, and effective, and designed to improve skin texture and maintain skin quality.

J Drugs Dermatol. 2018;17(1):83-88.

Senile lower lid entropion successfully treated with botulinum toxin A.

BACKGROUND: Spasmodic senile entropion (SE) is characterized by the inward turning of the eyelid. SE typically occurs spontaneously, but sometimes after ocular surgery. As of today, it is still lacking a gold standard technique. AIMS: To report the results of 11 cases of involutional entropion of the lower lid successfully treated with an injection of botulinum toxin, to evaluate the clinical results, and to document the duration of relief. METHODS: Eleven patients with senile entropion were treated with abobotulinum toxin A. The orbicularis oculi muscle was injected with 35 Su units of botulinum toxin. The procedures required an average of 5 min to complete. The follow-up period was 24 months. RESULTS: The average age of the patients was 68.09 years (ranging between 62 and 75). About 7 days after the treatment, the entropion had resolved and there was only one recurrence at the 3-month visit. The recurrence rate was 27% after 6 months, and 27% after 9 months. Of note, the patients with recurrence repeated the injection and showed an increasingly long wellness period. CONCLUSIONS: Injection of botulinum toxin can treat entropion and resulted in a significantly high success rate.

Multipoint and multilevel injection technique of botulinum toxin A in facial aesthetics.

Botulinum toxin represents one of the most frequently requested cosmetic procedures. We treated 223 patients with facial wrinkles using a new technique of injection of botulinum toxin A (BTA) called multipoint and multilevel injection technique (MMIT). The aim of MMIT was to relax the muscle and not paralyze it. Patient satisfaction was evaluated by Facial Line Treatment Satisfaction Questionnaire (FTSQ). Treatment with botulinum toxin determined a good response in all patients. Facial rhytids were completely resolved in case of young skin and well reduced in case of aged skin, leaving a natural aspect both in static and dynamic wrinkles. Patient mean overall satisfaction evaluated with FTSQ was 6.4 ± 1.1. In our experience, the use of botulin toxin by MMIT consents a better calibration of action with a soft and natural result. This can be achieved by distributing the BTA dose through various injection points for each area ("multipoint injections"). Furthermore, injections can be performed at different levels ("multilevel injections"). The level of injections regulates the potency of effect on the muscle: if the level is deep (intramuscular), the effect will be strong while if it is medium or superficial (subcutaneous and intradermal), the effect will be soft. This consents a fine calibration of action on muscle activity with a personal aesthetic result.

Necrotizing vasculitis in a patient affected by autoimmune hyperthyroidism treated with propylthiouracil.

Necrotizing vasculitis is a complex phenomenon because of an inflammation of small and larger vessels with polymorph infiltration within the vessel walls and leukocytoclasis, occurring in several autoimmune diseases. Propylthiouracil (PTU) is a medication commonly used to treat hyperthyroidism, but it is associated with various rare side effects, such as antineutrophil cytoplasm antibody-positive vasculitis. In the last decades, multiple cases of PTU causing antineutrophilic cytoplasmic antibody have been reported, some of them fatal. The present authors report the case of a 34-year-old Caucasian female affected by autoimmune hyperthyroidism treated with PTU, presenting an antineutrophil cytoplasm antibody-positive necrotizing vasculitis, with high levels of anticardiolipin antibodies that involved the upper arms and buttocks. The clinical manifestations improved after discontinuing of PTU and immunosuppressant treatment.