Patient Satisfaction and Efficacy of Full-Facial Rejuvenation Using a Combination of Botulinum Toxin Type A and Hyaluronic Acid Filler.

BACKGROUND: Combination treatments using hyaluronic acid (HA) fillers and botulinum toxin Type A (BoNT-A) are common in aesthetic medicine; however, this has been evaluated in only a few clinical studies. OBJECTIVE: To evaluate subject satisfaction, efficacy, and safety of BoNT-A (Speywood Unit; s.U) and a range of HA fillers for full-facial aesthetic rejuvenation. MATERIALS AND METHODS: A 6-month, multicenter, open-label clinical study, using BoNT-A (s.U) and 5 HA fillers to treat up to 13 facial zones. Subject satisfaction questionnaires were administered 3 weeks and 6 months after the last injection. Global aesthetic improvement and improvement on each treated zone as well as safety were evaluated. RESULTS: A high level of satisfaction was achieved throughout the study, with 96.5% of subjects at least satisfied with the full-facial aesthetic outcome at 3 weeks, and 92.9% at 6 months. More than 91% considered the treatment outcome to meet or surpass their expectations, and more than 94% would recommend the treatment to others. At Week 3, subject and investigator assessment showed aesthetic improvement for all subjects. The treatment was well tolerated. CONCLUSION: The combination of BoNT-A (s.U) and HA fillers results in high patient satisfaction and in an overall improvement of aesthetic outcomes and quality of life.

Safety and effectiveness results of an innovative injectable poly-L-lactic acid-based collagen stimulator (Lanluma®)-Clinical outcomes at 9 months in a post-market study.

BACKGROUND: Injectable fillers for soft tissue augmentation stand out as one of the most favored procedures in the field of aesthetic medicine, especially in addressing the clinical signs of skin aging. Among soft tissue fillers, non-permanent fillers have been safely used in numerous medical applications for several decades. AIMS: The aim of this post-market observational, open-label, uncontrolled, multicentered, prospective study (PMS) was to evaluate the effects of an injectable poly-L-lactic acid-based collagen stimulator (Lanluma®, the study product). PARTICIPANTS/METHODS: This analysis is based on the clinical outcomes data (safety and effectiveness) collected from investigators and participants between the first injection (T0, September 2022) and 9 months thereafter (T3, June 2023) in the treatment of five body-contouring areas. RESULTS: Overall, 70 participants had 99 treatment sessions of the neck (31%), upper arm (20%), hand (17%), thigh (16%) and décolleté (15%). Lumps (neck, upper arm, hand) and nodules (neck, hand, thigh) were the most frequent adverse events (AEs) reported by investigators. All were treatment related. None were serious, severe or fatal. No AEs were reported following treatment of the décolleté. Both investigators and participants reported high levels of satisfaction during the nine-month follow-up period with the treatments in five body areas. CONCLUSIONS: These positive clinical outcomes can be attributed to a proper implementation of best practices and recommendations, and the rheological properties of the study product. This 9-month follow-up analysis should be reconsidered in light of the study's objectives for the final analysis at the 25-month follow-up.

Radiesse(®): a novel rejuvenation treatment for the upper arms.

Nonsurgical esthetic improvement of the upper arms is a desirable goal for many individuals. Radiesse(®) (calcium hydroxylapatite) is an effective dermal filler for a number of indications because of its volumizing effect and the ability to stimulate neocollagenesis. No studies have reported on its safety and effectiveness for the treatment of the upper arm. In a prospective, open-label study, 30 subjects seeking improvement in the esthetic appearance of their upper arms received injections with Radiesse(®) (1.5 mL/arm) at two separate visits, 1 month apart. Subjects returned for a follow-up visit 4 months after the second treatment. The primary endpoint was the degree of overall subject and evaluator (investigators and study nurses) satisfaction assessed using the 5-point Global Satisfaction Scale (ranging from "1" very dissatisfied to "5" very satisfied). Secondary endpoints included assessments of skin quality (flaccidity and volume distribution) using a new Visual Analog Scale for upper arms and overall assessment of treatment using the Global Aesthetic Improvement Scale. All (100%) of both subjects and evaluators were "satisfied" or "very satisfied" with treatment. The mean Global Satisfaction Score for investigators and study nurses was 4.60 and for subjects 4.53 (satisfied to very satisfied). Assessments of flaccidity and volume improved significantly compared with baseline at the post-treatment visit and also between visits. Compared with baseline, 77% of subjects were rated as considerably improved (good or great improvement) by the investigator and study nurse; 73% of subjects rated themselves as considerably improved and 43% of these rated a "great improvement." All stated they would repeat the treatment and recommend it to others. No adverse events were reported. Radiesse(®) is an effective minimally invasive treatment option for improving upper arm contours and was associated with a 100% satisfaction rate for both subjects and evaluators.