Berthold Rzany

IncobotulinumtoxinA has been approved for treatment of glabellar frown lines (GFL) in the United States, all major European markets, South Korea, and Argentina and in Russia and Mexico for the treatment of mimic wrinkles and hyperkinetic facial lines, respectively. Prospective, 2-year, open-label, multicenter, repeat-dose, Phase III trial investigating the safety and efficacy of incobotulinumtoxinA for the treatment of GFL. Subjects with moderate or severe GFL on the Facial Wrinkle Scale (FWS), enrolled from previous trials, were treated with 20 U of incobotulinumtoxinA per cycle (up to eight treatment cycles, treatment interval at least 85 days). Efficacy was measured according to the investigator-assessed percentage of responders on the FWS (subjects with a score of 0 or 1) at rest and maximum frown on Day 30 of each cycle, subject assessments, and onset and duration of treatment effect. In 796 subjects, 77% to 88% were responders at rest, and 79% to 90% were responders at maximum frown. Onset was rapid; subjects reported effects in the first few days after treatment. No new tolerability or safety concerns were reported. IncobotulinumtoxinA injections were well tolerated and resulted in efficacy in the treatment of GFL for up to 2 years.

Full-face rejuvenation with dermal fillers in patients with multiple aesthetic indications is rarely studied. To assess whether a new range of hyaluronic acid filler is suitable for full-face rejuvenation and to evaluate efficacy, safety, and patient satisfaction. In this 6-month study, participants could receive five different fillers from the same range (HA(E) )for up to eight indications (periorbital lines, tear troughs, cheeks, cheek folds, nasolabial folds, upper lip lines, lips, and marionette lines). Outcomes included global aesthetic improvement, improvement in each indication, adverse events, local tolerability, and satisfaction. Seventy-seven participants with a mean age of 54.5 were enrolled; 48.1% had five or more indications treated. Mean total injection volume (baseline and touch-up) per participant was 6.7 mL. At month 6, 92.1% of participants remained at least improved over baseline, 79.7% of participants were satisfied or very satisfied with the durability of the results, and 63.0% of participants felt a lot or much better than before injection. No specific safety concerns were reported except expected injection site reactions. In participants with multiple indications, full-face rejuvenation using HA(E) provided effective, safe, satisfactory results.

Increasing volume is an important part of facial rejuvenation since volume loss is common and typically age-related. HA E Volume is a moderately firm gel designed to be injected into the subcutaneous tissue for volume enhancement. To assess the efficacy, patient satisfaction, and safety fo HA E Volume in patients with bilateral volume loss of the cheeks. This was a multi-center, six-month, open-label study. Subjects received HA E in the cheeks at baseline, and a touch-up injection was optional three weeks later. Global aesthetic improvement, cheek thickness (caliper measurements),changes in volume using three-dimensional (3-D) photo analysis, adverse events and injection site reactions were evaluated at each visit. Optimal correction was defined as results obtained three weeks after last injection. A subject satisfaction questionnaire was performed three weeks after the last injection. Investigators evaluated the great majority of subjects as much or very much improved in terms of aesthetic improvement of their cheeks at week 3 and at mounts 3 and 6 (89.3%, 90.9%, and 76.4%, respectively). After six months, 65.8 percent of the correction achieved at week 3 (optimal correction) was maintained in terms of cheek thickness (caliper assessments), confirmed by 67.7 percent of the volume maintained based on 3-D volume analyses. The majority of subjects (92.1%) were satisfied or very satisfied with their aesthetic outcome. A good tolerability profile was observed. Treatment with HA E Volume in cheeks led to good aesthetic improvement, sustained results confirmed by caliper and 3-D volume assessments, and high subject satisfaction.

Injectable fillers are frequently used to restore volume and correct wrinkles in perioral region. However, evidence for perioral indications is scarce. Assess the efficacy, patient satisfaction, and safety of new range of hyaluronic acid fillers (HA E) in perioral enhancement. This was a multi-center, six-month, open-label study. At baseline, subjects could receive HA E Touch, HA E Classic, HA E Lips and HA E Deep for the treatments of lips, upper lip lines, nasolabial folds and marionette lines, and a touch-up infection was optional three weeks later. Lip Fullness Grading scale (for lips), wrinkle assessments (Lemperle Rating Scales for the remaining indications), adverse events, and local tolerance were evaluated at each visit, and 3-D volume analyses (for nasolabial folds and lips only) at each post-baseline visit. Optimal correction was defined as results obtained three weeks after last injection. A subject satisfaction questionnaire was performed three weeks after last infection. Overall, HA E Lips was infected for lip enhancement, HA E Thouch and HA E Classic for upper lip lines, and HA E Classic and HA E Deep for both nasolabial folds and marionette lines. After six month, around a 1-grade improvement persisted according to the lip fullness and wrinkle assessment scales. The long duration of effect was confirmed by 3-D analyses, with 62.7-71.4 percent of volumes obtained at week 3 (optimal correction) maintained after six months. The majority of subjects (from 80% for upper lip lines with HA E Classic to 94.8% for nasolabial folds with HA E Deep) were satisfied or very satisfied with their aesthetic outcome. All products were safe and well-tolerated. Perioral enhancement with HA E fillers led to sustained effect in terms of lip fullness, wrinkle and 3-D volume assessments, and high subject satisfaction.

The periorbital region is a challenging area for injectable filler. Overcorrection and/or the use of unsuitable fillers may lead to unwanted results. As evidence for this region is limited, most physicians follow a trial and error approach. Assess the efficacy, patient satisfaction, and safety of the HA E filler range in periorbital rejuvenation. This was a multi-center, six-month, open-label study. Subjects could receive HA E Touch, HA E Classic, and HA E Deep for the treatment of tear troughs and periorbital lines at baseline, and an optional touch-up three weeks later. Global aesthetic improvement for both indications, periorbital wrinkle assessments (Lemperle Rating Scale), 3-D volume analysis (for tear troughs only), adverse events and injection site reactions were evaluated at each visit. A subject satisfaction questionnaire was performed three weeks after last injection. Overall, HA E Classic and Deep were infected for tear troughs, and HA E Touch for periorbital lines. Mean aesthetic improvement in tear troughs was 1.5-2 grades for both products at each post-baseline visit, and results of the clinical evaluation were confirmed by results of 3-D volume analysis. Improvements of periorbital lines in both aesthetic outcomes and wrinkle severity were around 1.5 grades at week 3, and close to 1 grade at month 6. The majority of subjects were satisfied or very satisfied with their aesthetic outcome. Treatments of both indications were safe and well-tolerated, with only mild and transient injection site reactions reported. This HA E filler range is suitable for rejuvenation of the periorbital region, which leads to safe results, long-lasting efficacy and high levels of patient satisfaction.

Background: Hyaluronic acid (HA) fillers such as Restylane^® are frequently used for the correction of facial soft tissue defects. Objective: To compare the efficacy and safety of a novel HA filler, Emervel^® Classic, with those of Restylane in the treatment of moderate nasolabial folds. Methods: This was a split-face, randomized and evaluator-blinded comparison study. Subjects were randomized to receive an injection of Emervel Classic or Restylane on their left or right side. Efficacy was evaluated based on the change in Wrinkle Severity Rating Score (WSRS) from baseline. Local tolerability was assessed based on subject diary, which recorded the severity of erythema, oedema/swelling, bruising, pain/tenderness and pruritus during the first 3 weeks after injection. Results: The interim results 6 months after injection are reported. At week 24, the mean improvement in WSRS from baseline was 0.83 ± 0.51 for Emervel Classic, similar to that for Restylane (0.90 ± 0.57). A similar volume of both fillers was injected. Most local tolerability events were mild and transient. Erythema, oedema/swelling and pain/tenderness were significantly less severe and disappeared faster with Emervel Classic than with Restylane (at least p < 0.05). Conclusion: Emervel Classic provides similar efficacy and better overall local tolerability compared with Restylane 6 months after treatment of moderate nasolabial folds.