A Multicenter, Randomized, Evaluator-Blinded Study to Examine the Safety and Effectiveness of Hyaluronic Acid Filler in the Correction of Infraorbital Hollows.

BACKGROUND: Hyaluronic acid injections are increasingly used for correction of infraorbital hollows (IOHs). OBJECTIVES: Examination of effectiveness (IOH correction) and safety of Restylane® EyelightTM hyaluronic acid (HAEYE, Galderma, Uppsala, Sweden) injections. METHODS: Subjects with moderate/severe IOHs, assessed using the Galderma infraorbital hollows scale (GIHS), were randomized to HAEYE injections (via needle/cannula) (Day 1+optional Month-1 touch up) or no-treatment control. Primary endpoint was blinded evaluator-reported Month-3 response, defined as ≥1-point GIHS improvement from baseline (both sides, concurrently). Other endpoints examined investigator-reported aesthetic improvement (GAIS), subject-reported satisfaction (FACE-Q™ satisfaction with outcome; satisfaction questionnaire), and adverse events. RESULTS: Overall, 333 subjects were randomized. Month 3 GIHS responder rate was significantly higher with HA-EYE (87.4%) versus control (17.7%; p<0.001), and comparable between HA-EYE-needle and HA-EYE-cannula groups (p=0.967). HAEYE GAIS responder rate was 87.5-97.7% (Months 3-12). Mean FACE-Q Rasch-transformed scores were 64.3-73.5 (HAEYE) versus 14.1-16.2 (control) through Month 12. Subjects reported looking younger (≥71%) and less tired (≥79%) with reduced under-eye shadows (≥76%) and recovered within 3-5 hours, post-treatment. Efficacy was maintained through Month 12 (63.5% GIHS responders) and through Month 18, after Month-12 retreatment (80.3% GIHS responders; 99.4% GAIS responders; FACE-Q scores: 72.5-72.8). Forty subjects (12.7%) reported typically mild adverse events (4.9% HAEYE-needle; 20.9% HAEYE-cannula). CONCLUSION: HAEYE treatment was effective in correcting moderate/severe IOHs at the primary endpoint (Month 3). Efficacy was sustained through Month 12 after first treatment for 63.5% and through Month 18 for 80.3% (after one retreatment) with needle or cannula administration. Safety outcomes were reassuring.

PrabotulinumtoxinA for Treatment of Millennials With Moderate to Severe Glabellar Lines: Post Hoc Analyses of the Phase III Clinical Study Data.

BACKGROUND: The use of esthetic products by millennials is increasing, yet published clinical trial data in this population are limited. OBJECTIVE: To compare the efficacy and safety of prabotulinumtoxinA for the treatment of moderate to severe glabellar lines in millennial and nonmillennial patients. METHODS AND MATERIALS: Post hoc analyses were performed on the pooled population of all patients treated with 20U prabotulinumtoxinA in the 3 single-dose Phase III glabellar line clinical studies. Patients were grouped by age: millennials (born 1982-2000) versus nonmillennials (born ≤1981). One key efficacy end point was the proportion of responders with a ≥1-point improvement from baseline at maximum frown on the 4-point Glabellar Line Scale. Adverse events were also summarized. RESULTS: Responder rates among millennials (n = 65) were greater than those of nonmillennials (n = 668) by 7.7% on average across all visits; differences were statistically significant at Day 90. Responder rates at Day 90 were 90.2% and 76.1%, respectively (absolute difference of 14.0%, p = .01). Headache was the most common treatment-related adverse event, occurring in 9.0% and 9.4% of millennials and nonmillennials, respectively. CONCLUSION: A single dose of 20U prabotulinumtoxinA administered for the treatment of glabellar lines was similarly well-tolerated by both millennials and nonmillennials; overall, it was more efficacious in millennials.

The First of Two One-Year, Multicenter, Open-Label, Repeat-Dose, Phase II Safety Studies of PrabotulinumtoxinA for the Treatment of Moderate to Severe Glabellar Lines in Adult Patients.

BACKGROUND: PrabotulinumtoxinA is a 900-kDa botulinum toxin type A produced by Clostridium botulinum. OBJECTIVES: The authors sought to investigate the safety of prabotulinumtoxinA for treatment of glabellar lines. METHODS: This was a multicenter, open-label, repeat-dose, 1-year phase II safety study. Adults with moderate to severe glabellar lines at maximum frown, as assessed by the investigator on the validated 4-point photonumeric Glabellar Line Scale (0 = no lines, 1 = mild, 2 = moderate, 3 = severe), were enrolled. On day 0, patients received an initial treatment of 20 U prabotulinumtoxinA (4 U/0.1 mL freeze-dried formulation injected into 5 target glabellar sites). On and after day 90, patients received a repeat treatment (RT) if their Glabellar Line Scale score was ≥2 at maximum frown by investigator assessment. Safety was evaluated throughout the study. RESULTS: The 352 study patients received a median total dose of 60 U, that is, 3 treatments per year. Fifty-one patients (14.5%) experienced adverse events (AEs) assessed as possibly study drug related; 11.1% experienced study drug-related AEs after the initial treatment. With each RT, progressively lower percentages of patients experienced study drug-related AEs. Six patients (1.7%) experienced study drug-related AEs of special interest: 3 eyelid ptosis (0.9%), 2 speech disorder (0.6%), and 1 blepharospasm (0.3%). Seven patients (2.0%) experienced serious AEs; none were study drug related. Of the 2393 samples tested, 2 patients (0.6%) tested positive for antibotulinum toxin antibodies at a single postbaseline visit. CONCLUSIONS: The safety of RTs of 20 U of prabotulinumtoxinA for moderate to severe glabellar lines was first established in this early phase II study based on a broad range of outcomes.

Rates of Vascular Occlusion Associated With Using Needles vs Cannulas for Filler Injection.

Importance: Soft-tissue augmentation with skin fillers can be delivered with needles or microcannulas, but unwanted vascular occlusions are possible. Objective: To determine whether filler-associated vascular occlusion events of the face occur more often with injections performed with needles than with microcannulas. Design, Setting, and Participants: This retrospective cohort study included a random sample of board-certified dermatologists deemed eligible based on membership in relevant professional societies and attendance at relevant national professional meetings. Participants completed detailed forms in which they could enter deidentified data and volume statistics pertaining to patients undergoing filler procedures in their practices. Data were collected from August 2018 to August 2019. Exposures: Injectable fillers approved by the US Food and Drug Administration delivered via needles or microcannulas. Main Outcomes and Measures: The primary outcome measure was intravascular occlusion. Occlusion events were graded by severity (no sequelae, scar, and ocular injury or blindness). Results: A total of 370 dermatologists (mean [SD] years in practice, 22.3 [11.1] years) participated and reported 1.7 million syringes injected. The risk of occlusion with any particular filler type using needle or cannula never exceeded 1 per 5000 syringes injected. Overall, 1 occlusion per 6410 per 1-mL syringe injections was observed with needles and 1 per 40 882 with cannulas (P < .001). Of the 370 participants, 106 (28.6%) reported at least 1 occlusion. Multivariate analysis found that injections with cannula had 77.1% lower odds of occlusion compared with needle injections. Participants injecting fillers for more than 5 years had 70.7% lower odds of occlusion than those who were less experienced. For each additional injection per week, the odds of occlusion decreased by 1%, and 85% of occlusions had no long-term sequelae. Nasolabial folds and lips were most likely to be occluded, with mean severity level of occlusions highest at the glabella. Conclusions and Relevance: In this cohort study, filler injections with either needles or cannulas were associated with a very low risk of intravascular occlusion events. Moreover, the vast majority of such events were minor and resolved without scar or other injury. Injections with microcannulas were less often associated with occlusion events than injections with needles. Occlusion risk per syringe appeared decreased after the first few years of clinical practice and was also lower among those who more frequently inject fillers. Whether a needle or cannula is most appropriate for injection may depend on patient factors, anatomic site, and the type of defect being treated.

Retrospective review of delayed adverse events secondary to treatment with a smooth, cohesive 20-mg/mL hyaluronic acid filler in 4500 patients.

BACKGROUND: Recent publications have suggested an increased risk of delayed adverse events (DAEs) with a smooth, cohesive 20-mg/mL hyaluronic acid filler, Juvéderm Voluma (HA-V). OBJECTIVE: To examine the occurrence of HA-V DAEs and identify patterns and characteristics. METHODS: Charts from patients who received HA-V between February 1, 2009, and February 28, 2018 from 2 clinics were analyzed. RESULTS: In 4500 patients who received 9324 treatments with HA-V, 44 DAEs were identified, for a combined incidence of 0.98% per patient, 0.47% per treatment, and 0.23% per syringe. Patients with DAEs received a slightly larger cumulative amount of HA-V than those who did not. Delayed swelling and nodule formation were the most common reactions and occurred a median of 4 months after treatment, with an increase in frequency between October and January. About a third were preceded by an identifiable immunologic stimulus. DAEs were transient and resolved without incident. LIMITATIONS: The retrospective nature made it difficult to capture time to resolution or remember potential triggers. CONCLUSION: In this large, long-term, retrospective review, HA-V DAEs occurred at a rate of 0.98% per patient. Although the exact cause has yet to be elucidated, we hypothesize that an increase in fragmentation during the HA-V degradation process may trigger an inflammatory response after an immunologic trigger.

Microcannula Injection of Large Gel Particle Hyaluronic Acid for Cheek Augmentation and the Correction of Age-Related Midface Contour Deficiencies.

BACKGROUND: There is a growing trend toward the use of blunt-tip microcannulas for the treatment of midface volume loss with injectable hyaluronic acid. OBJECTIVE: To evaluate the safety and efficacy of large gel particle hyaluronic acid with lidocaine, injected with a blunt-tip microcannula, for cheek augmentation and the correction of age-related midface contour deficiency. MATERIALS AND METHODS: Sixty subjects with mild to substantial loss of midface fullness were treated to optimal correction. Adverse events (AEs) were obtained during each examination visit. Efficacy was evaluated using the Global Aesthetic Improvement Scale, the Medicis Midface Volume Scale (MMVS), and the FACE-Q subject satisfaction questionnaire through 16 weeks. RESULTS: Five AEs were reported, with only one being considered injection procedure-related (mild presyncope). No serious AEs were reported. Global aesthetic improvements were reported for the majority of subjects (≥98.3% for investigator-assessed and ≥91.5% for subject-assessed) for up to 16 weeks. At 8 weeks, the MMVS responder rate was 100% and subject satisfaction scores (5/6 questions) in the FACE-Q were ≥91.5%. CONCLUSION: Hyaluronic acid with lidocaine, injected with a blunt-tip microcannula, has a favorable safety profile and is effective up to 16 weeks for cheek augmentation and the correction of age-related midface contour deficiencies (NCT03160716).

Ten-Year and Beyond Follow-up After Treatment With Highly Purified Liquid-Injectable Silicone for HIV-Associated Facial Lipoatrophy: A Report of 164 Patients.

BACKGROUND: Highly purified liquid-injectable silicone (LIS) has been established as a permanent agent for off-label correction of HIV-associated facial lipoatrophy (HIV-FLA). However, controversy exists about long-term safety. OBJECTIVE: To establish the safety and efficacy at 10 years or greater of LIS for HIV-FLA. METHODS: Patients from 3 practices with 10-year or greater in-person office follow-up were analyzed to determine the number of LIS treatments and total volume required to achieve optimal correction. The nature of any treated adverse events was noted. RESULTS: One hundred sixty-four patients had 10-year or greater in-office follow-up. All subjects maintained long-term correction with an average of 9 treatments, average of 1.56 mL per treatment, and an average total of 14.1 mL. Two patients had severe adverse events manifesting as temporary facial edema. Four patients experienced mild-to-moderate excess fibroplasia presenting as perceived overcorrection, and 6 patients had nondisfiguring subcutaneous firmness. All adverse events were successfully treatable, mostly with intralesional 5-fluorouracil and triamcinolone. CONCLUSION: Liquid-injectable silicone is an effective long-term treatment option for HIV-FLA. When injected in small quantities with the microdroplet serial puncture technique at monthly or greater intervals, optimal correction appears durable for more than 10 years. Adverse events consisted mostly of excess fibroplasia and were treatable.

Self-reported Patient Motivations for Seeking Cosmetic Procedures.

Importance: Despite the growing popularity of cosmetic procedures, the sociocultural and quality-of-life factors that motivate patients to undergo such procedures are not well understood. Objective: To estimate the relative importance of factors that motivate patients to seek minimally invasive cosmetic procedures. Design, Setting, and Participants: This prospective, multicenter observational study was performed at 2 academic and 11 private dermatology practice sites that represented all US geographic regions. Adult patients presenting for cosmetic consultation or treatment from December 4, 2016, through August 9, 2017, were eligible for participation. Exposures: Participants completed a survey instrument based on a recently developed subjective framework of motivations and a demographic questionnaire. Main Outcomes and Measures: Primary outcomes were the self-reported most common motivations in each quality-of-life category. Secondary outcomes were other frequently reported motivations and those associated with specific procedures. Results: Of 529 eligible patients, 511 agreed to participate, were enrolled, and completed the survey. Typical respondents were female (440 [86.1%]), 45 years or older (286 [56.0%]), white (386 [75.5%]), and college educated (469 [91.8%]) and had previously received at least 2 cosmetic procedures (270 [52.8%]). Apart from motivations pertaining to aesthetic appearance, including the desire for beautiful skin and a youthful, attractive appearance, motives related to physical health, such as preventing worsening of condition or symptoms (253 of 475 [53.3%]), and psychosocial well-being, such as the desire to feel happier and more confident or improve total quality of life (314 of 467 [67.2%]), treat oneself or celebrate (284 of 463 [61.3%]), and look good professionally (261 of 476 [54.8%]) were commonly reported. Motivations related to cost and convenience were rated as less important (68 of 483 [14.1%]). Most motivations were internally generated, designed to please the patients and not others, with patients making the decision to undergo cosmetic procedures themselves and spouses seldom being influential. Patients younger than 45 years were more likely to undertake procedures to prevent aging (54 of 212 [25.5%] vs 42 of 286 [14.7%] among patients ≥45 years; P < .001). Patients seeking certain procedures, such as body contouring (19 of 22 [86.4%]), acne scar treatment (36 of 42 [85.7%]), and tattoo removal (8 of 11 [72.7%]), were more likely to report psychological and emotional motivations. Conclusions and Relevance: This initial prospective, multicenter study comprehensively assessed why patients seek minimally invasive cosmetic procedures. Common reasons included emotional, psychological, and practical motivations in addition to the desire to enhance physical appearance. Differences relative to patient age and procedures sought may need further exploration.

Evaluating the Efficacy of Different Platelet-Rich Plasma Regimens for Management of Androgenetic Alopecia: A Single-Center, Blinded, Randomized Clinical Trial.

BACKGROUND: Studies suggest platelet-rich plasma (PRP) may mitigate androgenetic alopecia (AGA), but each varies in the frequency of and interval between treatments. OBJECTIVE: To compare the efficacy, satisfaction, tolerability, and safety of 2 initial PRP injection protocols over 6 months. METHODS: Prospective, randomized, single-blinded trial among 40 patients with moderate AGA. Participants received subdermal PRP injections according to 1 of 2 treatment protocols: 3 monthly sessions with booster 3 months later (Group 1) or 2 sessions every 3 months (Group 2). Folliscope hair count and shaft caliber, global photography, and patient satisfaction questionnaires were obtained at baseline, 3 months, and 6 months. RESULTS: At 6 months, both groups demonstrated statistically significant increases in hair count (p < .001). These improvements occurred more rapidly and more profoundly for Group 1 (mean percent change: Group 1, 29.6 ± 13.6 vs Group 2, 7.2 ± 10.4; p < .001). Shaft caliber also increased significantly with no difference between groups. Treatments produced high satisfaction (82% "satisfied" or "highly satisfied") and were safe and well tolerated (mean pain score 2.1). CONCLUSION: Subdermal PRP injections are an efficacious and tolerable therapy among men and women with AGA. The benefits may be greater if first administered monthly. Clinicians should consider these findings when designing treatment plans.