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.

From Nasolabial Folds to Pan-facial Rejuvenation-The Evolution of Fillers in my Career.

This is a comprehensive review of facial fillers including landmark studies and expert commentary spanning the years from 2003 (when the first hyaluronic acid [HA] dermal filler underwent Food and Drug Administration approval in United States) to present.

One-Year Data on the Longevity and Safety of Hyaluronic Acid Filler for Static Horizontal Neck Rhytids.

BACKGROUND: The long-term efficacy and safety of hyaluronic acid fillers injected into the neck have yet to be analyzed in a prospective trial in the United States. OBJECTIVE: Analyze the long-term efficacy and safety of a hyaluronic acid filler for static horizontal neck rhytids. MATERIALS AND METHODS: Twenty-six subjects were enrolled in the study. Six subjects were randomized to receive saline and 20 subjects were randomized to receive HA RR. All subjects were randomized to use a cannula on 1 side and needle on the other with optional retreatment on day 30 and optional crossover treatment with different assignment on day 60. The subjects were graded using the Transverse Neck Line Scale, Canfield photography, and the Global Aesthetic Improvement Scale on day 360. RESULTS: A significant improvement from baseline on day 360 was achieved on the Transverse Neck Line Scale according to the blind evaluator, subjects, and investigator without any delayed-onset or prolonged side effects. There was no significant difference in the average improvement from the short-term analysis on day 60 to the long-term analysis on day 360. CONCLUSION: HA RR achieved significant long-term improvement in static horizontal neck rhytids without any long-term side effects.

Actinomyces: An Under Appreciated Cause of Postoperative Infection in Rhinoplasty.

OBJECTIVE: To discuss a case series of Actinomyces infection post-rhinoplasty and review the literature for correct diagnosis and management. STUDY DESIGN: Case series with chart review. METHODS: Three cases are presented of patients with a history of recurrent infectious symptoms post revision rhinoplasty later being diagnosed as Actinomyces. RESULTS: Three patients were identified having undergone revision rhinoplasty and later being diagnosed with Actinomyces infection. They initially presented with underwhelming physical exams, mild erythema, slight swelling, yet extreme pain. They also had periods of recurrent infection once antibiotics were stopped. Aerobic, anaerobic, fungal, and Actinomyces cultures were sent to pathology and returned positive for Actinomyces. Treatment typically involved a combination of prolonged antibiotics, incision and drainage, and/or surgical debridement. CONCLUSIONS: Awareness of Actinomyces as a possible cause of infection post-rhinoplasty is significant as this pathogen can lead to extensive tissue destruction and fistula formation which could be detrimental for a rhinoplasty. Duration of treatment is beyond typical lengths for other infections and a specific culture for Actinomyces is required to be sent as it isn't captured in standard aerobic/anaerobic cultures. Therefore, a high index of suspicion is required by physicians to ensure that patients are evaluated thoroughly. Laryngoscope, 133:2948-2950, 2023.

Cosmetic Filler and PET Positivity: The Risk of a False Positive.

OBJECTIVE: To discuss a case of hyaluronic acid filler displaying as PET avid resulting in a false positive for local recurrence and review of the literature of how filler presents on PET. STUDY DESIGN: Case report and literature review. METHODS: Retrospective case review of a patient with angiosarcoma with PET-MRI positivity after hyaluronic acid filler injection. Review of the literature was performed. RESULTS: A 49-year-old female with low grade angiosarcoma of the right cheek pT1N0M0 was treated with wide local excision and staged reconstruction with cervicofacial advancement flap with subsequent adjuvant radiation therapy. Surveillance PET/MRI scans were conducted every 3 months. After one year without recurrence, HA injectable filler was offered to correct resultant right facial soft tissue defect. The patient proceeded with HA filler and was counseled on the risk of local increased SUV on imaging. Her PET/MRI 3 months later revealed postsurgical changes in the right premaxillary soft tissues with associated low-grade hypermetabolism with max SUV 1.8, which elevated from prior max SUV 0.9. Contralateral left maxillary soft tissues revealed max SUV 0.8. Biopsy was initially favored for concern of local recurrence until the potential for filler to be associated with elevated SUV was discussed. Further evaluation with MRI showed diffusely increased T2 signal with some trace enhancement in the region of PET activity, confirming that findings were consistent with HA filler augmentation per the neuroradiologist team. CONCLUSIONS: Fillers, including hyaluronic acid, are associated with elevated SUV on PET-CT. Otolaryngologists should be aware of these features to improve patient counseling, avoid unnecessary procedures, and reduce patient anxiety. Laryngoscope, 133:2951-2953, 2023.

A split-face, blind, randomized placebo-controlled clinical trial investigating the efficacy and safety of hyaluronic acid filler for the correction of atrophic facial scars.

BACKGROUND: Hyaluronic acid fillers have been studied extensively for facial wrinkles; however, their efficacy for atrophic facial scars has yet to be analyzed in a prospective placebo-controlled study. OBJECTIVE: To analyze the efficacy and safety of a hyaluronic acid filler for atrophic facial scars. METHODS & MATERIALS: Fifteen subjects were randomized to receive up to 1 ml of VYC-17.5 L on one cheek and up to 1 ml of saline on the other side, with an optional touch-up treatment. Subjects were graded by a live blind evaluator using the Quantitative Global Scarring Grading System (QGSGS) (J Cosmet Dermatol. 2006;5:48), the Global Aesthetic Improvement Scale (GAIS), and Canfield photo-analysis. RESULTS: According to the blind evaluator, there was a significant reduction 90 days after the last treatment on the QGSGS for VYC-17.5L compared with saline (-6.6 VYC-17.5L vs -1.7 saline [t(28) = -4.3196, p = 0.008]). There was a smaller, but still significant reduction on the QGSGS for saline alone (10.4 to 8.6 [t(14) = -3.453, p = 0.004]). In addition, 93% (13/14) of subjects chose VYC-17.5L over saline treatment and reported an improvement on the GAIS. There were no serious side effects and all minor side effects resolved by Day 30. CONCLUSION: VYC-17.5L achieved significant improvements in rolling atrophic scars as compared to saline, though saline also had modest improvements.

A Randomized, Placebo-Controlled, Split-Neck Trial of Hyaluronic Acid Filler for Static Horizontal Neck Rhytides Using Either a Cannula or Needle.

BACKGROUND: Hyaluronic acid (HA) fillers have been studied extensively on the face; however, their safety and efficacy on the neck has not yet been evaluated in a prospective trial in the United States. OBJECTIVE: Analyze the efficacy and safety of a HA filler for static horizontal neck rhytides using either a cannula or needle. MATERIALS AND METHODS: Twenty-six subjects were randomized to receive up to 1 mL of the HA filler Restylane Refyne (HARR, n = 20) or saline (n = 6) using a cannula on one side and a needle on the other with optional repeat treatment. Subjects were graded using the Transverse Neck Line Scale, Canfield photography, and the Global Aesthetic Improvement Scale. RESULTS: A significant improvement 30 days after the last treatment was achieved on the Transverse Neck Line Scale when comparing HARR with saline according to the blind evaluator, subjects, and investigator without any significant side effects. In addition, the blind evaluator, subjects, and investigator rated the side of the neck injected with a needle as having significantly greater improvement than the cannula. CONCLUSION: The hyaluronic acid filler, Restylane Refyne, achieved significant improvement in static horizontal neck rhytides using either a cannula or needle without any serious side effects, although the needle was more effective.

Lip and Perioral Trauma: Principles of Aesthetic and Functional Reconstruction.

Successful management of lip and perioral trauma requires a nuanced understanding of anatomy and surgical techniques. Surgical correction is particularly challenging in instances of tissue loss, due to a narrow tolerance for aesthetic deformity and highly specialized functions of the perioral region, including facial expression, communication, and oral competence. Restoring continuity of the orbicularis oris musculature is critical for dynamic sphincter function of the upper and lower lips. Lip and perioral tissue symmetry are also critical for aesthetic balance, and failure to restore a natural appearance can adversely affect personal identity, with attendant psychological trauma. This discussion of lip and perioral trauma management encompasses lip and perioral anatomy, evaluation of injuries, reconstructive techniques, and prevention and management of complications. Perioral injuries are classified by size, depth, and extent of injury, and the corresponding reconstructive approaches are a function of complexity. These approaches proceed sequentially up rungs of the reconstructive ladder including primary repair, local flaps, grafting, regional flaps, as well as microvascular free tissue transfers. Procedures may be single stage or require multiple stages or subsequent refinement. Regardless of the defect size or location, the guiding principle of repair in the perioral region is restoring natural function and aesthetic appearance. This still-evolving area of facial plastic and reconstructive surgery lends itself to artistry and technical precision, offering opportunities for further innovation to improve the outcomes of patients with lip and perioral trauma.

Evaluating New Technology.

There are multiple complex issues to consider when evaluating any new technology. First evaluate the efficacy of the device. Then considering your patient population decide whether this technology brings an added benefit to your patients. If it meets these 2 criteria, then proceed to the financial analysis of acquiring this technology. The complete financial analysis has several important components that include but are not limited to cost, value, alternatives, return on investment, and associated marketing expense.

Split face evaluation of long-pulsed non-ablative 1,064 nm Nd:YAG laser for treatment of direct browplasty scars.

PURPOSE: To investigate 1,064 nm long-pulse Nd:YAG laser for postoperative treatment of direct browplasty scars. METHODS: Nine patients who underwent direct browplasty were enrolled in this prospective study. Subjects were randomized to unilateral laser treatment at 2-week intervals for six total treatments, with the contralateral scar used as a control. Prior to each treatment, subjects rated treated and control scars on overall cosmesis. Post-treatment, subjects rated each for erythema, swelling, discomfort, and perceived hair loss. Finally, examiners masked to treatment side were asked to judge side-by-side photographs of first and final visits for improvement and side effects. RESULTS: Subjects rated the overall appearance of the treated scar significantly higher at the time of treatment number 5 (mean score 5.13 ± 2.03, P = 0.008) and treatment number 6 (6.25 ± 1.98, P = 0.005) compared to treatment 1 (3.75 ± 2.12); by contrast, they failed to rate the control scar more highly. On masked examination of photographs, the treated scar was selected as most improved 50.0 ± 12.5% of the time. Both subjects and graders reported side effects as transient and mild to moderate (mean score 1-4), with no reports of hair loss from either subjects or observers. CONCLUSIONS: The 1,064 nm Nd:YAG laser provided significant improvement in scar cosmesis after direct browplasty, as rated by subject self-report, but not by masked observers, and appears to be a useful tool for increasing satisfaction among those dissatisfied with direct browplasty scars. Side effects-including erythema, edema, and discomfort-were transient and universally rated as mild to moderate. Lasers Surg. Med. 48:742-747, 2016. © 2016 Wiley Periodicals, Inc.

The role of neurotoxins in the periorbital and midfacial areas.

Initially popularized for the treatment of strabismus and blepharospasm, injection of botulinum neurotoxin has become the most commonly performed cosmetic treatment in the United States. Injection techniques have been particularly well-studied in the midface and periocular region, and patient satisfaction tends to be very high. We review the salient differences among available neurotoxins, how to optimally reconstitute them, how to inject the forehead, glabella, lateral canthal lines ("crow's feet"), infralid region, and transverse nasal lines ("bunny lines"), how to sculpt the brow, and how to manage potential complications.

Nonprescription topical treatments for skin rejuvenation.

Topical skin care regimens are a mainstay treatment for aging skin. All patients seeking skin rejuvenation can benefit from this low-risk intervention. This article reviews available nonprescription topical treatments for rejuvenation including moisturizers, antioxidants, retinols, and sunscreen.

Neurotoxins and fillers for skin rejuvenation.

The ephemeral effects of neurotoxins and fillers are well described for facial remodeling and rejuvenation. Less is known about their long-term effects on skin rejuvenation and neocollagenesis. This article aims to review current available science and literature to support the use of these cosmetic procedures as lasting antiaging treatments.

Cosmeceuticals for recurrence prevention after prior skin cancer: an overview.

INTRODUCTION: Skin cancer is the most common form of cancer in the United States. According to the World Health Organization, the incidence of both nonmelanoma and melanoma skin cancers has increased over the past few decades. OBJECTIVE: The objective of this article is to review studies about cosmeceuticals that can be used by people who previously had skin cancer and may work as agents that help in some way to prevent new skin cancer lesions. CONCLUSION: Cosmeceuticals are antiaging skin products that overlap cosmetics and pharmaceuticals and are commonly available over the counter. This article reviewed several substances used in cosmeceuticals formulations that could be useful for individuals who have had previous skin cancers and need to prevent possible new lesions. Further studies are needed to better evaluate these products and their skin cancer preventive properties.

Photoaging.

Treatments for photoaging are commonly requested by cosmetic patients. Laser resurfacing treatment addresses the myriad aspects of photoaging, including fine rhytides, dyspigmentation, and abnormal texture. Recent developments in laser medicine--such as fractional resurfacing in both ablative and non-ablative wavelengths--have improved the safety and side effect profile of laser resurfacing. Both ablative and non-ablative wavelengths are effective. The use of lasers should be limited to experienced practitioners to minimize the risks of scarring, pigment alterations, and other unwanted effects.

Laser treatment of skin texture and fine line etching.

Modern cosmetic medicine requires accurate recognition of all types of rhytids and their molecular causes such that treatments may be tailored for improving skin appearance for each unique patient. This article examines the causes and treatment of fine rhytids. Laser rejuvenation therapies that affect the epidermis, dermis or both and induce neocollagenesis and dermal remodeling can be effective against the stigmata of mature skin.

Laser treatment of facial scars.

PURPOSE OF REVIEW: Facial scars can develop as a result of trauma, surgery, burns, acne, or other conditions. These scars are often quite distressing to patients. Lasers were first used to treat these scars in the 1990s. Recently, new laser technology has been used to prevent and treat scars. This literature review and the report of the senior author's recent experience summarize the recent advances in laser treatment of scars. RECENT FINDINGS: With the development of new laser technology, the treatment options for hypotrophic scars and developing scars have increased. Furthermore, there are expanded options for treatment of established hypertrophic scars. Recent studies have shown that nonablative and fractionated lasers can be effective for treating hypotrophic and developing scars. Scar improvements may be due to direct effects of the laser and/or histochemical effects, including production of heat shock proteins and tumor growth factors. Nonablative and fractionated lasers have a shorter recovery period than CO2 resurfacing lasers. This can vary from a few hours to up to 7 days. SUMMARY: Recent new laser technology has increased the options for treatment of scars. These have been shown to be beneficial for hypotrophic, incipient, and established scars. The benefits of laser therapy may be due to direct and/or histochemical effects.

1550-nm nonablative laser resurfacing for facial surgical scars.

OBJECTIVE: To investigate the efficacy of 1550-nm (Fraxel SR1500 RE:Store; Solta Medical, Hayward, California) nonablative laser treatment of facial surgical scars. METHODS: In this prospective clinical study, a volunteer sample of 13 adults with Fitzpatrick skin types I to III and facial surgical scars with a postoperative duration longer than 6 months were enrolled. Subjects were treated once every 4 weeks for a total of 4 treatments. Initial settings for the 1550-nm nonablative laser were at energy level 40 mJ and treatment level 4 and were subsequently increased on each visit according to the patients' tolerance level. Using a previously validated Patient and Observer Scar Assessment Scale (POSAS), the study subject and an independent evaluator completed assessments of the scar at each visit. RESULTS: According to the Friedman test on ratings across all occasions after the first treatment to the last evaluation, there was a statistically significant improvement in the patient's assessment of the color, stiffness, thickness, and irregularity of the scar but not for pain or itching. For the observer's ratings, there was a statistically significant improvement in pigmentation, thickness, relief, and pliability but not for vascularization. CONCLUSIONS: Preliminary data suggest improved aesthetic results, demonstrating the potential use of fractional photothermolysis as a scar revision technique. Future studies with a longer follow-up period could elucidate the role of fractional photothermolysis in more permanent scar improvements.

Lip and perioral trauma.

The management of perioral injuries is a complex topic that must take into consideration the unique anatomy, histology, and function of the lips to best restore form and function of the mouth after injury. Basic reconstructive principles include three-layered closure for full-thickness lip lacerations. Additionally, special care is needed to ensure an aesthetic repair of the cosmetically complex and important vermillion border, philtrum, and Cupid's bow. Infraorbital and mental nerve blocks provide lip anesthesia for laceration repair without distorting crucial aesthetic landmarks. Prophylactic antibiotics are usually indicated in perioral injuries due to wound contamination with saliva. Perioral burn management is controversial; however, most lip burns can first be managed conservatively. Splinting, plasties, and other reconstructive options are available after secondary healing of perioral burns. Hypertrophic scars are common in the perioral area after trauma. The mainstays of treatment for hypertrophic scars on the lips are silicone elastomer sheeting and intralesional steroid injections. For large perioral defects, a myriad of reconstructive options are available, ranging from primary closure, cross-lip flaps, and local tissue transfer, to free tissue transfers such as radial forearm free flaps, innervated gracilis free flaps, anterolateral thigh free flaps, and osteocutaneous free flaps.