A Randomized, Controlled, Evaluator-Blinded, Multi-Center Study of Hyaluronic Acid Filler Effectiveness and Safety in Lip Fullness Augmentation.

BACKGROUND: HARK was recently approved in the US for lip augmentation and correction of upper perioral rhytids. OBJECTIVE: To demonstrate noninferiority of HARK versus a control (HAJV) in lip fullness augmentation at Week 8 after last injection (blinded evaluation). Secondary objectives were to evaluate the effectiveness and safety of HARK in lip fullness augmentation and correction of upper perioral rhytids. METHODS AND MATERIALS: Treatment with HARK or control (randomized 2:1) was administered on Day 1 in this 48-week, evaluator-blinded study with optional touch-up at Week 4. Primary endpoint was change from baseline to Week 8 in lip fullness. Secondary endpoints included lip fullness, wrinkle severity, aesthetic improvement, subject satisfaction, adverse events, and local tolerability (subject diary entries). RESULTS: The primary objective was met; HARK was noninferior to control in lip fullness augmentation at Week 8. Lip fullness and wrinkle severity improvement persisted at Week 48, and was accompanied by high aesthetic improvement and subject satisfaction scores. The mean volume of HARK injected was approximately 20% lower than control. Treatment-related adverse events and local tolerability symptoms were predominantly mild and transient. CONCLUSION: HARK was noninferior to control in lip fullness augmentation at Week 8, well-tolerated, and effective throughout this 48-week study.

Surgical and Nonsurgical Techniques in Forehead Rejuvenation.

The periorbital and forehead regions are among the most expressive parts of the face. A thorough understanding of the complex facial anatomy and aesthetic norms are essential when evaluating and treating a patient for facial brow rejuvenation. Not only will knowledge of the anatomy enhance facial injection and surgical outcomes, but will also diminish potential complications. Combining nonsurgical and surgical techniques, including laser and skin rejuvenation, can yield the most natural and effective aesthetic brow improvements.

Injectable poly-L-lactic acid for human immunodeficiency virus-associated facial lipoatrophy: cumulative year 2 interim analysis of an open-label study (FACES).

BACKGROUND: Studies of injectable poly-L-lactic acid (PLLA) in human immunodeficiency virus (HIV)-associated facial lipoatrophy have predominantly included male Caucasians. OBJECTIVE: To report cumulative year 2 interim study results examining the safety and efficacy of injectable PLLA in subjects with HIV categorized according to Fitzpatrick skin type and sex. MATERIALS AND METHODS: This is an ongoing open-label, multicenter, 5-year study of 290 treated subjects. After correction with injectable PLLA, subjects are being followed annually. Primary end points include incidence and severity of treatment-emergent adverse events (TEAEs). Secondary end points include mean change from baseline of James scale severity grade and treatment satisfaction. RESULTS: At 2 years, TEAE incidences were: potentially related to study product (n = 53,18.3%) or injection procedure (n = 71, 24.5%), injection-site nodules (n = 24, 8.3%) and papules (n = 25, 8.6%). No hypertrophic scars, keloids, or product-related serious TEAEs were reported. Mean improvement in James scale grade for all groups was 1.4 (p < .001), and 89.4% of subjects and 95.5% of physicians rated treatment satisfaction as very good or excellent. CONCLUSION: At 2 years, injectable PLLA is a safe and effective long-term treatment for HIV-associated facial lipoatrophy regardless of Fitzpatrick skin type; confirmation of these results will be needed at the completion of this 5-year study.

Safety and effectiveness of small and large gel-particle hyaluronic acid in the correction of perioral wrinkles.

BACKGROUND: FDA-approved for the correction of moderate-to-severe facial wrinkles and folds, small gel-particle hyaluronic acid (SGP-HA, Restylane, Medicis Aesthetics, Inc., Scottsdale, AZ) and large gel-particle hyaluronic acid (LGP-HA, Perlane, Medicis Aesthetics, Inc., Scottsdale, AZ) were studied to evaluate their safety for the correction of oral commissures, marionette lines, upper perioral rhytides and nasolabial folds (NLFs). OBJECTIVES: The primary objective of this study was to investigate the safety of SGP-HA and LGP-HA in treating facial wrinkles and folds around the mouth; the secondary objective was to evaluate the effectiveness of these products. METHODS: This open-label, 4-week study at two US centers evaluated SGP-HA and LGP-HA in patients who intended to undergo intradermal injection for correction of of perioral wrinkles and folds. At screening, a 5-grade Wrinkle Severity Rating Scale (WSRS) was used to evaluate the baseline appearance of bilateral NLFs, and a 6-grade Wrinkle Severity (WS) scale was used to evaluate the appearance of bilateral oral commissures, marionette lines and upper perioral rhytides. To qualify, each patient must have had moderate-to-severe wrinkles at one pair of marionette lines and upper perioral rhytides. Each wrinkle was treated to optimal correction with either SGP-HA or LGP-HA at the discretion of the treating investigator. All reported local and systemic adverse events (AEs) were recorded. At two weeks after treatment or touch-up, the treating investigator and the patient assessed appearance using the Global Aesthetic Improvement Scale (GAIS). RESULTS: Twenty patients with a mean age of 59.6 years (range 49 to 65 years) were treated with an average of 5.58 plus minus 1.15 mL of HA for the entire perioral area. Treatment areas included NLFs, marionette lines, oral commissures and perioral rhytides. Eighteen of 20 patients received both SGP-HA and LGP-HA. Product was injected into the mid or deep dermis using primarily linear threading and multiple punctate pools. Patients experienced a total of 66 treatment-emergent AEs (TEAEs); each patient experienced at least one TEAE. The reported events in decreasing order of occurrence were bruising, tenderness, swelling, redness, headache and discomfort. Bruising was more common in the NLFs and marionette lines than in the oral commissures and perioral rhytides. Tenderness occurred more often in the perioral rhytides than in the other areas. The maximum intensity of all TEAEs was considered mild. Most TEAEs resolved within seven days, with an average duration of four days. No serious TEAEs occurred during the study. One hundred percent of GAIS evaluations by both investigators and patients indicated improvement, regardless of filler used or area treated. CONCLUSION: Both SGP-HA and LGP-HA were found to be safe and effective for the correction of perioral wrinkles and folds, with few differences among treatment areas Both investigator and patient GAIS evaluations indicated aesthetic improvement after SGP-HA and LGP-HA treatment in the perioral area.

Volumetric facelift with intra- and post-operative midface volume replacement "the four-dimensional facelift".

Cosmetic rejuvenation of the lower face can be accomplished effectively with facelift surgery; however, aesthetic outcomes are significantly improved when surgical traction combined with midface volume restoration is achieved and perpetuated. Incorporating the current understanding of the evolving process of facial maturation, this article puts forth an approach to full-face rejuvenation involving the continued treatment of the facelift patients with injectable filler materials for years after the surgical procedures. Beyond a three-dimensional approach, this "four-dimensional" method can achieve persistent, effective, natural-appearing outcomes that can be maintained successfully and dynamically over time.

Facial dermal fillers: selection of appropriate products and techniques.

Over the last decade, there has been a shift in the way aesthetic surgeons approach facial rejuvenation. With recognition of the value of volume enhancement in achieving a more youthful appearance, as well as the ease of office procedures offering minimal downtime and predictable results, there has been a concomitant explosion in the soft tissue filler market. Given the vast array of filler products currently available, the decision of which facial filler to use in specific situations can be complicated and confusing. A physician's selection of facial filler(s) should be based on a solid understanding of the various filler products, appropriate patient selection, and the physician's proficiency in injection techniques. We present a review of the most widely used fillers, offering guidance on patient selection and effective injection techniques.

The use of Botox to treat glabellar rhytids.

The goal of the article is to allow a physician to become more familiar with Botox as a treatment of glabellar wrinkles. An overview of the anatomy of that region is reviewed. Evaluation of the facial muscles before treatment and injection technique is also covered.

Brown recluse spider bites to the head: three cases and a review.

Consequences of envenomation from the bite of a brown recluse spider (Loxosceles reclusa) range from mild itching to death. The bite of this spider causes the most severe form of arthropod-induced tissue necrosis. These bites pose several challenges to the clinician in that diagnosis can be difficult, systemic manifestations can occur, and healing can be resistant to conventional measures. Bites to the head and neck-particularly the face-are uncommon, and they have not been widely reported in the otolaryngology literature. As experts in facial soft tissue, otolaryngologists and facial plastic surgeons should be able to recognize and treat these lesions. Because no laboratory test is available to identify the cause of symptoms in these cases, the diagnosis is made clinically. Early intervention can make a significant difference in cosmetic outcome, so a high index of suspicion is warranted. Local wound care includes rest, ice, compression, and elevation of the affected part of the body. Drug therapy with dapsone may limit the severity of the bite and prevent complications. Because some bites cause systemic loxoscelism, clinicians should be familiar with its manifestations. When necrosis occurs despite adequate medical treatment, reconstructive procedures should be delayed until healing is complete. We report 3 cases of brown recluse spider bites to the head. These cases illustrate the broad spectrum of the disease course, and they highlight the therapeutic challenges that these lesions pose.

Use of a nonablative radiofrequency device to rejuvenate the upper one-third of the face.

OBJECTIVE: To evaluate the use of the ThermaCool TC nonablative radiofrequency device for rejuvenation of the upper one-third of the face, as determined by brow elevation. Study design and setting Twenty-four patients in a facial plastic surgery office were treated with the nonablative radiofrequency device. The patients had pretreatment photos, in-office procedure, and follow-up photos. Brow elevation measurements were used to gauge efficacy of the procedure. These results were compared to an untreated, control group of 12 patients. RESULTS: Compared to the control group, the post-treatment measurements were improved (P < 0.05). The post-treatment measurements were also improved from pretreatment baseline (P < 0.05). Subjective results obtained from patient satisfaction questionnaires did not correlate to the objective data. The data also showed that improvement in brow elevation was not uniform in each patient. CONCLUSION: The ThermaCool TC nonablative radiofrequency device for in-office rejuvenation of the upper one-third of the face procedure does provide brow elevation in a majority of patients; however, the majority of the study patients did not perceive benefit from the procedure. Patient satisfaction in facial plastic surgery must be an important part of the decision of whether or not to introduce a new device into a practice setting.

Use of the KTP laser in the treatment of rosacea and solar lentigines.

Numerous techniques have evolved in facial plastic surgery to treat rosacea and solar lentigines. The treatment regimens range from avoidance of causative factors to the use of topical agents or other modalities that target the superficial layers of the skin. Of the modalities that target the epidermis, lasers offer the physician and patient the ability to target specific chromophores in the skin. Advances in laser technology led to the implementation of targeting certain characteristic pigments of abnormal areas with minimal damage to surrounding normal tissue. Rosacea and solar lentigines have characteristic cells that are targeted by a potassium-titanyl-phosphate (KTP) laser. The lesions are different in their origins but share the ability to be treated successfully with the KTP laser. A review of both conditions and other treatment options is discussed.

Deep-plane face-lift vs superficial musculoaponeurotic system plication face-lift: a comparative study.

OBJECTIVE: To evaluate deep-plane face-lift vs superficial musculoaponeurotic system (SMAS) plication face-lift in correcting the melolabial fold, jowl, and cheek areas of the face in short-term follow-up. DESIGN: Masked, randomized review by 4 board-certified facial plastic surgeons experienced in rhytidectomy of full-face (frontal, oblique, and lateral views) before-and-after photographs of 20 patients who underwent deep-plane face-lift and 20 who underwent SMAS plication face-lift. Participants rated the melolabial fold, jowl, and cheek areas for overall correction of the deformities pertaining to the aesthetic results for deep-plane vs SMAS plication face-lift. Categories were excellent, good, average, acceptable, and poor. RESULTS: Three categories of results were determined: best, average, and poorest. Overall, SMAS plication face-lifts scored higher than deep-plane face-lifts. In the best category, there were more SMAS plication face-lifts. In the average category, there were more deep-plane face-lifts. In the poorest category, there were equal numbers of deep-plane and SMAS face-lifts. Patients were divided into the following age groups: 50 to 59, 60 to 69, and 70 to 80 years. In the 2 younger groups, SMAS face-lifts scored higher than deep-plane face-lifts. In the oldest group, deep-plane face-lifts scored slightly higher than SMAS face-lifts. CONCLUSION: Deep-plane face-lift does not seem to offer superior results over SMAS plication face-lift in patients younger than 70 years.

Foreign-body inclusion cyst presenting on the lateral nasal sidewall 1 year after rhinoplasty.

Hemostasis and decreased risk of synechiae formation are benefits of nasal packing after sinus surgery; however, these must be weighed against the possible complications, which can include devastating toxic shock syndrome. Nasal packing is often impregnated with an ointment that allows for a less traumatic placement into and removal from the nasal cavity, as well as providing some antibiotic coverage for nasal bacterial flora. Orbital complications secondary to the petroleum-based packing have been reported. When sinus surgery is performed in conjunction with a rhinoplasty, there is a possibility of petroleum ointment migrating into intranasal incisions or osteotomy sites. A 15-year-old girl was examined 1 year after endoscopic sinus surgery combined with an open rhinoplasty had been performed at another institution. Physical examination showed a widened nasal dorsum with an open-roof deformity and a 1-cm firm mass lateral to her lateral nasal sidewall. The pathological examination after removal of the cyst showed a foreign-body inclusion cyst or lipogranuloma. The cyst contained a petroleum-based substance.

The use of Botox to treat glabellar rhytids.

Many areas of the face benefit from Botox. The deep vertical and horizontal creases between the eyebrows or glabellar area are the best known to cosmetically improve with Botox injections. As with almost any cosmetic procedure, adequate evaluation and pre-operative assessment can lead to a good outcome and a satisfied patient.

Dry mouth and nose in the older patient. What every PCP should know.

Dry mouth and dry nose are common complaints among the older population. Dry mouth can be attributed to medical conditions and other underlying causes, whereas dry nose is usually associated with age-related changes in nasal physiology and structure. In both cases, medications can contribute to dryness, so a proper evaluation includes a careful drug review. Management of dry mouth includes hydration and use of mouthwash, sugarless gum, candy, and saliva substitutes. Dry nose can be managed with nasal sprays that moisten the nasal cavity.