Stacy Smith

Infections Complicating Pulsed Carbon Dioxide Laser Resurfacing for Photoaged Facial Skin

background With proper technique and instrumentation, laser resurfacing for facial wrinkles has been found to be highly effective and relatively safe. Most, if not all, of the noninfectious complications such as pigmentary changes, scarring, and persistent erythema can either be avoided or managed with appropriate therapy. Postoperative injections, on the other hand, may develop despite proper technique and instrumentation. Without proper management, they may cause significant physical morbidity and psychological distress defying the expected benefit of the procedure. objective To quantify the incidence and to study the characteristics of infections arising after laser resurfacing for facial wrinkles with pulsed carbon dioxide laser treatment. METHOD. A retrospective study was carried out by reviewing the records of all patients undergoing laser resurfacing for facial wrinkles from January 1, 1995 to April 30, 3996. An infection is defined as a positive culture in the presence of signs or symptoms of an infection. results Over 16 months, 395 procedures were performed and 17 cases of. culture‐proven infection recorded, an incidence of 4.3%. All patients had symptoms starting between days 2 and 10 after the operation. Over half of the patients had multiple infections with two to three microorganisms. Pseudomonas aeruginosa was the most common causative agent, found in 41 % of all infected cases, followed by Staphylococcus aureus (35%), S. epidermidis (35%), and Candida species (24%). Multiple drug‐resistant, gram‐negative bacteria were found in four cases, implicating the possibility of hospital‐acquired infections. Almost all isolates of gram‐positive bacteria were resistant to both erythromycin and penicillin, but not oxacillin. With proper treatment, most patients healed normally. Only one patient had persistent, multiple atrophic scars due to locally disseminated herpes simplex infection despite proper prophylaxis and treatment. conclusions Postoperative infection is uncommon and manageable with early recognition and proper treatment. The types of infectious agents being found are very similar to those reported in burn patients. This complication has been found to be much more common in patients undergoing full face resurfacing and those using a bio‐occlusive dressing postoperatively. With comprehensive preventive and management measures, it is likely that this type of uncommon, yet distressful, complication can be avoided and more successfully treated. Recommendations are made for prevention and management of suspected postoperative infections.

Twelve-month persistency of a novel ribose-cross-linked collagen dermal filler.

BACKGROUND The porcine collagen–derived dermal filler Dermicol-P35 (Evolence, Colbar LifeScience Ltd, Herzliya, Israel) has low immunogenicity and the potential to provide a long-lasting corrective response for soft-tissue contour deficiencies and deformities. OBJECTIVE The objective was to assess the persistence of the corrective response with Dermicol-P35 up to 12 months after obtaining an optimal cosmetic result (OCR) in a randomized, multicenter study comparing the efficacy and safety of Dermicol-P35 with the hyaluronic acid (HA) filler Restylane (Medicis Pharmaceutical Co.). METHODS & MATERIALS Subjects with moderate to deep nasolabial wrinkles (n=149) were randomized to injections of either Dermicol-P35 or HA on one side of the face and the alternative preparation on the contralateral side. If necessary, one touch-up injection could be given after 2 weeks to obtain an OCR. RESULTS Although the mean Modified Fitzpatrick Wrinkle Scale score increased gradually after achieving the OCR with Dermicol-P35, 95.3 and 76.5% of subjects, respectively, met the criteria for persistence of the corrective response after 9 and 12 months. Persistency rates were similar regardless of the requirement for a touch-up injection at Week 2. No unexpected, severe, or serious injection-related adverse events were experienced. CONCLUSION The effectiveness of Dermicol-P35 appears to be maintained for up to 1 year after achieving an OCR, both for touch-up and for non–touch-up subjects.

A Randomized, Blinded Clinical Evaluation of a Novel Microwave Device for Treating Axillary Hyperhidrosis: The Dermatologic Reduction in Underarm Perspiration Study

BACKGROUND Duration of effect and effectiveness limit current options for treating axillary hyperhidrosis. A new microwave procedure for treatment of axillary hyperhidrosis has been tested. STUDY DESIGN/MATERIALS AND METHODS Adults with primary axillary hyperhidrosis were enrolled in a randomized, sham‐controlled, blinded study. Subjects were required to have a Hyperhidrosis Disease Severity Scale (HDSS) score of 3 or 4 and baseline sweat production greater than 50 mg/5 min. Procedures were administered using a proprietary microwave energy device that isolates and heats target tissue. Responders were defined as subjects reporting a HDSS score of 1 or 2. Subjects were followed for 6 months (sham group) or 12 months (active group). RESULTS Thirty days after treatment, the active group had a responder rate of 89% (72/81), and the sham group had a responder rate of 54% (21/39) (P < .001). Treatment efficacy was stable from 3 months (74%) to 12 months (69%), when follow‐up ended. Adverse events were generally mild, and all but one resolved over time. CONCLUSIONS The procedure demonstrated statistically significant, long‐term efficacy in sweat reduction. As with any new procedure, findings from this first investigational device study identified optimization strategies for the future.

Tumescent Anesthesia in Ambulatory Phlebectomy

background. Ambulatory phlebectomy is an elegant outpatient procedure for the removal of varicose veins. One of the keys to its success is the ability to perform the procedure under local anesthesia. A new form of anesthesia, tumescent anesthesia, has been developed for liposuction surgery and is now being expanded for use in other surgical disciplines. objective. To determine the efficacy and safety as well as review the use and advantages of tumescent anesthesia in ambulatory phlebectomy. methods. A retrospective review of phlebectomy cases performed in our offices under tumescent anesthesia. results. The reported level of intraoperative and postoperative pain was very low. The complication rate was consistent with other reports except for a higher number of hematomas (3.4%). conclusions. Tumescent anesthesia provides a very safe, comfortable method of anesthetizing patients for ambulatory phlebectomy. Epinephrine, in appropriate concentrations, should be a part of all tumescent anesthetic solutions used for phlebectomy as it may decrease the incidence of hematoma.

Effectiveness of Juvéderm Ultra Plus dermal filler in the treatment of severe nasolabial folds.

Background: With the baby boomer generation firmly ensconced in middle age and the ubiquity of botulinum toxin type A, nonsurgical facial rejuvenation is becoming increasingly prevalent. As this generation continues to age, products with greater therapeutic power to correct aging changes will be in growing demand. Methods: A multicenter, double-blind, randomized, within-subject, controlled study was conducted comparing Juvéderm Ultra Plus hyaluronic acid filler with bovine collagen. A subset of subjects classified as having treatment for severe nasolabial folds is presented in this article. Subjects received Juvéderm Ultra Plus in one severe nasolabial fold and Zyplast collagen in the other nasolabial fold; up to two touch-up treatments were allowed at 2-week intervals. Nasolabial fold severity was evaluated every 4 weeks for 24 weeks using a five-point scale. Treatment site reactions and adverse events were also recorded. A complimentary treatment was offered at the end of the trial, with effectiveness evaluations just before retreatment and up to 48 weeks after repeated treatment for a subset of subjects. Results: Of the 87 subjects, most were female Caucasians, but all Fitzpatrick skin types were represented (36 percent types IV through VI). At 24 weeks, 96 percent of nasolabial folds treated with Juvéderm had maintained clinically significant correction, and 81 percent maintained the correction for 1 year or more. Results were similar for those subjects with follow-up through 48 weeks after repeated treatment. The median volume required for repeated treatment with Juvéderm was significantly less than that for initial treatment (0.7 ml versus 1.6 ml). Conclusion: Juvéderm Ultra Plus provides correction of severe nasolabial folds through 1 year or more.

Eyelash growth in subjects treated with bimatoprost: A multicenter, randomized, double-masked, vehicle-controlled, parallel-group study

BACKGROUND Bimatoprost 0.03% is associated with increased growth and prominence of eyelashes. OBJECTIVE We sought to compare the safety and efficacy of once-daily bimatoprost 0.03% versus vehicle in increasing eyelash length, thickness, and darkness after topical administration to upper eyelid margins. METHODS In this 5-month study, subjects were randomized to receive once-daily bimatoprost 0.03% (n = 137) or vehicle (n = 141). The primary end point was eyelash prominence assessed by the investigator global eyelash assessment scale. Secondary efficacy measures included eyelash length, thickness, and darkness measured by digital image analysis and patient-reported outcomes. Safety data included adverse event monitoring and ophthalmic examinations. RESULTS A higher percentage of subjects treated with bimatoprost 0.03% (78.1%) versus vehicle (18.4%) demonstrated at least a 1-grade increase in global eyelash assessment score at week 16 (P < .0001). Subjects in the bimatoprost 0.03% group also had statistically significantly greater increases in eyelash length, thickness, and darkness (P < .0001) than those in the vehicle group. For adverse events, only conjunctival hyperemia occurred at a statistically significant higher incidence rate in the bimatoprost 0.03% versus the vehicle group (P = .03). LIMITATIONS Short-term duration of the trial was a limitation; black subjects were not enrolled secondary to technical requirements of digital image analysis. CONCLUSION Bimatoprost 0.03% was found to be effective at enhancing eyelashes in adults with a very good safety profile.

Successful Treatment of Depressed, Distensible Acne Scars Using Autologous Fibroblasts: A Multi-Site, Prospective, Double Blind, Placebo-Controlled Clinical Trial

Background A previous clinical trial evaluating autologous fibroblasts (human dermal) injections for the treatment of facial contour deformities found significantly greater improvements in wrinkle and acne scar appearance than with placebo treatment. Objective To compare the efficacy and safety of autologous fibroblast treatment of moderate to severe, depressed, distensible facial acne scars with that of vehicle control. Methods This was a randomized multicenter, double‐blind, placebo‐controlled trial in subjects with bilateral moderate to severe acne scarring; subjects served as their own controls. Skin biopsies were obtained from randomized subjects for fibroblast production. Subjects (n = 99) underwent three intradermal injection sessions with 2 mL of autologous fibroblast suspension (10–20 million cells/mL) on one cheek and vehicle control (cell culture medium) on the other at 14‐day intervals. Efficacy was based on the blinded subjects, evaluators, and independent photographic viewers (IPR) assessment of acne scarring 1 to 4 months after the last treatment. Results Autologous fibroblast treatment was associated with significantly greater treatment success than vehicle control for the subject (43% vs 18%), evaluator (59% vs 42%), and IPR assessments. Autologous fibroblast injections were well tolerated, without permanent adverse effects. Conclusions Autologous fibroblast injections safely and effectively improved the appearance of depressed distensible acne scars.

Understanding the Functional Anatomy of the Frontalis and Glabellar Complex for Optimal Aesthetic Botulinum Toxin Type A Therapy

BackgroundBotulinum neurotoxin type A (BoNTA) is approved for the treatment of glabellar lines and also is commonly injected in an off-label fashion in the frontalis (i.e., frontalis epicranius) muscle to improve the appearance of horizontal forehead lines. This study aimed to review and discuss both the anatomy and physiology of the frontalis muscle and its relationship with antagonist muscles in the upper face and to provide a guide for the use of BoNTA to treat forehead rhytides while minimizing the occurrence of complications such as brow ptosis.MethodsA PubMed search was conducted to identify practitioner opinion and clinical publications on the efficacy and safety of BoNTA for aesthetic treatment of the upper face.ResultsThe use of BoNTA produces durable improvement in the appearance of moderate to severe horizontal forehead lines. Dose and injection technique must be adjusted and individualized based on the variable anatomy and function/mass of muscles in the forehead and upper face as well as on patient goals. Optimal aesthetic outcomes can be achieved by skillfully balancing the opposing effects of the frontalis muscle and its intricate interactions with the procerus, corrugator supercilii, depressor supercilii, and orbicularis oculi muscles.ConclusionsThe use of BoNTA to improve the aesthetic appearance of horizontal forehead lines is optimized when clinicians take into account variations in frontalis muscle function and position, anatomy of the brow, and proper injection technique when they devise individualized treatment regimens.Level of Evidence VThis journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

A multicenter, double-blind, placebo-controlled trial of autologous fibroblast therapy for the treatment of nasolabial fold wrinkles.

BACKGROUND Changes associated with aging are partly due to loss of collagen and elastin. Treatment with autologous fibroblasts grown in culture (azficel‐T) can help correct the appearance of aging by replacing lost dermal constituents. OBJECTIVE To demonstrate the safety and effectiveness of autologous fibroblasts in the treatment of nasolabial fold (NLF) wrinkles. METHODS AND MATERIALS Adults with moderate to very severe NLF wrinkles were randomized to receive three treatments with autologous fibroblasts or placebo at 5‐week intervals. Blinded evaluators and subjects assessed efficacy using a validated wrinkle assessment scale. RESULTS Three hundred seventy‐two subjects were enrolled and underwent treatment. Seventy‐eight percent of subjects treated with autologous fibroblast therapy and 48% of subjects treated with placebo achieved at least a 1‐point improvement on the subject assessment at 6 months (p < 0.001), and 64% of subjects treated with autologous fibroblast therapy and 36% of those treated with placebo showed at least a 1–point improvement evaluators assessment (p < 0.001). Adverse events were generally mild, and the treatment was well tolerated. CONCLUSION Autologous fibroblast therapy is safe and effective for the treatment of NLF wrinkles. The availability of autologous cell therapy marks the beginning of a new phase in aesthetic therapy.

A Comparison of Commercially Available Polymethylmethacrylate‐Based Soft Tissue Fillers

BACKGROUND The rapid market expansion of filler treatment options requires physicians and health care providers to fully understand differences among comparable products. OBJECTIVE The objective was to compare commercially available polymethylmethacrylate (PMMA)-based soft tissue fillers to determine if there are meaningful variations in these products that could result in significantly different therapeutic profiles, especially with respect to safety. METHODS AND MATERIALS PMMA particles were evaluated for size and morphology using scanning electron microscopy (SEM) techniques. PMMA microsphere soft tissue filler products from the United States, Europe, Brazil, and Canada were compared with respect to size, homogeneity/irregularity, surface smoothness/roughness, and the presence or absence of sediment and particulate debris. RESULTS Marked differences with respect to PMMA particle morphology and related particle characteristics from a variety of products were found. Of note, some products demonstrated potentially concerning significant variability in particle size and irregular morphology. CONCLUSION It is anticipated that the variability detected in these products, based on the literature, could result in different therapeutic profiles, especially with respect to safety. Physicians and health care providers should be aware that “comparable” products that at a glance appear similar may not be equal.