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.

An expert panel consensus on opioid-prescribing guidelines for dermatologic procedures.

BACKGROUND: Opioid overprescribing is a major contributor to the opioid crisis. The lack of procedure-specific guidelines contributes to the vast differences in prescribing practices. OBJECTIVE: To create opioid-prescribing consensus guidelines for common dermatologic procedures. METHODS: We used a 4-step modified Delphi method to conduct a systematic discussion among a panel of dermatologists in the fields of general dermatology, dermatologic surgery, and cosmetics/phlebology to develop opioid prescribing guidelines for some of the most common dermatologic procedural scenarios. Guidelines were developed for opioid-naive patients undergoing routine procedures. Opioid tablets were defined as oxycodone 5-mg oral equivalents. RESULTS: Postoperative pain after most uncomplicated procedures (76%) can be adequately managed with acetaminophen and/or ibuprofen. Group consensus identified no specific dermatologic scenario that routinely requires more than 15 oxycodone 5-mg oral equivalents to manage postoperative pain. Group consensus found that 23% of the procedural scenarios routinely require 1 to 10 opioid tablets, and only 1 routinely requires 1 to 15 opioid tablets. LIMITATIONS: These recommendations are based on expert consensus in lieu of quality evidence-based outcomes research. These recommendations must be individualized to accommodate patients' comorbidities. CONCLUSIONS: Procedure-specific opioid prescribing guidelines may serve as a foundation to produce effective and responsible postoperative pain management strategies after dermatologic interventions.

Quantitative comparison of topical aluminum salt solution efficacy for management of sweating: a randomized, controlled trial.

BACKGROUND: There is a lack of studies objectively comparing the efficacy of topical antiperspirants in reducing sweat. OBJECTIVE: To objectively and quantitatively compare the efficacy of two aluminum salt solutions for the reduction of induced sweating. METHODS: A subject, rater, and statistician-blinded, randomized, controlled trial. Nineteen subjects were exposed to a standardized heat challenge for 3 h. Topical agent A (20% aluminum chloride hexahydrate) was randomized to either axilla, and topical agent B (1% aluminum acetate) assigned to the contralateral side. A sauna suit induced sweating during three 30-min heat intervals: (1) with no study agents (pre); (2) with both study agents, one on each side; and (3) after the agents were washed off (post). Sweat levels were measured by securing Whatman(®) filter paper to each axilla and measuring the paper weight after each heat interval. The difference in paper weight following each heat interval between Study Agent A and Study Agent B was measured by a gravimetric scale. RESULTS: Topical agent A had a significantly greater effect at reducing axillary sweating than B (P = 0.0002). CONCLUSION: In a sweating simulation, 20% aluminum chloride hexahydrate quantitatively and objectively appeared to reduce sweat more effectively than 1% aluminum acetate.

Treatment of keratosis pilaris with 810-nm diode laser: a randomized clinical trial.

IMPORTANCE: Keratosis pilaris (KP) is a common skin disorder of follicular prominence and erythema that typically affects the proximal extremities, can be disfiguring, and is often resistant to treatment. Shorter-wavelength vascular lasers have been used to reduce the associated erythema but not the textural irregularity. OBJECTIVE: To determine whether the longer-wavelength 810-nm diode laser may be effective for treatment of KP, particularly the associated skin roughness/bumpiness and textural irregularity. DESIGN, SETTING, AND PARTICIPANTS: We performed a split-body, rater-blinded, parallel-group, balanced (1:1), placebo-controlled randomized clinical trial at a dermatology outpatient practice of an urban academic medical center from March 1 to October 1, 2011. We included all patients diagnosed as having KP on both arms and Fitzpatrick skin types I through III. Of the 26 patients who underwent screening, 23 met our enrollment criteria. Of these, 18 patients completed the study, 3 were lost to or unavailable for follow-up, and 2 withdrew owing to inflammatory hyperpigmentation after the laser treatment. INTERVENTIONS: Patients were randomized to receive laser treatment on the right or left arm. Each patient received treatment with the 810-nm pulsed diode laser to the arm randomized to be the treatment site. Treatments were repeated twice, for a total of 3 treatment visits spaced 4 to 5 weeks apart. MAIN OUTCOMES AND MEASURES: The primary outcome measure was the difference in disease severity score, including redness and roughness/bumpiness, with each graded on a scale of 0 (least severe) to 3 (most severe), between the treated and control sites. Two blinded dermatologists rated the sites at 12 weeks after the initial visit. RESULTS: At follow-up, the median redness score reported by the 2 blinded raters for the treatment and control sides was 2.0 (interquartile range [IQR], 1-2; P = .11). The median roughness/bumpiness score was 1.0 (IQR, 1-2) for the treatment sides and 2.0 (IQR, 1-2) for the control sides, a difference of 1 (P = .004). The median overall score combining erythema and roughness/bumpiness was 3.0 (IQR, 2-4) for the treatment sides and 4.0 (IQR, 3-5) for the control sides, a difference of 1 (P = .005). CONCLUSIONS AND RELEVANCE: Three treatments with the 810-nm diode laser may induce significant improvements in skin texture and roughness/bumpiness in KP patients with Fitzpatrick skin types I through III, but baseline erythema is not improved. Complete treatment of erythema and texture in KP may require diode laser treatment combined with other laser or medical modalities that address redness. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01281644.

Multicenter prospective cohort study of the incidence of adverse events associated with cosmetic dermatologic procedures: lasers, energy devices, and injectable neurotoxins and fillers.

IMPORTANCE: Common noninvasive to minimally invasive cosmetic dermatologic procedures are widely believed to be safe given the low incidence of reported adverse events, but reliable incidence data regarding adverse event rates are unavailable to date. OBJECTIVE: To assess the incidence of adverse events associated with noninvasive to minimally invasive cosmetic dermatologic procedures, including those involving laser and energy devices, as well as injectable neurotoxins and fillers. DESIGN, SETTING, AND PARTICIPANTS: A multicenter prospective cohort study (March 28, 2011, to December 30, 2011) of procedures performed using laser and energy devices, as well as injectable neurotoxins and soft-tissue augmentation materials, among 8 geographically dispersed US private and institutional dermatology outpatient clinical practices focused on cosmetic dermatology, with a total of 23 dermatologists. Participants represented a consecutive sample of 20 399 cosmetic procedures. Data acquisition was for 3 months (13 weeks) per center, with staggered start dates to account for seasonal variation. EXPOSURES: Web-based data collection daily at each center to record relevant procedures, by category type and subtype. Adverse events were detected by (1) initial observation by participating physicians or staff; (2) active ascertainment from patients, who were encouraged to self-report after their procedure; and (3) follow-up postprocedural phone calls to patients by staff, if appropriate. When adverse events were not observed by physicians but were suspected, follow-up visits were scheduled within 24 hours to characterize these events. Detailed information regarding each adverse event was entered into an online form. MAIN OUTCOMES AND MEASURES: The main outcome was the total incidence of procedure-related adverse events (total adverse events divided by total procedures performed), as verified by clinical examination. RESULTS: Forty-eight adverse events were reported, for a rate of 0.24% (95% CI, 0.18%-0.31%). Overall, 36 procedures resulted in at least 1 adverse event, for a rate of 0.18% (95% CI, 0.13%-0.25%). No serious adverse events were reported. Adverse events were infrequently associated with known risk factors. CONCLUSIONS AND RELEVANCE: Noninvasive to minimally invasive cosmetic dermatologic procedures, including energy, neurotoxin, and filler procedures, are safe when performed by experienced board-certified dermatologists. Adverse events occur in less than 1% of patients, and most of these are minor and transient.

Efficacy of a needling device for the treatment of acne scars: a randomized clinical trial.

IMPORTANCE: Neocollagenesis can be achieved using a dermal rolling needle device, thereby reducing the appearance of acne scars. OBJECTIVE: To determine the efficacy of a needling device for treatment of acne scars. DESIGN, SETTING, AND PARTICIPANTS: We performed a single-center, rater-blinded, balanced (1:1), split-face, placebo-controlled, parallel-group randomized clinical trial at an urban academic institution. The study took place from November 30, 2009, through July 27, 2010. Twenty healthy adults (age range, 20-65 years) with acne scars on both sides of the face were enrolled. Fifteen individuals completed the study, and no enrolled participants were withdrawn for adverse effects. INTERVENTIONS: For each participant, one side of the face was randomized for needling. Three needling treatments were performed at 2-week intervals. MAIN OUTCOMES AND MEASURES: Two blinded dermatologists separately rated participants' acne scars based on standard digital photographs obtained at baseline and at the 3-month and 6-month follow-up visits on the quantitative global scarring grading system. RESULTS: Mean scar scores were significantly lower in the treatment group compared with baseline at 6 months (mean difference, 3.4; 95% CI, 0.2-6.5; P = .03) and nominally but not significantly lower compared with baseline at 3 months (mean difference, 2.4; 95% CI, -0.01 to 4.8; P = .052). In the control group, mean scar scores did not vary significantly from baseline at 3 months (mean difference, 1.0; 95% CI, -1.4 to 3.4; P = .96) and at 6 months (mean difference, 0.4; 95% CI, -2.3 to 3.5; P > .99). The needling procedure was not particularly painful, with a mean pain rating of 1.08 of 10. Participants perceived a 41% mean improvement in overall scar appearance on the treated side. No adverse events were reported. CONCLUSIONS AND RELEVANCE: After 3 needling treatments, there was improvement in the appearance of acne scars over time compared with the control group, with minimal pain reported. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00974870.

Pain in naïve and non-naïve subjects undergoing nonablative skin tightening dermatologic procedures: a nested randomized control trial.

BACKGROUND: Pain is expected during noninvasive skin tightening and can be anxiety provoking, especially for those who have not had prior treatments. OBJECTIVE: To compare pain reported by patients naïve to nonablative skin tightening energy devices with those who were not naive. METHODS AND MATERIALS: The non-naïve group at least three nonablative laser procedures or one nonablative skin tightening procedure, and the naïve group no previous treatments. Four sites at each of two anatomic locations (periorbital and midface or cheek) were treated in each subject with needle prick, pulsed dye laser, radiofrequency, and ultrasound with the order of the interventions randomized. All interventions except ultrasound were also applied to three abdominal sites. The difference in mean pain scores between naïve and nonnaïve subjects were averaged over the anatomic sites. RESULTS: Ten naïve and 10 non-naïve subjects completed study procedures. Mean pain scores ranged from 1.3 to 4.9. The mean for all naïve conditions was 2.3 ± 1.0, vs 2.2 ± 1.4 for non-naïve conditions. There was no overall difference according to group, device, or anatomic area. CONCLUSIONS: There was no significant difference in pain between naïve and non-naïve subjects undergoing cutaneous energy treatments. Individual devices may elicit more pain at specific anatomic locations.

Multiple linear leiomyomas of the forehead as the presenting sign of Reed syndrome.

A 62-year-old female presented with a linear arrangement of multiple asymptomatic, discrete, dome-shaped, smooth, skin-colored papules and nodules involving the left forehead. Histopathology showed a poorly circumscribed nodule of haphazardly arranged fascicles of smooth muscle cells involving the papillary and superficial reticular dermis. Genetic testing revealed the patient to be heterozygous for the R233H mutation in the fumarate hydratase gene. Clinical, microscopic, and genetic findings were consistent with a diagnosis of Reed syndrome. Reed syndrome is a rare disorder defined by cutaneous and uterine leiomyomas and, uncommonly, renal cell carcinoma.

Linear IgA bullous disease presenting as toxic epidermal necrolysis: a case report and review of the literature.

A 91-year-old female presented with widespread skin sloughing and bullae clinically mimicking toxic epidermal necrolysis (TEN). The patient was on multiple antibiotics, including vancomycin and piperacillin/tazobactam. Histopathology and direct immunofluorescence were consistent with a diagnosis of linear IgA bullous disease (LABD). In a PubMed review of the literature from 1975 to the present, there have been 15 cases of LABD presenting as TEN clinically and with characteristic linear IgA deposits on direct immunofluorescence studies. Vancomycin and phenytoin were the most commonly implicated medications. Twelve patients saw a resolution or healing of skin lesions after discontinuation of the implicated medication. There were, however, 5 patients who died of complications related to their comorbidities. It is important to include LABD in the differential diagnosis when evaluating patients who clinically present with TEN.

Adverse events associated with mohs micrographic surgery: multicenter prospective cohort study of 20,821 cases at 23 centers.

IMPORTANCE: Detailed information regarding perioperative risk and adverse events associated with Mohs micrographic surgery (MMS) can guide clinical management. Much of the data regarding complications of MMS are anecdotal or report findings from single centers or single events. OBJECTIVES: To quantify adverse events associated with MMS and detect differences relevant to safety. DESIGN, SETTING, AND PARTICIPANTS: Multicenter prospective inception cohort study of 21 private and 2 institutional US ambulatory referral centers for MMS. Participants were a consecutive sample of patients presenting with MMS for 35 weeks at each center, with staggered start times. EXPOSURE: Mohs micrographic surgery. MAIN OUTCOMES AND MEASURES Intraoperative and postoperative minor and serious adverse events. RESULTS: Among 20 821 MMS procedures, 149 adverse events (0.72%), including 4 serious events (0.02%), and no deaths were reported. Common adverse events reported were infections (61.1%), dehiscence and partial or full necrosis (20.1%), and bleeding and hematoma (15.4%). Most bleeding and wound-healing complications occurred in patients receiving anticoagulation therapy. Use of some antiseptics and antibiotics and sterile gloves during MMS were associated with modest reduction of risk for adverse events. CONCLUSIONS AND RELEVANCE: Mohs micrographic surgery is safe, with a very low rate of adverse events, an exceedingly low rate of serious adverse events, and an undetectable mortality rate. Common complications include infections, followed by impaired wound healing and bleeding. Bleeding and wound-healing issues are often associated with preexisting anticoagulation therapy, which is nonetheless managed safely during MMS. We are not certain whether the small effects seen with the use of sterile gloves and antiseptics and antibiotics are clinically significant and whether wide-scale practice changes would be cost-effective given the small risk reductions.

The comparative effectiveness of suction-curettage and onabotulinumtoxin-A injections for the treatment of primary focal axillary hyperhidrosis: a randomized control trial.

BACKGROUND: Botulinum toxin injections and suction-curettage have been separately shown to be effective in treating axillary hyperhidrosis but have not been compared in the same patients. OBJECTIVE: We sought to compare effectiveness of suction-curettage versus neurotoxin for the treatment of axillary hyperhidrosis. METHODS: Each of 20 patients was randomized to receive toxin injections to one axilla and suction-curettage to the contralateral axilla. The primary outcome measure was reduction of sweat rate measured by gravimetry, and the secondary measure was quality of life as measured by a patient-directed questionnaire. RESULTS: At 3 months posttreatment, toxin injections decreased baseline resting sweat production by 72.1% versus 60.4% (P = .29) for suction-curettage, and baseline exercise-induced sweat production by 73.8% versus 58.8% (P = .10). When patients were stratified into the categories of light and heavy sweaters, there was a difference among heavy sweaters, with exercise-induced sweat production lower by 10.48 mg/min or 34.3% (P = .0025) at toxin-treated sites. Compared with suction-curettage, toxin also resulted in greater improvements in quality of life by 0.80 points (P = .0002) and 0.90 points (P = .0017) at 3 and 6 months posttreatment, respectively, as measured by the patient questionnaire. LIMITATIONS: The follow-up period was limited to 6 months. CONCLUSIONS: By objective measures 3 months after treatment, neurotoxin injections are nominally more effective than suction-curettage in all cases, and markedly more effective in heavy sweaters. Patients have a very significant preference for neurotoxin injections at 3 months, and this is maintained at 6 months.

Association between type of reconstruction after Mohs micrographic surgery and surgeon-, patient-, and tumor-specific features: a cross-sectional study.

BACKGROUND: There are few data to indicate whether the type of final wound defect is associated with the type of post-Mohs repair. OBJECTIVE: To determine the methods of reconstruction that Mohs surgeons typically select and, secondarily, to assess the association between the method and the number of stages, tumor type, anatomic location, and patient and surgeon characteristics. METHODS: Statistical analysis of procedure logs of 20 representative young to mid-career Mohs surgeons. RESULTS: The number of stages associated with various repairs were different (analysis of variance, p < .001.). Linear repairs, associated with the fewest stages (1.5), were used most commonly (43-55% of defects). Primary repairs were used for 20.2% to 35.3% of defects of the nose, eyelids, ears, and lips. Local flaps were performed typically after two stages of Mohs surgery (range 1.98-2.06). Referral for repair and skin grafts were associated with cases with more stages (2.16 and 2.17 stages, respectively). Experienced surgeons were nominally more likely perform flaps than grafts. Regression analyses did not indicate any association between patient sex and closure type (p = .99) or practice location and closure type (p = .99). CONCLUSIONS: Most post-Mohs closures are linear repairs, with more bilayered linear repairs more likely at certain anatomic sites and after a larger number of stages.