Kenneth Beer

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.

A randomized, evaluator-blinded, controlled study of effectiveness and safety of small particle hyaluronic acid plus lidocaine for lip augmentation and perioral rhytides.

OBJECTIVE To compare the safety and effectiveness of small particle hyaluronic acid plus lidocaine (SPHAL) versus no treatment for lip augmentation and perioral rhytides. METHODS AND MATERIALS Adults scoring 1 (very thin) to 2 (thin) on the Medicis Lip Fullness Scale (MLFS) for upper and lower lips were randomized (3:1) to SPHAL or no treatment. Treatment success was an MLFS increase ≥1 point at Week 8. Secondary end points (MLFS score, independent photographic review, Global Aesthetic Improvement Scale, Wrinkle Assessment Scale for Upper Lip Lines) and safety were assessed throughout. RESULTS Statistically significantly more patients were treatment successes with SPHAL (upper lip [80.2% vs 11.9%], lower lip [84.2% vs 18.4%], and upper and lower lips combined [76.1% vs 11.6%]), compared with no treatment (p <.001, all outcomes). Patients treated for both lip augmentation and perioral rhytides were rated as having an aesthetically meaningful improvement in perioral rhytides (p <.001). Most common treatment-emergent adverse events (AEs) included lip bruising, swelling, and pain and were mostly mild and transient in nature, without anticipated device AEs. CONCLUSION Small particle hyaluronic acid plus lidocaine was effective and well tolerated and significantly more effective when both lips and perioral rhytides were treated, with improvement evident up to 6 months after treatment.

Bimatoprost 0.03% for the Treatment of Eyebrow Hypotrichosis

BACKGROUND Eyebrow loss may have substantial negative functional and social consequences. OBJECTIVE Evaluate the safety and efficacy of bimatoprost 0.03% in subjects with eyebrow hypotrichosis. METHODS This multicenter, double-masked study randomized adult females or males with eyebrow hypotrichosis to receive bimatoprost 0.03% twice (BID) or once daily (QD) or vehicle BID for 7 months. Primary endpoint was overall eyebrow fullness at Month 7. Secondary endpoints included eyebrow fullness (mm2), darkness (intensity units), and subject satisfaction with treatment. Safety was also assessed. RESULTS At Month 7, the proportion of subjects with improvement was significantly higher in bimatoprost groups versus vehicle (both, p < .001). Improvements occurred in both bimatoprost groups versus vehicle after Month 1 and continued through follow-up; eyebrow fullness and darkness improved as early as Months 2 and 1, respectively (both, p < .001). Greater satisfaction was reported with bimatoprost versus vehicle at Month 2 and all subsequent time points. Overall, 38.1%, 42.4%, and 35.5% of subjects in the bimatoprost BID, QD, and vehicle groups, respectively, experienced ≥1 treatment-emergent adverse event (TEAE). Most frequent TEAEs were similar across groups. No skin or iris hyperpigmentation or conjunctival hyperemia occurred. CONCLUSION Bimatoprost 0.03% BID and QD is safe, well tolerated, and effective for eyebrow hypotrichosis.

Efficacy and Safety of ATX-101 by Treatment Session: Pooled Analysis of Data From the Phase 3 REFINE Trials

Abstract Background ATX-101 (deoxycholic acid injection) is the only injectable drug approved for submental fat (SMF) reduction. In the phase 3 REFINE trials, adults with moderate or severe SMF who were dissatisfied with the appearance of their face/chin were eligible to receive up to 6 treatment sessions with ATX-101 (2 mg/cm2) or placebo. Primary and secondary endpoints, evaluated at 12 weeks after last treatment, significantly favored ATX-101 supporting its efficacy for reducing SMF and the psychological impact of SMF, and increasing satisfaction with the appearance of the face/chin. Objectives To evaluate the efficacy and safety of ATX-101 by treatment session. Methods This post hoc analysis used pooled data from the REFINE trials to evaluate efficacy endpoints and adverse events following each treatment session to further characterize the ATX-101 treatment response and safety profile. Results In both treatment groups, mean injection volume declined over subsequent treatment sessions, though more markedly in the ATX-101 group. The majority of ATX-101–treated patients achieved a ≥1-grade improvement in SMF within 2 to 4 treatment sessions based on either clinician or patient assessment. Furthermore, 19.1% of ATX-101–treated patients (vs 3.9% of placebo-treated patients) received fewer than 6 treatment sessions owing to patient satisfaction with treatment or lack of sufficient SMF for further treatment. In both treatment groups, the incidence/severity of common injection-site adverse events declined over subsequent treatment sessions. Conclusions Although up to 6 treatment sessions were permitted in the REFINE trials, most ATX-101–treated patients achieved an improvement in SMF within 2 to 4 treatment sessions. Level of Evidence: 3

Inflammatory Features of Frontal Fibrosing Alopecia

Frontal fibrosing alopecia (FFA) is a cicatricial alopecia typically occurring in postmenopausal women. The etiology and pathophysiology of FFA is poorly understood but thought to be immune mediated. This study aims to further explore the extent of fibrosis and the inflammatory microenvironment by characterizing Langerhans cells (LCs), helper T cells, cytotoxic T cells and B cells near hair follicles in FFA.

Volumizing Hyaluronic Acid Filler for Midface Volume Deficit: Results After Repeat Treatment.

BACKGROUND Juvéderm Voluma XC (VYC-20L; hyaluronic acid gel) is approved in the United States for correction of age-related midface volume deficit (MVD). OBJECTIVE Assess safety and effectiveness of VYC-20L after repeat treatment. METHODS Subjects with MVD underwent optional repeat treatment 12 to 24 months after initial treatment if correction was lost or at 24 months regardless of loss of correction (n = 167). Investigators rated outcomes on the Mid-Face Volume Deficit Scale (MFVDS) and the Global Aesthetic Improvement Scale (GAIS). Subject-rated outcomes were the GAIS, overall satisfaction with facial appearance, achievement of treatment goal, and Self-Perception of Age questionnaire. Subjects recorded treatment-site responses in 30-day diaries. RESULTS Mean injection volume for repeat treatment (3.13 mL) was approximately half the mean total injection volume for initial/touch-up treatment (6.8 mL). After repeat treatment, effectiveness was demonstrated on all investigator-rated and subject-rated measures, consistent with results observed after initial treatment. The percentage of subjects improving by ≥1 point on the MFVDS was 82.8% and 91.1% at 6 and 12 months after repeat treatment, respectively. The incidence, severity, and duration of common treatment-site responses were lower after repeat versus initial treatment. CONCLUSION Repeat treatment with VYC-20L was well tolerated and resulted in high levels of effectiveness and subject satisfaction.

Commentary on Skin Remodeling Using Hyaluronic Acid Filler Injections in Photo-Aged Faces.

It is often said that a picture is worth a thousand words. In this instance, it is likely that this is an understatement. This well-designed trial provides pictures of the changes afforded by injections with hyaluronic acids and descriptions of these changes that are clear and concise. With approximately 1.7 million injections of hyaluronic acid last year, the data that the authors provide to fellow physicians, patients, and regulatory bodies have enormous implications. This study is awelcome addition to the previous literature about duration of hyaluronic implants and collagen stimulation as a result of these implants. These authors designed and conducted a brilliant study that demonstrates in a clear and convincing manner how hyaluronic acids interact with the dermis over time. In their study, 20 patients were injected with hyaluronic acid and biopsies were taken at baseline, at 3 and at 9 months. Among the findings that they discovered are the facts that hyaluronic acid persists to a degree i.e., longer than many surmised. In addition, although previous authors have demonstrated collagen stimulation, these authors demonstrate that the collagen, elastic, and epidermal cells look better and more organized after injections of hyaluronic acid. Moreover, they quantified the data and used reproducible measures by which their study may be extended. According to morphometric analysis performed by the authors, collagen fibers increased by 34% and 39% at 3 and 9 months after the injections, respectively. They document a decrease in elastic fibers at 3 months but an increase at 9. In addition, they demonstrate persistence of the gel at 9 months. In addition, they suggest that mechanical stimulation is likely to be the most important determinant of collagen product, and they cite earlier work as support.