Σφακιανάκης Αλέξανδρος
ΩτοΡινοΛαρυγγολόγος
Αναπαύσεως 5 Άγιος Νικόλαος
Κρήτη 72100
00302841026182
00306932607174
alsfakia@gmail.com

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Κυριακή 11 Απριλίου 2021

Prior Botulinum Toxin Treatment Does Not Impact Efficacy or Safety in Clinical Trials: Analysis of DaxibotulinumtoxinA for Injection in the SAKURA Program

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imageBACKGROUND Pivotal studies of approved botulinum toxin type A (BoNTA) formulations for treatment of glabellar lines have mostly included treatment-naive participants, and the impact of prior BoNTA treatment on efficacy and safety is not well documented. OBJECTIVE To evaluate whether prior BoNTA treatment affects efficacy, duration of response, and tolerability for treatment of glabellar lines. METHODS Adults with moderate or severe glabellar lines treated with DaxibotulinumtoxinA for Injection (DAXI) or placebo from the randomized, double-blind SAKURA 1/2 trials and the open-label SAKURA 3 safety study were analyzed by prior BoNTA treatment status. Efficacy was evaluated using investigator and participant assessments. RESULTS In this analysis, 609 participants (52.2% BoNTA-experienced) from the SAKURA 1/2 trials and 2,380 (38.0% BoNTA-experienced) from the SAKURA 3 study were evaluated. Proportion of participants with none or mild glabellar lines and duration of response were similar between the BoNTA-naive and BoNTA-experienced cohorts in both the DAXI and placebo groups. The incidence of adverse events was also comparable regardless of prior BoNTA treatment status. CONCLUSION Efficacy and tolerability were similar with DAXI and placebo regardless of prior BoNTA treatment. Assuming an appropriate washout is observed, future BoNTA trials should enroll both treatment-experienced and treatment-naive participants to reflect clinical practice.
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Phase I/III Clinical Trial to Evaluate the Safety and Efficacy of a New Botulinum Toxin (HU-014) Versus OnabotulinumtoxinA in Subjects With Moderate-to-Severe Crow's Feet Lines

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imageBACKGROUND HU-014, a newly introduced botulinum toxin type A, has not been investigated for its efficacy and safety in crow's feet line (CFL) treatment. OBJECTIVE Here, we compared the efficacy and safety of HU-014 and onabotulinumtoxinA in CFL treatment. METHODS This was a randomized, double-blind, active drug–controlled, multicenter, 16-week, Phase I/III study designed to determine the noninferiority of HU-014 compared with onabotulinumtoxinA in moderate-to-severe CFL treatment. In the Phase III study, 290 subjects were randomized at a 1:1 ratio to receive a single treatment of HU-014 or onabotulinumtoxinA. The primary endpoint was the proportion of subjects achieving Grade 0 or 1 in the facial wrinkle scale on maximum smile at Week 4. RESULTS The primary endpoint was achieved by 72% of the subjects with HU-014 and onabotulinumtoxinA treatments, supporting the noninferiority of HU-014 compared with onabotulinumtoxinA. All secondary efficacy outcomes were achieved by the subjects. The 2 groups showed no significant differences in the safety analysis. CONCLUSION HU-014 has noninferior efficacy and safety compared with onabotulinumtoxinA in the treatment of CFL.
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Melanoma Treated With Mohs Micrographic Surgery Using a Novel-Modified 15-Minute MART-1 Immunostain: Discussion of Technique and Experience

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imageNo abstract available
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A Multicenter Study to Evaluate Subject Satisfaction With Two Treatments of AbobotulinumtoxinA a Year in the Glabellar Lines

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imageBACKGROUND Real-world re-treatment intervals for botulinum toxins vary, but most subjects receive treatment less frequently than the manufacturer-recommended minimum intervals. In subjects receiving treatment with AbobotulinumtoxinA (ABO) less frequently, high levels of satisfaction and psychosocial improvements in well-being, self-confidence, and quality of life are observed. OBJECTIVE To evaluate subject satisfaction with a twice yearly re-treatment schedule. METHODS AND MATERIALS This open-label, multicenter, interventional study evaluated subject satisfaction following injections of ABO 50 U in the glabellar lines at baseline and 6 months. The primary end point was subject satisfaction at 12 months. Secondary endpoints included subject satisfaction, FACE-Q scales, and glabellar line severity scale (GLSS). RESULTS Ninety-five percent of the 120 subjects were "highly satisfied" or "satisfied" with their treatment outcomes at 12 months. FACE-Q total scores suggested that subjects were less bothered by glabellar lines and felt better about their facial appearance with each treatment versus baseline. Approximately half of subjects had ≥1-grade improvement from baseline in GLSS at 12 months. Median onset of effect was 2 days. CONCLUSION The majority of subjects (95%) were satisfied with ABO treatment every 6 months; results were supported by high subject satisfaction, long duration, rapid onset, natural-looking results, and overall psychological wellness and safety.
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Unusual Calcification Mimicking Periosteal Tumor Invasion in a Squamous Cell Carcinoma Treated With Mohs Micrographic Surgery

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Safety Profile of Combined Same-Day Treatment for Botulinum Toxin With Full Face Nonablative Fractionated Laser Resurfacing

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BACKGROUND Spread of botulinum toxin outside the treated muscle is a concern, when energy-based device treatment is performed on the same day as toxin injection. OBJECTIVE We assessed the frequency of eyelid ptosis after the glabella/periorbital botulinum toxin injection and nonablative fractionated laser performed at the same session. METHODS AND MATERIALS This single-center, retrospective study identified treatments consisting of glabella and/or periorbital botulinum toxin injection and nonablative fractionated laser treatment to full face from 2017 to 2019 and eyelid ptosis determined by documentation of the complication at a follow-up encounter, or prescription of apraclonidine. RESULTS Six hundred sixteen treatments of glabella/periorbital botulinum toxin injection and full-face nonablative fractionated laser on the same day on 393 individuals were identified. Five hundred eighty treatments (94%) included botulinum toxin injected in the glabella, 541 (88%) in the periorbital areas, and 508 (82%) in the forehead. Nonablative fractionated lasers used to treat the cohort were a 1,927-nm thulium and a 1,550-nm er:glass laser. Eyelid ptosis complication was documented in one case (0.2%) following the combined laser and toxin treatment. CONCLUSION The risk of spread of glabella/periorbital botulinum toxin to an unintended muscle was minimal in the setting of the concomitant full-face nonablative fractionated laser.
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Rate and Proportion of Malignant Skin Biopsies for Basal Cell and Squamous Cell Carcinoma on the Face and Ears After a Single Course of Topical 5-Fluorouracil: The Veterans Affairs Keratinocyte Carcinoma Chemoprevention Trial

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Combined Treatment of Rolling Acne Scars in Ethnic Skin Using Extensive Subcision, Trichloracetic Acid Peel, and Fractional Ablative Erbium Laser

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imageBACKGROUND Successful treatment of acne scars in ethnic skin requires procedures that are safe and effective with a low incidence of hyper or hypopigmentation postoperatively. OBJECTIVE In this study, the safety and efficacy of a combined treatment protocol including tumescent anesthesia, subcision, trichloracetic acid peel, and fractional erbium laser resurfacing was evaluated. METHODS This is a retrospective study of 56 patients (22 women and 34 men) with predominantly rolling acne scars and Fitzpatrick skin Types IV–VI who were treated using a combination of tumescent anesthesia, extensive subcision, fractional ablative erbium laser, and a blending 20% trichloracetic acid (TCA) peel. RESULTS The mean improvement after a single treatment, assessed by 3 independent evaluators (2 dermatologist and 1 dermatology physician assistant), was 2.52 (SD = 1.04) on a scale of 1 to 4. CONCLUSION The combination of tumescent anesthesia, extensive subcision, fractional ablative erbium laser resurfacing, and a blending 20% TCA peel (combined procedure) is both safe and effective in the treatment of rolling acne scars in ethnic skin types with acceptable temporary adverse effects.
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Does Double-Pass Pulsed-Dye Laser With Long and Short Pulse Duration Increase Treatment Efficacy of Port-Wine Stain? A Randomized Clinical Trial

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imageBACKGROUND Although pulsed-dye laser (PDL) 595 nm is known as the gold standard for treatment of port-wine stains (PWS), complete clearance of lesions occurs in a minority of cases. OBJECTIVE To compare the efficacy and safety of double-pass pulsed-dye laser (DPL), long pulse duration (20 m/s) followed by short pulse duration (1.5 m/s) within 20 minutes interval, with single-pass pulsed-dye laser (SPL) for (1.5 m/s) in the treatment of PWS. METHODS Twenty-four patients with PWS underwent 3 sessions of PDL. Each lesion was randomly divided into 2 portions to receive DPL or SPL. Colorimetric and dermoscopic evaluations were used to determine the response objectively. In addition, improvement was scored subjectively using the visual analog scale (VAS). RESULTS According to colorimetric analysis, the mean blanching rates for DPL and SPL treated sites were 48% (SD = 0.215) and 37% (SD = 0.213), respectively (p = .001). With VAS, 3.79 (SD = 0.93) and 3.33 (SD = 0.91) improvement scores were reported in the DPL and SPL treated areas, respectively (p = .008). Dermoscopic images showed that larger deep vessels were the most common remnant vessels in both treatment areas. CONCLUSION Compared with SPL, DPL with 20 minutes interval seems to be a more effective and safe method for the treatment of PWS.
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Poly-l-Lactic Acid Preinjection Aspiration as a Safety Checkpoint

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Vaginal Rejuvenation: A Retrospective Review of Lasers and Radiofrequency Devices

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imageBACKGROUND Vaginal rejuvenation is a topic of interest to multiple specialties, including dermatologists, plastic and reconstructive surgeons, urologists, and gynecologists. Evidence suggests that minimally invasive, energy-based devices—radiofrequency and laser therapy—are effective at vaginal tightening and decreasing symptoms of genitourinary syndrome of menopause (GSM) and/or vulvovaginal atrophy (VVA). MATERIALS AND METHODS A systematic review was completed using PubMed in November 2018 with search terms "vaginal" or "vagina" and "rejuvenation" or "tightening" or "laxity" or "radiofrequency" or "laser," as well as "genitourinary syndrome of menopause," "pelvic prolapse," "atrophic vaginitis," "vulvovaginal atrophy," "sexual function," "urinary incontinence," and "radiofrequency" or "laser." Inclusion criteria were articles written in English and clinical trials or case reports/series dealing with human subjects. RESULTS We identified 59 studies (3,609 women) treated for vaginal rejuvenation using either radiofrequency or fractional ablative laser therapy. Studies report improvement in symptoms of GSM/VVA and sexual function, high patient satisfaction, and minor adverse events, including treatment-associated pain, swelling, or vaginal discharge. CONCLUSION This review demonstrates radiofrequency and laser are efficacious for the treatment of vaginal laxity and/or atrophy. Further research needs to be completed to determine which specific pathologies can be treated, if maintenance treatment is necessary, and long-term safety concerns.
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Treatment of Angiolymphoid Hyperplasia With Eosinophilia With Pulsed Dye Laser

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