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BACKGROUND: Obesity and localized fat accumulation continue to drive the demand for minimally invasive body contouring technologies including injectable compounds for local fat reduction. siRNA offers a potential for an injectable to specifically target and silence genes involved in adipogenesis with minimal inflammatory side effects. AIMS: This study evaluates the efficacy of STP705, an injectable containing siRNA encapsulated within histidine-lysine polypeptide (HKP) nanoparticles targeting transforming growth factor ß1 (TGF-ß1) and cyclooxygenase-2 (COX-2), crucial mediators in adipocyte differentiation and fat retention, using in vitro, porcine, and murine models. METHODS: In vitro experiments on mouse preadipocytes and in vivo trials using Diet Induced Obese (DIO) mice and Yucatan minipigs were conducted to assess the gene silencing efficiency, tissue localization, pharmacodynamics, and safety profile of STP705. RESULTS: STP705 effectively reduced the expression of TGF-ß1 and COX-2, with a notable decrease in adipocyte volume and lipid content without adverse systemic effects. In DIO mice, the HKP-siRNA complex demonstrated precise localization to injected adipose tissue, maintaining significant gene silencing, and detectable levels of siRNA for up to 14 days post-administration. Similar results in minipigs showed a significant reduction in subcutaneous adipose tissue thickness. CONCLUSION: The results of these studies support the use of targeted siRNA therapy specifically targeting TGF-ß1 and COX-2, for localized fat reduction, offering a potential minimally invasive alternative to current fat reduction methods.
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BACKGROUND: TikTok is one of the fastest-growing social media platform, and its short-form videos have become a widely used source of health information. "Dermarolling" is a form of roller microneedling often practiced at home, and patients may be using TikTok to inform their decision to pursue this treatment and their practice of it. AIMS: This study assessed the informational content quality, source, and engagement of TikTok dermarolling videos to highlight potentially harmful social media trends. METHODS: On a predetermined date, "dermarolling" was searched on TikTok. The top 75 results were screened. Number of views, creator type, type of video, and whether risks were discussed were recorded. Information quality was assessed using the DISCERN tool. The data were stratified by creator type, and statistical analysis was performed using R version 4.3.2. Median viewership and DISCERN scores were compared using Kruskal-Wallis tests with post hoc pairwise Wilcoxon tests. Fisher's exact test was used to compare rates of risk discussion between groups. RESULTS: Sixty-one of the reviewed videos met the inclusion criteria. Influencer videos engaged the largest overall audience and had higher median viewership than other creators. Physicians, primarily dermatologists, created exclusively educational content and influencers created mostly experience-based content. Overall content quality was generally low-moderate, with a median (IQR) DISCERN score of 30.5 (26.5-33.5). Physician content had higher median DISCERN scores than influencers (p = 0.004) and others (p = 0.004). Physicians were more likely to discuss risks compared to influencers (p = 0.02). CONCLUSIONS: TikTok content on "dermarolling" was of relatively low quality, and nonphysicians command a large viewership. Physician-created content is often of higher informational quality, and dermatologists should escalate their efforts to engage patients in this space to mitigate the effects of potential misinformation.
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Agulhas , Mídias Sociais , Gravação em Vídeo , Humanos , Estudos Transversais , Técnicas Cosméticas/instrumentação , Informação de Saúde ao Consumidor/normas , Educação de Pacientes como Assunto/métodos , Indução Percutânea de ColágenoRESUMO
BACKGROUND: Hyperfunctional glabellar frown lines can transmit facial miscues that adversely affect emotional communication, increase perceptions of age, and diminish self-esteem. OBJECTIVE: To evaluate the efficacy of letibotulinumtoxinA in mitigating the negative psychological impact associated with moderate to severe glabellar lines and to assess subject satisfaction with treatment outcome in the BLESS phase 3 clinical trials. MATERIALS AND METHODS: Baseline and posttreatment assessments were made using validated subject-administered instruments: Modified Skindex-16 Glabellar Line Quality of Life (GL-QoL) Scale, Facial Assessment and Cosmetic Evaluation Questionnaire (FACE-Q) Appraisal of Lines Between Eyebrows Scale, FACE-Q Age Appraisal Visual Analog Scale, and FACE-Q Satisfaction with Outcome Scale. An integrated analysis using pooled BLESS data was conducted on these secondary end points. RESULTS: Among enrolled and treated subjects ( N = 1,272), 85.5% had moderate to severe psychological impact at baseline. LetibotulinumtoxinA subjects experienced significant improvements compared with placebo on all measures. Mean improvement to Week 4 for the Modified Skindex-16 GL-QoL Scale overall score was -33.84 for letibotulinumtoxinA subjects compared with -1.37 for placebo subjects ( p < .001). Attenuation of psychological burden was highly correlated with improvement in glabellar line severity ( p < .0001). CONCLUSION: LetibotulinumtoxinA significantly improved the psychosocial burden associated with glabellar lines across all trials. Treated subjects experienced improved quality of life, younger perceived age, and satisfaction with treatment outcome.
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Toxinas Botulínicas Tipo A , Testa , Satisfação do Paciente , Qualidade de Vida , Envelhecimento da Pele , Humanos , Toxinas Botulínicas Tipo A/administração & dosagem , Feminino , Masculino , Pessoa de Meia-Idade , Envelhecimento da Pele/efeitos dos fármacos , Adulto , Resultado do Tratamento , Método Duplo-Cego , Idoso , Inquéritos e Questionários , Técnicas Cosméticas/psicologia , Fármacos Neuromusculares/administração & dosagemRESUMO
Background: Botulinum toxin type A (BoNT-A) injections continue to be widely used as a common treatment for both males and females. According to a recent survey conducted by the International Society of Plastic Aesthetic Surgeons, the majority of patients receiving these injections are females between the ages 35 and 50. Objectives: A post hoc analysis was conducted to examine whether there were variances in the effectiveness and safety of letibotulinumtoxinA for treating vertical glabellar lines between the broader female study population and a particularly defined group of female participants aged 35 to 50. Methods: For this post hoc analysis, data from females aged 35 to 50 were extracted and analyzed from the BLESS III study. In this Phase 3 clinical trial, 355 participants with moderate-to-severe glabella frown lines received either 20â U of letibotulinumtoxinA or a placebo. The study evaluated Glabella Line Severity (GLS) score, treatment onset, duration of effects, time to retreatment, and adverse events. A positive response was determined by achieving a GLS score of 0 or 1, as assessed by both patients and investigators, along with at least a 2-point improvement in GLS score relative to baseline at Week 4 after the injections. Results: Composite responder rates for patients aged 35 to 50 receiving active treatment were significantly higher than for the remaining female population receiving active treatment at Weeks 1, 2, and 4. Females aged 35 to 50 showed higher rates of GLS improvement of ≥1 at Weeks 1, 2, 4, 8, 12, 16, and 20 compared with the remaining female population receiving active treatment. At Week 4, a higher percentage of females aged 35 to 50 achieved a GLS score of 0 upon maximum frowning compared with the remaining females. Females aged 35 to 50 had a shorter median time to onset of GLS improvement compared with the remaining female population. Safety assessments showed a low incidence of treatment-related adverse events in females aged 35 to 50. Conclusions: LetibotulinumtoxinA showed significantly higher response rates in females aged 35 to 50 compared with other female patients at Weeks 1, 2, and 4. Response rates remained higher up to Week 16. The treatment demonstrated efficacy and safety in treating vertical glabellar lines in this patient group.
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Background: Onychomycosis is a fungal infection of the nail unit that affects a large patient population globally. Onychomycosis, or tinea unguium, has a benign chronic clinical course; however, it can cause complications in certain patient populations suffering from diabetes and peripheral vascular disease. As nails grow slowly, onychomycosis requires a lengthy treatment plan, and choosing appropriate treatments can be challenging. There are a variety of treatment modalities available for patients including topical, oral, laser, light therapy, procedures such as avulsion and matrixectomy, supplements, over-the-counter medication, and plasma therapy that can be used as monotherapy or in combination for patient satisfaction. Objective: We sought to review treatment options for onychomycosis, taking into consideration the efficacy, side effect profiles, practicality of treatment (adherence), and costs to help healthcare providers offer ethically appropriate treatment regimens to their patients. Methods: A literature search was conducted using electronic databases (PubMed, Embase, Medline, CINAHL, EBSCO) and textbooks, in addition to the clinical experiences of the authors and other practitioners in treating onychomycosis, and a summary of the findings are presented here. Results: Although topical (efinaconazole, tavaborole, ciclopirox), oral (terbinafine, itraconazole), and laser (1064nm Nd:YAG lasers, both short-pulsed and Q-switched lasers, carbon dioxide lasers, and the diode 870, 930nm) are the current Food and Drug Administration (FDA)-approved treatments for onychomycosis, they are just a fraction of available treatment options. New and emerging therapies including new topical and oral medications, combination therapy, photodynamic light therapy, procedural, supplements, over-the-counter medication, and plasma therapy are discussed in our review. Discussion: Onychomycosis has high reinfection and recurrence rates, and the treatment remains challenging as treatment selection involves ethical, evidence-based decision-making and consideration of each individual patient's needs, adherence, budget, the extent of quality of life discomfort, and aesthetic goals, independent of potential financial benefits to the clinicians.
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Objective: We sought to examine the role of flavonoids, particularly diosmin, as a therapeutic agent for stasis dermatitis (SD) through discussion of pathophysiology, current treatment paradigms, potential mechanisms of action, and a systematic review of evidence on clinical efficacy. Methods: In addition to articles on pathophysiology and standard treatment, a search of PubMed was conducted using the following query: ("Diosmin" OR "MPFF" OR "Micronized Purified Flavonoid Fraction" OR "Flavonoid") AND ("Stasis Dermatitis" OR "Venous Ulcer" OR "Lipodermatosclerosis"). Emphasis was placed on studies that were randomized controlled trials examining an oral flavonoid against a placebo or standard of care. Results: Diosmin is effective at improving stasis changes, increasing ulcer healing frequency, decreasing the time to ulcer healing, and reducing tissue edema. They also cause significant improvement in patient quality of life and reduction of venous symptoms. Diosmin has been shown to have a favorable safety profile with very few mild adverse events which did not differ significantly from placebo. Flavonoids also appear to be effective for other dermatologic conditions, including rosacea and senile purpura. Conclusion: There is a growing body of evidence indicating that diosmin has therapeutic efficacy in managing stasis dermatitis. Data from studies in diseases with pathogenic similarities suggests the potential for even broader dermatologic applications.
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BACKGROUND: The demand for nonsurgical facial rejuvenation options is growing, yet the periorbital region remains an area of relative unmet need. This review explores nonsurgical options for facial rejuvenation and the role of oxymetazoline hydrochloride ophthalmic solution, 0.1%, in treating age-related blepharoptosis as part of periorbital rejuvenation. METHODS: Advisors experienced in facial rejuvenation met to discuss existing literature on the upper face and periorbital rejuvenation and the role of oxymetazoline hydrochloride ophthalmic solution, 0.1%, in treating facial aging. RESULTS: An array of nonsurgical options exist to address the signs of aging, including minimally invasive treatments, such as botulinum toxin injections and dermal fillers, and noninvasive therapy, such as lasers, chemical peels, and microdermabrasion. However, treating age-related ptosis in periorbital rejuvenation is mainly addressed surgically. The newly approved α-adrenergic receptor agonist oxymetazoline hydrochloride ophthalmic solution, 0.1%, provides a novel non-interventional approach to blepharoptosis. CONCLUSIONS: Facial rejuvenation is highly sought-after in this post-pandemic era. Each nonsurgical treatment option has its advantages and drawbacks. A patient-centered approach is necessary to select the appropriate procedure considering the patient's concerns and aesthetic sensibilities. The eyes are an area of primary concern for patients, yet surgery is the gold standard for treating ptosis. Oxymetazoline hydrochloride ophthalmic solution, 0.1%, is a safe and effective nonsurgical treatment for blepharoptosis.
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Blefaroptose , Toxinas Botulínicas Tipo A , Técnicas Cosméticas , Preenchedores Dérmicos , Envelhecimento da Pele , Humanos , Técnicas Cosméticas/efeitos adversos , Oximetazolina/uso terapêutico , Rejuvenescimento , Blefaroptose/etiologia , Blefaroptose/terapia , Soluções OftálmicasRESUMO
BACKGROUND: Noninvasive body contouring is becoming more popular in the United States as an alternative to liposuction. The most popular of these methods, cryolipolysis, uses precisely controlled cooling to reduce focal adiposities. The number of cryolipolysis procedures performed annually has experienced rampant growth in United States markets, and the indications have likewise diversified. In light of this change, it is imperative to perform an updated review of available US safety and efficacy data on cryolipolysis. AIMS: To examine the safety and efficacy of cryolipolysis treatments in the United States using data extracted from research performed exclusively at US-based sites. METHODS: In order to identify relevant studies, a literature search was conducted on PubMed using the terms "CoolSculpting" OR "cryolipolysis" OR "lipocryolysis." Articles were manually reviewed to exclude literature reviews, research not performed on humans, studies on experimental combinations of techniques, and any studies not performed in the United States. RESULTS: The initial literature search returned 246 results. Following manual review, a total of 18 studies were selected for data extraction. Mean reduction in fat thickness by ultrasound was 2.0-5.1 mm or 19.6%-32.3%; mean reduction by body caliper was 2.3-7 mm or 14.9%-21.5%. Side effects were mild and transient. Four instances of PAH were documented in 3453 treatment cycles. CONCLUSIONS: Cryolipolysis is a safe, modestly effective method for reducing focal adiposity. Complications are rare and treatable. However, US-based studies are few in number and often of low power and/or quality. More high-quality research is needed for all aspects of cryolipolysis.
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Contorno Corporal , Lipectomia , Humanos , Crioterapia/efeitos adversos , Crioterapia/métodos , Gordura Subcutânea/cirurgia , Lipectomia/efeitos adversos , Lipectomia/métodos , Obesidade/etiologia , Resultado do TratamentoRESUMO
BACKGROUND: Squamous cell carcinoma (SCC) is the second most common cutaneous malignancy, after basal cell carcinoma (BCC). Photodynamic therapy (PDT) involves converting a photosensitizer to reactive oxygen intermediates, which preferentially bind to hyperproliferative tissue. The most commonly used photosensitizers are methyl aminolevulinate and aminolevulinic acid (ALA). Presently, ALA-PDT is approved in the US and Canada for the treatment of actinic keratoses on the face, scalp, and upper extremities. AIMS: This cohort study evaluated the safety, tolerability, and efficacy of aminolevulinic acid, pulsed dye laser, and photodynamic therapy (ALA-PDL-PDT) for treatment of facial cutaneous squamous cell carcinoma in situ (isSCC). METHODS: Twenty adult patients with biopsy-confirmed isSCC on the face were recruited. Only lesions 0.4-1.3 cm in diameter were included. Patients underwent two treatments with ALA-PDL-PDT spaced 30 days apart. The isSCC lesion was then excised 4-6 weeks following the second treatment for histopathological assessment. RESULTS: No residual isSCC was detected in 17/20 (85%) patients. Two of the patients with residual isSCC had skip lesions present that explained the treatment failure. Excluding the patients with skip lesions, the posttreatment histological clearance rate was 17/18 (94%). Minimal side effects were reported. LIMITATIONS: Our study was limited by small sample size and lack of long-term recurrence data. CONCLUSIONS: The ALA-PDL-PDT protocol is a safe and well-tolerated treatment option for isSCC on the face, providing excellent cosmetic and functional results.
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Carcinoma de Células Escamosas , Lasers de Corante , Fotoquimioterapia , Neoplasias Cutâneas , Adulto , Humanos , Ácido Aminolevulínico , Fotoquimioterapia/efeitos adversos , Fotoquimioterapia/métodos , Carcinoma de Células Escamosas/terapia , Estudos de Coortes , Lasers de Corante/efeitos adversos , Neoplasias Cutâneas/etiologia , Fármacos Fotossensibilizantes , Resultado do TratamentoRESUMO
INTRODUCTION: Frontline Healthcare provider (HCP) burnout has dramatically increased due to the COVID 19 pandemic. Hospitals are supporting wellness programs and techniques to reduce burnout including the Transcendental Meditation (TM) technique. This study evaluated the use of TM on HCP symptoms of stress, burnout and wellness. METHODS: A total of 65 HCPs at three South Florida hospitals were recruited and instructed in the TM technique which they practiced at home for 20 minutes twice a day. A parallel lifestyle as usual control group was enrolled. Validated measurement scales (Brief Symptom Inventory 18 (BSI-18), Insomnia Severity Index (ISI), Maslach Burnout Inventory-Human Services Survey [MBI-HSS (MP)] and the Warwick Edinburgh Mental Well Being Scale (WEMWBS) were administered at baseline, 2 weeks, one and three months. RESULTS: No significant demographic differences were seen between the 2 groups; however, some baseline scales were higher in the TM group. TM average weekly session completion rate was very high at 83%. After 2-weeks, symptoms of somatization, depression, and anxiety in the TM group had all shown near 45% reductions, while insomnia, emotional exhaustion, and well-being had improved by 33%, 16%, and 11% respectively (P = 0.02 for somatization and < .001 for all others); no significant change was noted in the LAU group. At 3-months, in the TM group, the improvement in symptoms showed a mean reduction of in anxiety, 62%, somatization, 58%, depression, 50%, insomnia, 44%, emotional exhaustion 40%, depersonalization, 42%, and improvement of well-being 18% (for all p<0.004). P-values for between-group differences in change from baseline, based upon repeated measures ANCOVA covarying for baseline measurements, showed significance for all scales at 3-months. CONCLUSION: The study confirmed the reported significant and rapid benefits of the practice of TM and demonstrated its positive psychological impact on healthcare workers in a high stress setting.
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COVID-19 , Meditação , Distúrbios do Início e da Manutenção do Sono , Humanos , Saúde Mental , Pandemias , Pessoal de SaúdeRESUMO
BACKGROUND AND OBJECTIVES: This feasibility study describes the effects of Nano-pulse stimulation™ (NPS™) technology using the CellFX™ System on acne vulgaris of the back with the objectives of demonstrating safety and effectiveness. The CellFX System applies nanosecond pulses of electrical energy to induce highly localized regulated cell death (RCD) in the cellular structures of the targeted zone with no thermal effect on the tissue and negligible effects on surrounding non-cellular components. STUDY DESIGN/MATERIALS AND METHODS: Seventeen subjects were enrolled at two sites with thirteen subjects completing treatment. Three 7 X 7 cm regions containing at least five bacne lesions each were identified, one region treated with the CellFX across three treatment sessions, the second region treated as a sham using microneedle tip placement without delivering energy, and the third as an untreated control. RESULTS: CellFX-treated areas showed an average reduction of acne lesions of 82% by 90 days post-last procedure. Acne improvement was observed in 100% of CellFX-treated regions compared to 39% improvement in Sham regions and 31% improvement in the control regions. The most common skin effects were erythema and hyperpigmentation observed in 23% and 92% of the subjects, respectively, at the last timepoint. No serious adverse events were reported. CONCLUSIONS: CellFX is a safe and effective procedure for clearing back acne.
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Acne Vulgar , Terapia com Luz de Baixa Intensidade , Humanos , Resultado do Tratamento , Acne Vulgar/terapia , Acne Vulgar/patologia , Pele/patologia , Terapia com Luz de Baixa Intensidade/métodos , EritemaRESUMO
Objective: Dermatology and aesthetic medicine has experienced significant growth in recent years, driven by industry-sponsored research performed by clinical investigators. Contract research organizations (CROs) play an important role to ensure clinical trials are run efficiently, ethically, and according to Good Clinical Practice. An advisory group of dermatologists and aesthetic researchers was assembled to obtain feedback about CRO experiences for developing a "next-generation" specialty CRO for dermatology and aesthetic medicine. Methods: Experienced dermatologists and aesthetic physician researchers convened during the 2022 Winter Dermatology Annual Meeting in Kauai, Hawaii, to discuss experiences and make suggestions regarding CROs. Topics included positive and negative aspects of CRO experiences, desirable CRO services, and how CROs can be improved. Results: Benefits of working with CROs include project, data, and resource management and availability of technology. Desired functions include rapid study start-up, subject recruitment, and accurate and organized site-related documentation. Other qualities include access to large subject populations close to study locations, use of CRO-based clinical research assistants to support principal investigators across study sites, and scientific consultation, protocol development, medical writing, project management, clinical and medical monitoring, data management, biostatistics, and pharmacovigilance. Conclusion: CROs serve a vital role in the development process of drug, device, and therapeutics; however, it is important that changes to traditional CRO models are made to provide improved interactions with researchers in dermatology and aesthetic medicine.
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This single-center, open label, dose escalation cohort study evaluated the safety and efficacy of various doses of intralesional injections of TGF-β1/COX-2 combined with histidine-lysine polypeptide (siRNA/HKP) nanoparticle silencing therapeutic in patients with cutaneous in situ squamous cell carcinoma. Twenty-five patients (mean age: 67, SD: 10 years; 52% men) with cutaneous in situ squamous cell carcinoma participated. TGF-β1/COX-2 siRNA/HKP nanoparticle therapeutic was injected weekly for up to 6 weeks based on the following dosing cohorts: 10 μg/treatment, 20 μg/treatment, 30 μg/treatment, 60 μg/treatment, and 120 μg/treatment. The primary endpoint was the proportion of subjects with complete histological clearance. Also evaluated were the incidence/severity of treatment emergent adverse events and serious adverse events and incidence/severity of Local Skin Response. Twenty-five subjects received the TGF-β1/COX-2 siRNA/HKP nanoparticle therapeutic; 19 (76%) achieved histological clearance. In the 30 μg/treatment group and 60 μg/treatment group, percent cleared was 80% and 100%, respectively. Five subjects had 7 adverse events. There were no severe or serious adverse events; none led to treatment discontinuation, study interruption, or were related to the investigational product. Local skin response was none to minimal in most subjects, with improvement observed in the 10 μg/treatment, 20 μg/treatment, 30 μg/treatment, and 60 μg/treatment cohorts. Intralesional TGF-β1/COX-2 siRNA/HKP nanoparticle therapeutic injections appear to be noninvasive, safe, and efficacious in treating cutaneous in situ squamous cell carcinoma. The recommended doses for future study of the investigational product are 30 μg/treatment and 60 μg/treatment. J Drugs Dermatol. 2022;21(5):472-477. doi:10.36849/JDD.6384.
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Carcinoma de Células Escamosas , Neoplasias Cutâneas , Adulto , Idoso , Carcinoma de Células Escamosas/tratamento farmacológico , Carcinoma de Células Escamosas/genética , Estudos de Coortes , Ciclo-Oxigenase 2 , Feminino , Humanos , Masculino , RNA Interferente Pequeno/efeitos adversos , RNA Interferente Pequeno/genética , Neoplasias Cutâneas/tratamento farmacológico , Neoplasias Cutâneas/genética , Fator de Crescimento Transformador beta1/genética , Fator de Crescimento Transformador beta1/uso terapêuticoRESUMO
This is a report of the survey results from the International Dermatology Outcome Measures (IDEOM) actinic keratosis (AK) workgroup. The purpose of the survey was to compile a list of gaps within AK care and management that require refinement. The results were discussed at the IDEOM annual meeting held virtually on October 23–24, 2020. This built a framework with which the AK workgroup, which consisted of physicians, patients, and pharmaceutical scientists, discussed at length in their breakout session at the meeting. The electronic survey was distributed to patients, pharmaceutical scientists, and leading physician experts in the field via email on September 22, 2020, with a deadline of October 2, 2020. The survey consisted of three open-ended prompts concerning key gaps and/or unmet needs in (1) the care of AKs, (2) outcome measurement of AKs in clinical trials and, (3) the measurement of AKs in clinical practice. The results were qualitative, with a response rate of 47%. Responses included reform of outcome measures for clinical trials, a methodology for evaluating the efficacy of preventative measures, and a comparison of treatments to establish a treatment protocol, among other efforts. This paper will also provide a brief overview of the current state of the AK outcome measures, emphasizing the heterogeneity of the measures and detailing the AK workgroup's future efforts to create a reliable and applicable core outcome measure set. J Drugs Dermatol. 2022;21(2):128-134. doi:10.36849/JDD.6360.
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Ceratose Actínica , Humanos , Ceratose Actínica/tratamento farmacológico , Avaliação de Resultados em Cuidados de Saúde , Inquéritos e QuestionáriosRESUMO
BACKGROUND: Letibotulinumtoxin A (Hugel, Inc., Chuncheon, Republic of Korea and CROMA Pharma, Leobendorf, Austria) is a newly manufactured neurotoxin derived from Clostridium botulinum strain CBFC26. OBJECTIVES: The aim of this study was to assess the efficacy and safety of letibotulinumtoxin A in reducing glabellar line severity (GLS) and to evaluate long-term safety and efficacy following repeated injections. METHODS: In this prospective, randomized, parallel-group, double-blind, multicentre, placebo-controlled Phase III clinical trial, 355 subjects with moderate to severe glabella frown lines received injections of 20 U of letibotulinumtoxin A or placebo. GLS, onset and duration of effect, time to retreatment, and adverse events were evaluated. Response to treatment was defined as a GLS score of 0 or 1 (assessed by the subject and the investigator) and an improvement at Week 4 of ≥2 points in GLS score relative to baseline. RESULTS: At 4 weeks, 78.6% of the active treatment subjects were responders based on the investigator's assessment and 68.8% based on the subject's assessment, resulting in a composite responder rate of 64.7% for the active treatment group, whereas the corresponding rate was 0.0% in the placebo group (Pâ <â 0.001). Subjects noted a substantial improvement in GL severity as early as Day 2, with the median time to onset of effect being 3 days. The mean [standard deviation] time until first retreatment for the letibotulinumtoxin A group was 127.26 [65.6] days. Letibotulinumtoxin A was well tolerated. CONCLUSIONS: Letibotulinumtoxin A demonstrates high efficacy and a convincing safety profile in the treatment of glabellar lines.
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Toxinas Botulínicas Tipo A , Fármacos Neuromusculares , Envelhecimento da Pele , Toxinas Botulínicas Tipo A/efeitos adversos , Método Duplo-Cego , Testa , Humanos , Estudos Prospectivos , Resultado do TratamentoRESUMO
Objective: Dermatology and aesthetic medicine has experienced significant growth in recent years, driven by industry-sponsored research performed by clinical investigators. Contract research organizations (CROs) play an important role to ensure clinical trials are run efficiently, ethically, and according to Good Clinical Practice. An advisory group of dermatologists and aesthetic researchers was assembled to obtain feedback about CRO experiences for developing a "next-generation" specialty CRO for dermatology and aesthetic medicine. Methods: Experienced dermatologists and aesthetic physician researchers convened during the 2022 Winter Dermatology Annual Meeting in Kauai, Hawaii, to discuss experiences and make suggestions regarding CROs. Topics included positive and negative aspects of CRO experiences, desirable CRO services, and how CROs can be improved. Results: Benefits of working with CROs include project, data, and resource management and availability of technology. Desired functions include rapid study start-up, subject recruitment, and accurate and organized site-related documentation. Other qualities include access to large subject populations close to study locations, use of CRO-based clinical research assistants to support principal investigators across study sites, and scientific consultation, protocol development, medical writing, project management, clinical and medical monitoring, data management, biostatistics, and pharmacovigilance. Conclusion: CROs serve a vital role in the development process of drug, device, and therapeutics; however, it is important that changes to traditional CRO models are made to provide improved interactions with researchers in dermatology and aesthetic medicine.
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BACKGROUND: Androgenetic alopecia (AGA) is the most common form of hair loss consisting of a characteristic receding frontal hairline in men and diffuse hair thinning in women, with frontal hairline retention, and can impact an individual's quality of life. The condition is primarily mediated by 5-alpha-reductase and dihydrotestosterone (DHT) which causes hair follicles to undergo miniaturization and shortening of successive anagen cycles. Although a variety of medical, surgical, light-based and nutraceutical treatment options are available to slow or reverse the progression of AGA, it can be challenging to select appropriate therapies for this chronic condition. AIMS: To highlight treatment options for androgenetic alopecia taking into consideration the efficacy, side effect profiles, practicality of treatment (compliance), and costs to help clinicians offer ethically appropriate treatment regimens to their patients. MATERIALS AND METHODS: A literature search was conducted using electronic databases (Medline, PubMed, Embase, CINAHL, EBSCO) and textbooks, in addition to the authors' and other practitioners' clinical experiences in treating androgenetic alopecia, and the findings are presented here. RESULTS: Although topical minoxidil, oral finasteride, and low-level light therapy are the only FDA-approved therapies to treat AGA, they are just a fraction of the treatment options available, including other oral and topical modalities, hormonal therapies, nutraceuticals, PRP and exosome treatments, and hair transplantation. DISCUSSION: Androgenetic alopecia therapy remains challenging as treatment selection involves ethical, evidence-based decision-making and consideration of each individual patient's needs, compliance, budget, extent of hair loss, and aesthetic goals, independent of potential financial benefits to the practitioners.
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Alopecia em Áreas , Qualidade de Vida , Alopecia/tratamento farmacológico , Feminino , Finasterida/uso terapêutico , Folículo Piloso , Humanos , Masculino , Minoxidil/uso terapêuticoRESUMO
Keloid and hypertrophic scars are fibroproliferative disorders resulting from abnormal wound healing in genetically susceptible individuals. Current therapies are often ineffective. Kynurenine shows promise as a topical treatment for keloids and hypertrophic scars. In this study, healthy adult male and female subjects seeking treatment for mature keloid scars were enrolled. Subjects were randomized in double-blind fashion to receive kynurenic acid 0.5% (FS2) cream (Group 1), an active onion extract comparator treatment (Group 2), or the inactive vehicle (Group 3). Each treatment was applied twice-daily. Qualitative assessments were made using the Vancouver Scar Scale (VSS), as well as the Patient and Observer Scar Assessment Scales (POSAS). Among subjects in Group 1, there was a substantial decrease in mean PGSS scores after 30 days of treatment that continued to trend downward, becoming significant versus Group 2 at days 90 and 180 (P<0.05) and versus Group 3 at day 180 (P<0.01). Based on mean VSS scores, subjects in Group 1 achieved beneficial effects that became significant versus Group 2 at day 90 (P<0.01), day 120 (P<0.05), and day 180 (P<0.001) and versus Group 3 at day 180 (P<0.05). There were no significant improvements in Groups 2 or 3. There were no adverse events or local skin reactions. The twice-daily application of FS2 Cream represents a potentially new and effective treatment for mature keloid scars. J Drugs Dermatol. 2021;20(9):964-968. doi:10.36849/JDD.6197.
Assuntos
Cicatriz Hipertrófica , Queloide , Administração Tópica , Adulto , Cicatriz Hipertrófica/tratamento farmacológico , Método Duplo-Cego , Feminino , Humanos , Queloide/tratamento farmacológico , Queloide/patologia , Masculino , Pele/patologia , Resultado do TratamentoRESUMO
BACKGROUND: Botulinum toxin A (BoNT-A) has grown tremendously in aesthetic dermatology since 2002 when the United States Food and Drug Administration (FDA) first approved its use for treating moderate-to-severe glabellar lines. Blepharoptosis, due to local spread of toxin, is a reported side effect of BoNT-A which, although rare, more frequently occurs among inexperienced practitioners. OBJECTIVES: The purpose of this review is to highlight the causes and management of eyelid ptosis secondary to BoNT-A administration including new anatomic pathways for BoNT-A spread from the brow area to the levator palpebrae superioris muscle. METHODS: A literature search was conducted using electronic databases (PubMed, Science Direct, MEDLINE, Embase, CINAHL, EBSCO) regarding eyelid anatomy and the underlying pathogenesis, presentation, prevention, and treatment of eyelid ptosis secondary to BoNT-A. Anatomic dissection has been performed to assess the role of neurovascular pedicles and supraorbital foramen anatomic variations. RESULTS: Blepharoptosis occurs due to weakness of the levator palpebrae superioris muscle. Mean onset is 3-14 days after injection and eventually self-resolves after the paralytic effect of BoNT-A wanes. Administration of medications, such as oxymetazoline hydrochloride or apraclonidine hydrochloride eye drops, anticholinesterase agents, or transdermal BoNT-A injections to the pre-tarsal orbicularis, can at least partially reverse eyelid ptosis. Anatomic study shows that a supraorbital foramen may be present in some patients and constitutes a shortcut from the brow area directly into the orbital roof, following the supraorbital neurovascular pedicle. CONCLUSION: Providers should understand the anatomy and be aware of the causes and treatment for blepharoptosis when injecting BoNT-A for the reduction of facial wrinkles. Thorough anatomic knowledge of the supraorbital area and orbital roof is paramount to preventing incorrect injection into "danger zones," which increase the risk of eyelid ptosis.