RESUMO
BACKGROUND: Following the first investigational study on the use of extracorporeal photopheresis for the treatment of cutaneous T-cell lymphoma published in 1983, this technology has received continued use and further recognition for additional earlier as well as refractory forms. After the publication of the first guidelines for this technology in the JEADV in 2014, this technology has maintained additional promise in the treatment of other severe and refractory conditions in a multidisciplinary setting. It has confirmed recognition in well-known documented conditions such as graft-vs.-host disease after allogeneic bone marrow transplantation, systemic sclerosis, solid organ transplant rejection including lung, heart and liver and to a lesser extent inflammatory bowel disease. MATERIALS AND METHODS: In order to further provide recognized expert practical guidelines for the use of this technology for all indications, the European Dermatology Forum (EDF) again proceeded to address these questions in the hands of the recognized experts within and outside the field of dermatology. This was done using the recognized and approved guidelines of EDF for this task. All authors had the opportunity to review each contribution as it was added. RESULTS AND CONCLUSION: These updated 2020 guidelines provide at present the most comprehensive available expert recommendations for the use of extracorporeal photopheresis based on the available published literature and expert consensus opinion. The guidelines were divided into two parts: PART I covers Cutaneous T-cell lymphoma, chronic graft-vs.-host disease and acute graft-vs.-host disease, while PART II will cover scleroderma, solid organ transplantation, Crohn's disease, use of ECP in paediatric patients, atopic dermatitis, type 1 diabetes, pemphigus, epidermolysis bullosa acquisita and erosive oral lichen planus.
Assuntos
Dermatologia , Doença Enxerto-Hospedeiro , Linfoma Cutâneo de Células T , Fotoferese , Neoplasias Cutâneas , Criança , Humanos , Linfoma Cutâneo de Células T/terapiaRESUMO
BACKGROUND: Actinic keratosis (AK) is an early in situ epidermal cancer which can progress to invasive squamous cell carcinoma (SCC). Imiquimod 5% cream (IMIQ) and diclofenac 3% gel (DIC) are frequently used to treat AK; however, their long-term effects following repeated treatment cycles have never been compared. OBJECTIVE: To compare IMIQ and DIC in the treatment of AK with respect to the risk of change to grade III AK or invasive SCC, after 3 years. METHODS: Data were pooled from two randomized, active-controlled, open-label, multicentre, multinational, phase IV studies (Clinicaltrials.gov NCT00777127/NCT01453179), with two parallel groups. Studies were conducted between 2008 and 2015 and were almost identical in design. Patients eligible for inclusion were immunocompetent adults with 5-10 visible AK lesions on the face/scalp and grade I/II AK. The primary endpoint was inhibition of histological change to grade III AK or invasive SCC in the study treatment area, observed until month 36. Patients applied either IMIQ or DIC for a maximum of six treatment cycles. RESULTS: In total, 479 patients (IMIQ 242; DIC 237) were included in the full analysis set. Histological change to grade III AK or invasive SCC was observed until month 36 in 13 (5.4%) patients treated with IMIQ, compared with 26 (11.0%) patients treated with DIC (absolute risk difference -5.6% [95% confidence interval -10.7%, -0.7%]). Time to histological change was greater in the IMIQ group than the DIC group (P = 0.0266). Frequency of progression to invasive SCC was lower with IMIQ than with DIC at all time points. Initial clearance rate was higher in the IMIQ group compared with the DIC group, while recurrence rate was lower. Both treatments were well tolerated. CONCLUSIONS: Over 3 years, IMIQ was superior to DIC in clearing AK lesions and preventing histological change to grade III AK or invasive SCC and recurrence.
Assuntos
Adjuvantes Imunológicos/uso terapêutico , Anti-Inflamatórios não Esteroides/uso terapêutico , Diclofenaco/uso terapêutico , Neoplasias Faciais/prevenção & controle , Imiquimode/uso terapêutico , Ceratose Actínica/tratamento farmacológico , Idoso , Carcinoma de Células Escamosas/prevenção & controle , Feminino , Géis , Humanos , Ceratose Actínica/patologia , Masculino , Pessoa de Meia-Idade , Couro Cabeludo , Creme para a PeleRESUMO
The 2019 Interactive Derma Academy (IDeA) meeting was held in Lisbon, Portugal, 10-12 May, bringing together leading dermatology experts from across Europe, the Middle East and Asia. Over three days, the latest developments and challenges in relation to the pathophysiology, diagnosis, evaluation and management of dermatological conditions were presented, with a particular focus on acne, atopic dermatitis (AD) and actinic keratosis (AK). Interesting clinical case studies relating to these key topics were discussed with attendees to establish current evidence-based best practices. Presentations reviewed current treatments, potential therapeutic approaches and key considerations in the management of acne, AK and AD, and discussed the importance of the microbiome in these conditions, as well as the provision of patient education/support. It was highlighted that active treatment is not always required for AK, depending on patient preferences and clinical circumstances. In addition to presentations, two interactive workshops on the diagnosis and treatment of sexually transmitted infections/diseases (STIs/STDs) presenting to the dermatology clinic, and current and future dermocosmetics were conducted. The potential for misdiagnosis of STIs/STDs was discussed, with dermoscopy and/or reflectance confocal microscopy suggested as useful diagnostic techniques. In addition, botulinum toxin was introduced as a potential dermocosmetic, and the possibility of microbiome alteration in the treatment of dermatological conditions emphasized. Furthermore, several challenges in dermatology, including the use of lasers, the complexity of atopic dermatitis, wound care, use of biosimilars and application of non-invasive techniques in skin cancer diagnosis were reviewed. In this supplement, we provide an overview of the presentations and discussions from the fourth successful IDeA meeting, summarizing the key insights shared by dermatologists from across the globe.
Assuntos
Medicamentos Biossimilares , Dermatologia , Ásia , Europa (Continente) , Humanos , Oriente Médio , PortugalRESUMO
BACKGROUND: Following the first investigational study on the use of extracorporeal photopheresis for the treatment of cutaneous T-cell lymphoma published in 1983, this technology has received continued use and further recognition for additional earlier as well as refractory forms. After the publication of the first guidelines for this technology in the JEADV in 2014, this technology has maintained additional promise in the treatment of other severe and refractory conditions in a multi-disciplinary setting. It has confirmed recognition in well-known documented conditions such as graft-versus-host disease after allogeneic bone marrow transplantation, systemic sclerosis, solid organ transplant rejection including lung, heart and liver and to a lesser extent inflammatory bowel disease. MATERIALS AND METHODS: In order to further provide recognized expert practical guidelines for the use of this technology for all indications, the European Dermatology Forum (EDF) again proceeded to address these questions in the hands of the recognized experts within and outside the field of dermatology. This was done using the recognized and approved guidelines of EDF for this task. All authors had the opportunity to review each contribution as it was added. RESULTS AND CONCLUSION: These updated 2020 guidelines provide at present the most comprehensive available expert recommendations for the use of extracorporeal photopheresis based on the available published literature and expert consensus opinion. The guidelines are divided in two parts: PART I covers cutaneous T-cell lymphoma, chronic graft-versus-host disease and acute graft-versus-host disease while PART II will cover scleroderma, solid organ transplantation, Crohn's disease, use of ECP in paediatrics practice, atopic dermatitis, type 1 diabetes, pemphigus, epidermolysis bullosa acquisita and erosive oral lichen planus.
Assuntos
Dermatologia , Doença Enxerto-Hospedeiro , Linfoma Cutâneo de Células T , Fotoferese , Neoplasias Cutâneas , Criança , Doença Enxerto-Hospedeiro/prevenção & controle , Humanos , Linfoma Cutâneo de Células T/terapiaRESUMO
BACKGROUND: The members of the Task Force on Contact Dermatitis and the Task Force on Occupational Dermatoses of the European Academy of Dermatology and Venereology (EADV), of the European Dermatology Forum (EDF), and the members of the UEMS Section of Dermatology-Venereology (UEMS-EBDV) we want to vindicate the fundamental role that the specialist in Dermatology has in the diagnosis and management of Immuno-mediated /allergic Diseases. OBJECTIVE: In disagreement with the blueprint paper of the UEMS section of Allergology (2013), in which dermatologists are excluded from one of their core activities it was decided to write this consensus paper. DISCUSSION: The skin occupies a crucial place in the broad spectrum of allergic diseases; there is no other organ with such a multitude of different clinical conditions mediated by so many pathogenetic immune mechanisms. Subsequently, dermatologists play a fundamental role in the management of immune-mediated diseases including among others contact dermatitis, atopic dermatitis, urticaria and angioedema or cutaneous adverse drug, food and arthropod reactions. The essential role of dermatology in the diagnostic, therapeutic and preventive management of immune mediated /allergic diseases which is crucial for patient management is justified from both the academic and professional point of view. CONCLUSION: Based on the best care of the patient with cutaneous immune allergic disease a multidisciplinary approach is desirable and the dermatologist has a pivotal role in patient management. Be so good and no one will not ignore you, dermatologist. Ideally Dermatology should be governed according the following Henry Ford statement: "Arriving together is the beginning; keeping together is progress; working together is success."
Assuntos
Consenso , Dermatite de Contato/terapia , Dermatologistas , Hipersensibilidade/terapia , Doenças Profissionais/terapia , Papel do Médico , Comitês Consultivos , Alérgenos/efeitos adversos , Europa (Continente) , HumanosRESUMO
BACKGROUND: Cutaneous microdialysis (CM) is an ex vivo technique that allows study of tissue chemistry, including bioavailability of actual tissue concentration of unbound drug in the interstitial fluid of the body. AIM: To test the penetration and dermal bioavailability of galenic formulations of the small-molecule IP10.C8, a dual-protease inhibitor of the dipeptidyl peptidase and aminopeptidase families. METHODS: Using CM, we tested the penetration and dermal bioavailability of IP10.C8 into the dermis and subcutis of pigs, and determined the tissue concentration of IP10.C8 enzymatically, using an enzyme activity assay (substrate Gly-Pro-pNA) and high performance liquid chromatography. RESULTS: Dermal bioavailability was enhanced by using microemulsion or the addition of the penetration enhancer oleic acid to a hydroxyethylcellulose (HEC) gel formulation. Dermal bioavailability was also enhanced when galenic formulations were prepared with higher pH (7.5 vs. 6.5) or higher drug concentration (5% vs. 1%) in HEC gel. CONCLUSION: It seems possible, using CM for topical skin penetration testing in anaesthetized domestic pigs, to test the bioavailability of newly designed drugs. However, the experimental time is limited due to the anaesthesia, and is dependent on drug recovery. Validation of this technique for routine use is challenging, and more experiments are needed to validate this preclinical set-up.
Assuntos
Dipeptidil Peptidases e Tripeptidil Peptidases/antagonistas & inibidores , Microdiálise , Absorção Cutânea , Administração Cutânea , Animais , Disponibilidade Biológica , Composição de Medicamentos , Ensaios Enzimáticos , Modelos Animais , Projetos Piloto , SuínosRESUMO
Acne has been estimated to affect the majority of people at some point in their life and is common in Middle Eastern countries. While acne is frequently perceived to be a self-limited disease of adolescence, there is an increasing population of adults with acne. Information about the management of acne in the Middle East is somewhat sparse; however, several studies have recently been conducted and will be discussed in this supplement.
Assuntos
Acne Vulgar/terapia , Acne Vulgar/diagnóstico , Acne Vulgar/epidemiologia , Acne Vulgar/fisiopatologia , Adolescente , Adulto , Diagnóstico Diferencial , Feminino , Humanos , Masculino , Oriente Médio/epidemiologia , Educação de Pacientes como Assunto , Fatores de Risco , Adulto JovemRESUMO
BACKGROUND: Acne is a chronic dermatological disease predominantly afflicting young adults and is often associated with the development of scars. Acne scarring is usually avoidable when acne is managed early and effectively. However, acne patients often fail to seek early treatment. New and innovative tools to raise awareness are needed. OBJECTIVE: This study presents the development and assessment of a tool aiming to assess the risk of atrophic acne scars. METHODS: A systematic literature review of clinical risk factors for acne scars, a Delphi-like survey of dermatological experts in acne and secondary data analysis, were conducted to produce an evidence-based risk assessment tool. The tool was assessed both with a sample of young adults with and without scars and was assessed via a database cross-validation. RESULTS: A self-administered tool for risk assessment of developing atrophic acne scars in young adults was developed. It is a readily comprehensible and practical tool for population education and for use in medical practices. It comprises of four risk factors: worst ever severity of acne, duration of acne, family history of atrophic acne scars and lesion manipulation behaviours. It provides a dichotomous outcome: lower vs. higher risk of developing scars, thereby categorizing nearly two-thirds of the population correctly, with sensitivity of 82% and specificity of 43%. CONCLUSION: The present tool was developed as a response to current challenges in acne scar prevention. A potential benefit is to encourage those at risk to self-identify and to seek active intervention of their acne. In clinical practice, we expect this tool may help clinicians identify patients at risk of atrophic acne scarring and underscore their requirement for rapid and effective acne treatment.
Assuntos
Acne Vulgar/complicações , Cicatriz/complicações , Adulto , Algoritmos , Medicina Baseada em Evidências , Feminino , Humanos , Masculino , Medição de Risco , Índice de Gravidade de Doença , Adulto JovemRESUMO
BACKGROUND: Epidermal stem cells are multipotent cells that maintain the skin epidermis. Potential markers for stem cells have been identified in mammalian skin from mouse experiments; however, it is unclear if stem cells also contribute to tumour formation in human skin. OBJECTIVES: To investigate the expression of potential stem cell markers, such as leucine-rich repeat-containing G protein-coupled receptor (Lgr) 5, Lgr6, leucine-rich repeats and immunoglobulin-like domain protein 1 (Lrig1) and cytokeratin 15 (CK15) in basal cell carcinomas and tumours of the skin appendages. METHODS: We tested 45 human basal cell carcinomas (BCCs), including superficial, nodular, adenoid, infiltrating and sclerosing types, and 38 human tumours of skin appendages, including 13 sebaceous adenomas and carcinomas, 20 eccrine sweat gland tumours and five pilomatricomas, for the expression of hair follicle stem cell markers such as Lgr5, Lrig1, CK15, ß-catenin and SRY (sex determining region Y)-box 9 (SOX9), and compared these findings with those of healthy age-matched human epidermis. RESULTS: We detected the expression of stem cell markers in all tumours tested. Regarding Lgr5, Lrig1, CK15 and SOX9, expression seemed to be lower in more aggressive tumour types, such as in the most advanced parts of infiltrating BCC, in sebaceous carcinoma and late-stage porocarcinoma, compared with less aggressive superficial or nodular BCC or early-stage porocarcinoma and sebaceous gland tumours. In aggressive, sclerosing BCC, Lrig1 and Lgr5 were downregulated but CK15, SOX9 and nuclear ß-catenin were upregulated. CONCLUSIONS: Expression of potential stem cell markers of the epidermis and hair follicles was observed in skin tumours of appendages and BCCs. However, during tumour progression, many of these markers seemed to be downregulated.
Assuntos
Biomarcadores Tumorais/metabolismo , Carcinoma Basocelular/metabolismo , Neoplasias Cutâneas/metabolismo , Células-Tronco/metabolismo , Regulação para Baixo/fisiologia , Epiderme/metabolismo , Doenças do Cabelo/metabolismo , Folículo Piloso/metabolismo , Humanos , Queratina-15/metabolismo , Glicoproteínas de Membrana/metabolismo , Pilomatrixoma/metabolismo , Receptores Acoplados a Proteínas G/metabolismo , Fatores de Transcrição SOX9/metabolismo , Neoplasias das Glândulas Sebáceas/metabolismo , Neoplasias das Glândulas Sudoríparas/metabolismo , Regulação para Cima/fisiologia , beta Catenina/metabolismoRESUMO
AIMS: The aim of this pilot study was to use microdialysis to evaluate levels of Methotrexate (MTX) directly in psoriatic skin following oral or subcutaneous administration of MTX to elaborate a complete pharmacokinetic profile within the dermal skin. METHODS: Six patients with chronic plaque psoriasis on the arm undergoing treatment with MTX were included in a mono-centre clinical trial. Patients were under treatment with p.o. or s.c. MTX (7.5 and 15 mg) for at least 3 months. Interstitial fluid was collected ex vivo via dermal microdialysis from lesional or non-lesional skin and via intravenous microdialysis as well as blood serum every hour up to 10 h after methotrexate administration every hour. MTX was analysed via liquid chromatography. RESULTS: The area under the curve (AUC) of methotrexate from peripheral blood was up to four times higher than from microdiaylsis, which detection of free unbound MTX. The AUC from dialysates in psoriatic lesional skin was higher than in non-lesional psoriatic skin, and the AUC levels from i.v. microdialysis were non-significantly higher than those from lesional psoriatic skin. Pharmacokinetic profiles were individually quite different and did not primarily depend on the dose or the means (p.o. vs. s.c.) in which it was administered. CONCLUSION: Dermal microdialysis is a valid tool to evaluate levels of methotrexate in the skin of psoriasis patients. Drug levels and bioavailability of methotrexate were higher in lesional than non-lesional psoriatic skin. The individual AUC of MTX was not primarily dependent on the route or dose of administration.
Assuntos
Fármacos Dermatológicos/farmacocinética , Metotrexato/farmacocinética , Psoríase/tratamento farmacológico , Administração Oral , Adulto , Idoso , Disponibilidade Biológica , Fármacos Dermatológicos/administração & dosagem , Humanos , Injeções Subcutâneas , Metotrexato/administração & dosagem , Microdiálise , Pessoa de Meia-Idade , Psoríase/metabolismoRESUMO
BACKGROUND: Many current guidelines provide detailed evidence-based recommendations for acne treatment. OBJECTIVE: To create consensus-based, simple, easy-to-use algorithms for clinical acne treatment in daily office-based practice and to provide checklists to assist in determining why a patient may not have responded to treatment and what action to take. METHODS: Existing treatment guidelines and consensus papers were reviewed. The information in them was extracted and simplified according to daily clinical practice needs using a consensus-based approach and based on the authors' clinical expertise. RESULTS: As outcomes, separate simple algorithms are presented for the treatment of predominant comedonal, predominant papulopustular and nodular/conglobate acne. Patients with predominant comedonal acne should initially be treated with a topical retinoid, azelaic acid or salicylic acid. Fixed combination topicals are recommended for patients with predominant papulopustular acne with treatment tailored according to the severity of disease. Treatment recommendations for nodular/conglobate acne include oral isotretinoin or fixed combinations plus oral antibiotics in men, and these options may be supplemented with oral anti-androgenic hormonal therapy in women. Further decisions regarding treatment responses should be evaluated 8 weeks after treatment initiation in patients with predominant comedonal or papulopustular acne and 12 weeks after in those with nodular/conglobate acne. Maintenance therapy with a topical retinoid or azelaic acid should be commenced once a patient is clear or almost clear of their acne to prevent the disease from recurring. The principal explanations for lack of treatment response fall into 5 main categories: disease progression, non-drug-related reasons, drug-related reasons, poor adherence, and adverse events. CONCLUSION: This practical guide provides dermatologists with treatment algorithms adapted to different clinical features of acne which are simple and easy to use in daily clinical practice. The checklists to establish the causes for a lack of treatment response and subsequent action to take will facilitate successful acne management.
Assuntos
Acne Vulgar/terapia , Fármacos Dermatológicos/uso terapêutico , Guias de Prática Clínica como Assunto , Algoritmos , Consenso , HumanosRESUMO
Acne is a chronic disease of the pilosebaceous unit which is most common during adolescence. Four factors are believed to play a key role in the development of acne lesions: excess sebum production, disturbed keratinization within the follicle, colonization of the pilosebaceous duct by Propionibacterium acnes, and the release of inflammatory mediators into the skin. Consequently, in order to effectively and rapidly reduce acne lesions, treatments need to address as many of these underlying factors as possible. Currently, about half of patients have poor adherence to acne treatments. To overcome this limitation, treatments need to be developed which are well tolerated by patients, and easy for them to use, handle and apply. Topical monotherapies for acne such as retinoids and antimicrobials by themselves have a restricted range of actions against the pathogenic factors of acne. Instead, the Global Alliance to Improve Outcomes in Acne Group recommends combination therapy with a topical retinoid and an antimicrobial agent as the preferred approach for almost all acne patients. The principal advantage of such combinations is that they target more of the underlying pathogenic factors of acne than individual monotherapies and this results in faster and more complete clearing of acne lesions. Fixed-dose combinations are also more convenient than applying two medications separately, which leads to improved adherence with the regimen. By normalizing desquamation, the retinoid component of these combinations allows entry of the antimicrobial agent into the pilosebaceous unit resulting in faster clearance of P. acnes. In conclusion, topical retinoid/antimicrobial fixed-dose combinations represent a rational approach for the treatment of acne. They should be considered as the cornerstone of acne management and should be used much more in the future.
Assuntos
Acne Vulgar/tratamento farmacológico , Acne Vulgar/fisiopatologia , Acne Vulgar/etiologia , Acne Vulgar/patologia , Antibacterianos/administração & dosagem , Antibacterianos/uso terapêutico , Peróxido de Benzoíla/uso terapêutico , Fármacos Dermatológicos/administração & dosagem , Fármacos Dermatológicos/uso terapêutico , Combinação de Medicamentos , Humanos , Queratinócitos/patologia , Fotoquimioterapia , Retinoides/administração & dosagem , Retinoides/uso terapêutico , Resultado do TratamentoRESUMO
BACKGROUND: The occurrence and number of melanocytic nevi (MN) are among the most important known risk factors for the development of cutaneous melanoma (CM). OBJECTIVES: To estimate the prevalence of MN among schoolchildren and its relationship with phenotype, body mass index (BMI), parental and sun exposure factors. METHODS: A cross-sectional study was conducted on N = 1277 schoolchildren aged 7-19 years old in Kaunas city, Lithuania. Subjects were interviewed using a self-administered questionnaire and were assessed by a dermatologist. MN of all sizes and ≥2 mm in diameter were counted; phenotypic features and skin phototype were defined. BMI and body surface area (BSA) were calculated. Whole-body MN counts were expressed both as totals and as counts per unit of BSA - MN density (MND). Biological parents completed questionnaires regarding nevus counts, family history of skin cancer and CM. RESULTS: The numbers of all sizes and ≥2 mm MN increased according to age, respectively, from median values of 44 (IQR 28, 60) and 5 (IQR 2, 8) at the age of 7-9 years to 85 (IQR 55, 128) and 16 (IQR 8, 30) at the age of 16-19 years. A higher MND was found in children with light skin colour (P < 0.001), I-II skin phototype (P < 0.001), extensive facial freckling (P < 0.005) and multiple nevi on the father's and mother's arms (P < 0.05). 20.2% of pupils were overweight or obese, 130 males and 118 females. Overweight and obese children had a higher all sizes MND (P = 0.033, P = 0.044). Acquired suntan at the end of summer was associated with a higher all sizes MND (P < 0.05), outdoor activities at midday - with a higher ≥2 mm MND (P = 0.047) respectively. CONCLUSIONS: The prevalence of MN among schoolchildren is age-dependent and strongly determined by skin colour, skin phototype, facial freckling and BMI. Parental nevus numbers, acquired suntan and outdoor activities at midday must be considered.
Assuntos
Nevo Pigmentado/epidemiologia , Neoplasias Cutâneas/epidemiologia , Adolescente , Índice de Massa Corporal , Criança , Estudos Transversais , Feminino , Humanos , Lituânia/epidemiologia , Masculino , Nevo Pigmentado/genética , Pais , Fenótipo , Prevalência , Neoplasias Cutâneas/genética , Luz Solar/efeitos adversos , Inquéritos e Questionários , Adulto JovemAssuntos
Dermatologia , Internato e Residência , Dermatopatias , Dermatologia/educação , Humanos , Pele , Pigmentação da PeleRESUMO
BACKGROUND: Growing numbers of post-adolescent females are suffering from treatment-resistant or relapsing adult acne forms, therefore requiring the definition of safe and effective treatment options for this burdening disease. OBJECTIVES: To assess the efficacy of azelaic acid 15% gel (AzA) vs. no treatment during maintenance therapy of female adult acne and to compare its efficacy and safety vs. adapalene 0.1% gel (AD) during a 9-month period (3-month treatment and 6-month maintenance treatment). METHODS: A total of 55 women between 18 and 45 years with adult acne were included in this investigator-blind trial and randomized into three groups receiving AzA gel b.i.d. for 9 months (AzA9M, n = 17) or AzA gel b.i.d. for 3 months followed by a 6-month observational phase (AzA3M, n = 19) or AD gel once daily for 9 months (AD9M, n = 19). Parameters of efficacy, safety and patient-related factors were analysed. RESULTS: The reduction in lesion counts, severity and Dermatology Life Quality Index score was significant (P < 0.05) and comparable between groups during the treatment phase, while dryness and scaling were significantly lower (P < 0.05) in group AzA9M vs. AD9M. During maintenance, AzA9M was superior to AzA3M in the control of inflammatory lesions (P = 0.008) and total lesions (P = 0.014) at week 24. From week 12 to week 36, a mild relative increase in inflammatory lesions could be observed in all groups. In AzA3M, this increase exceeded that of AzA9M by 23.1% (P = 0.109), while the difference of total lesions diverged to 30.8% (P = 0.038). No significant differences could be detected between AzA9M and AD9M. Group AzA9M was non-inferior to AD9M (non-inferiority margin of 50% for the confidence limit for the relative effect) in the control of inflammatory acne lesions. CONCLUSIONS: AzA15% gel is a safe and effective treatment and maintenance treatment of female adult acne with non-inferior efficacy to AD 0.1% gel in the control of inflammatory acne.
Assuntos
Acne Vulgar/tratamento farmacológico , Adapaleno/administração & dosagem , Fármacos Dermatológicos/administração & dosagem , Ácidos Dicarboxílicos/administração & dosagem , Adapaleno/efeitos adversos , Adulto , Fármacos Dermatológicos/efeitos adversos , Ácidos Dicarboxílicos/efeitos adversos , Feminino , Géis , Humanos , Quimioterapia de Manutenção/métodos , Índice de Gravidade de Doença , Método Simples-Cego , Adulto JovemRESUMO
Acne has long been understood to have a complex physiological basis involving several main factors: hormonally-stimulated sebum production, abnormal keratinization of the pilosebaceous duct, and an inflammatory immune response to Propionibacterium acnes. Recent studies at the molecular and cellular level have begun clarifying how all of these factors interact, and the role of the innate immune system is better appreciated. Inflammation has been demonstrated in all acne lesions - the preclinical microcomedo, comedones, inflammatory lesions, 'post-inflammatory' erythema or hyperpigmentation, and scarring. Inflammation localized to the pilosebaceous unit can be considered the defining feature of acne and should be addressed via multiple therapeutic pathways. Clinicians tend to think oral antibiotics should be used to 'calm' inflammatory acne, but there is good evidence showing that topical retinoids also have anti-inflammatory properties as a class effect. For best therapeutic outcomes, most patients with acne should be treated first line with a topical retinoid plus an antimicrobial agent, as has been demonstrated in thousands of patients involved in clinical trials and recommended by the Global Alliance to Improve Outcomes in Acne for more than a decade. Moving away from reliance on antibiotic therapy for acne is particularly important in an era of worsening antimicrobial resistance and worldwide calls to reduce antibiotic use. Improved understanding about the role of P. acnes and the innate immune system in acne should help clinicians in designing efficacious treatment strategies.
Assuntos
Acne Vulgar/tratamento farmacológico , Acne Vulgar/etiologia , Infecções por Bactérias Gram-Positivas/complicações , Imunidade Inata , Propionibacterium acnes/imunologia , Retinoides/imunologia , Antibacterianos/uso terapêutico , Infecções por Bactérias Gram-Positivas/imunologia , Folículo Piloso , Humanos , Inflamassomos , Inflamação/imunologia , Retinoides/uso terapêutico , Receptores Toll-Like/metabolismoRESUMO
BACKGROUND: Acne is a chronic inflammatory disease requiring long-term treatment. The fixed-dose combination adapalene 0.1%/benzoyl peroxide 2.5% (adapalene-BPO) is indicated for the once-daily topical treatment of Acne vulgaris when comedones, papules and pustules are present. OBJECTIVE: The main objectives of this non-interventional study were to assess long-term efficacy and safety of adapalene-BPO in moderate to severe acne with and without concomitant medication. METHODS: Patients with moderate to severe acne received adapalene-BPO alone or in combination with concomitant medication over a course of 9 months. The primary efficacy endpoint was changes in acne severity according to the Leeds Revised Acne Grading System; secondary endpoints included treatment success assessed by the patient and safety. RESULTS: In total, 5131 patients were eligible for efficacy and 5141 for safety evaluation. The majority of patients (78.8%) received adapalene-BPO alone. About 21.2% received adapalene-BPO in combination with another agent, mostly topical antibiotics (8.8%) or systemic antibiotics (8.7%). Mean (±SD) acne severity improved from 5.6 ± 1.5 at baseline to 3.3 ± 1.9 at month 3, and further to 1.9 ± 1.9 at month 9 (both P < 0.0001). The degree of improvement correlated significantly with the severity at baseline. After 3 and 9 months of treatment, the facial skin was cleared completely (no more visible acne lesions) in 420 (8.2%) and 1326 patients (25.8%), respectively. A therapeutic effect was noted by the patients after a median time of 3 weeks (range: from 1 day to 12 weeks). No serious adverse events were reported. Facial skin irritations, mostly mild to moderate, occurred in 49.5% of patients and led to discontinuation in only 1.7% of cases. CONCLUSION: In consistence with previous clinical findings, the use of adapalene-BPO in daily practice routine is safe and effective in the long-term management of patients with moderate to severe acne.
Assuntos
Acne Vulgar/tratamento farmacológico , Adapaleno/uso terapêutico , Peróxido de Benzoíla/uso terapêutico , Dermatoses Faciais/tratamento farmacológico , Adapaleno/efeitos adversos , Administração Cutânea , Adolescente , Adulto , Idoso , Antibacterianos/uso terapêutico , Peróxido de Benzoíla/efeitos adversos , Criança , Dermatite Irritante/etiologia , Combinação de Medicamentos , Quimioterapia Combinada , Eritema/induzido quimicamente , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Índice de Gravidade de Doença , Fatores de Tempo , Adulto JovemRESUMO
BACKGROUND: In addition to physical long-lasting effects such as permanent scarring and disfigurement, acne has acute and long-term psychosocial effects that affect the individual's quality of life. As with other chronic diseases, treatment success is often compromised by poor adherence. OBJECTIVE: Two main objectives of this non-interventional study were to assess the long-term effect of the fixed-dose combination adapalene 0.1%/benzoyl peroxide 2.5% (adapalene-BPO gel) on quality of life and treatment adherence. METHODS: Patients with moderate to severe facial acne receiving adapalene-BPO alone or in combination with other drugs were enrolled in this non-interventional study. Data were documented at baseline and after 3 and 9 months of adapalene-BPO treatment. The secondary outcomes reported here include quality of life determined by the Cardiff Acne Disability Index (CADI), treatment adherence assessed by the ECOB (Elaboration d'un outil d'evaluation de l'observance des traitements medicamenteux) questionnaire, and patient satisfaction. RESULTS: In total, 5131 patients were included in the efficacy evaluation. After 9 months, mean (±SD) quality of life (CADI) improved significantly from 5.9 ± 3.0 to 2.4 ± 2.7 (P < 0.0001). Patients with more severe acne at baseline tended to achieve a greater improvement in quality of life. Long-term adherence was found to be good in 83.9% of patients. Adherence had a significant effect on efficacy and quality of life (P < 0.0001 respectively). The vast majority of patients (92.1%) reported subjective improvement at the interim analysis. Accordingly, most patients (84.8%) were satisfied or very satisfied with adapalene-BPO by the end of the observation period. CONCLUSION: The clinical improvement of the disease led to an increase in quality of life among acne patients. The treatment success may be a motivation factor for patients to stay adherent over the long-term treatment course, indicating the qualification of adapalene-BPO topical gel as an appropriate medication also in the long-term usage.
Assuntos
Acne Vulgar/tratamento farmacológico , Adapaleno/uso terapêutico , Peróxido de Benzoíla/uso terapêutico , Dermatoses Faciais/tratamento farmacológico , Adesão à Medicação/estatística & dados numéricos , Qualidade de Vida/psicologia , Acne Vulgar/psicologia , Adapaleno/administração & dosagem , Administração Cutânea , Adolescente , Adulto , Idoso , Antibacterianos/uso terapêutico , Peróxido de Benzoíla/administração & dosagem , Criança , Combinação de Medicamentos , Quimioterapia Combinada , Dermatoses Faciais/psicologia , Feminino , Géis , Humanos , Masculino , Pessoa de Meia-Idade , Satisfação do Paciente , Estudos Prospectivos , Índice de Gravidade de Doença , Inquéritos e Questionários , Fatores de Tempo , Adulto JovemRESUMO
BACKGROUND: Acne is one of the most common chronic inflammatory dermatological diseases among adolescents. OBJECTIVES: We sought to estimate the prevalence of acne among schoolchildren and its association with puberty, body mass index (BMI), acne history of parents, nutritional habits, smoking and alcohol consumption. METHODS: A cross-sectional study was conducted on 1277 pupils aged 7-19 years. Children were interviewed with self-administered questionnaires, and were subsequently examined by one specially trained dermatologist. To evaluate the onset of puberty, girls provided details about their menarche and boys--about their facial hair growth. RESULTS: The overall response rate of the study was 51.4%. The prevalence of acne among respondents was 82.9%, and was strongly age-dependent with highest rates in the age groups of 13-15 and 16-19 years. The prevalence of pre-pubertal acne among participating girls and boys was 69.9% and 73.6% respectively. The main risk factors of acne were facial hair growth in boys (OR = 4.9), menarche in girls (OR = 3.1), overweight/obesity (BMI ≥ 25 kg/m(2) at 18 years of age) (OR = 2.6), acne history from both parents (OR = 2.6) and from mother alone (OR = 2.1). We did not find any associations between acne and nutritional habits, smoking or alcohol consumption. The self-reported prevalence of acne among children who refused to take part in the study was lower than that among participants of the study. CONCLUSIONS: The overall prevalence of acne among schoolchildren is high and age-dependent. The onset of puberty, overweight/obesity and history of acne from both parents are the top risk factors for acne.