Ocular surface changes in the treatment of rosacea: comparison between low-dose oral isotretinoin and doxycycline / Alterações da superfície ocular no tratamento da Rosácea: comparação entre isotretinoína oral em baixa dosagem e doxiciclina

ABSTRACT Purpose: To compare the impact of ocular changes between systemic treatment with doxycycline and low-dose oral isotretinoin in patients with moderate-to-severe papulopustular rosacea. Methods: Patients were randomized to receive either isotretinoin 0.3-0.4 mg/kg (group A) or doxycycline 100 mg/day (group B) for 16 weeks. Ocular symptoms were searched and evaluated, including best-corrected visual acuity (BCVA), Schirmer test, breakup time, rose bengal staining score, and meibomian gland dysfunction grading. The patients were retested at the end of treatment. Results: The present study included 39 patients (30 females and 9 males). Best-corrected visual acuity was > 20/30 in >90% of patients in both groups and did not change after treatment. After treatment, improvement in ocular symptoms and meibomian gland dysfunction was more pronounced in group B (p<0.05); the other parameters did not reach statistical significance. Conclusion: Doxycycline improved meibomian gland dysfunction, ocular symptoms, and ocular surface in patients with rosacea. Even though some patients experienced worsening meibomian gland dysfunction and symptoms, no subject experienced any serious complications after administration of low-dose isotretinoin.

RESUMO Objetivos: Comparar o impacto das alterações oculares entre o tratamento sistêmico de doxiciclina e isotretinoína em baixa dosagem em pacientes com rosácea papulopustulosa moderada a grave. Métodos: Os pacientes form randomizados para receber isotretinoína 0,3 a 0,4 mg/kg (grupo A) ou doxiciclina 100mg/dia (grupo B) por 16 semanas. Os sintomas oculares foram pesquisados e avaliados, incluindo melhor acuidade visual corrigida, teste de Schirmer, tempo de ruptura do filme lacrimal, coloração de rosa bengala e graduação da disfunção de glândula de Meibomius. Os pacientes foram novamente testados no final do tratamento. Resultados: O presente estudo incluiu 39 pacientes (30 mulheres e 9 homens). A melhor acuidade visual corrigida foi >20/30 em >90% dos pacientes em ambos os grupos e não se alterou após o tratamento. A melhora dos sintomas oculares e da disfunção de glândula de Meibomius foi mais pronunciada no grupo B (p<0,05) após o tratamento; as demais variáveis não atingiram significância estatística. Conclusão: A doxiciclina melhorou a disfunção de glândula de Meibomius, os sintomas oculares e a superfície ocular de pa cientes com rosácea. Mesmo que alguns pacientes tenham piorado a disfunção e os sintomas da glândula de Meibomius, nenhum indivíduo apresentou complicações graves após a admi nistração de baixas doses de isotretinoína.

Rosacea-specific quality of life questionnaire: translation, cultural adaptation and validation for Brazilian Portuguese

Abstract: Background: Brazil does not have a rosacea-specific quality of life questionnaire. Objectives: translation into Brazilian Portuguese, development of cultural adaptation, and validation of the RosaQoL disease-specific questionnaire for rosacea of any subtype. Methods: the recommended procedures for translation, cultural adaptation, and validation of an instrument were followed, and three interviews were conducted: baseline; seven to fourteen days after baseline; and at four to six months. The questionnaire was analyzed (with 95% confidence interval) for reliability by internal consistency (Cronbach's alpha); testretest reproducibility (intraclass correlation coefficient); responsiveness and validity. Results: terms of the original questionnaire were replaced to guarantee cultural and semantic equivalence. Validity was demonstrated by expressive correlations between the RosaQoL domains and by significance in the Jonckheere-Terpstra test (p≤0.05) between the scores of the RosaQoL domains and the participants' self-perception in relation to the disease. Reliability was acceptable; alpha coefficient ranged from 0.923 to 0.916 in the first and second applications of the RosaQoL, respectively, and the Intraclass Correlation Coefficient (ICC) ranged from 0.671 to 0.863 in the seven- to fourteen-day period. Responsiveness, measured by grouping participants into three categories based on self-perception of rosacea (better, worse or unchanged), was found for the "better" response group (p≤0.05). Study limitations: small sample; limited variety of screening sources. Conclusions: RosaQoL-BR (Brazil) was demonstrated as a reliable, valid and responsive questionnaire, with limitations, for individuals with any subtype of rosacea.

Tratamento da acne vulgar moderada a grave com isotretinoína oral similar ao produto referência / Treatment of moderate to severe acne vulgaris with an oral isotretinoin similar to the reference product

Introdução: Acne vulgar é doença inflamatória crônica dos folículos pilossebáceos. O tratamento deve ser precoce e efetivo para evitar cicatrizes e repercussões psicossociais, sendo a isotretinoína droga de escolha para casos moderados ou graves. Objetivos: Avaliar eficácia, segurança e tolerabilidade de uma isotretinoína similar ao produto referência. Métodos: Estudo bicêntrico, de intervenção terapêutica, incluindo 50 participantes, de 13 a 35 anos de idade, com acne moderada ou grave, usando isotretinoína 0,5mg/kg/dia, até 120mg/kg. A eficácia foi avaliada por meio da contagem de lesões, escala de avaliação global do investigador (IGA), satisfação do paciente e aplicação do questionário de qualidade de vida específico para acne (Acne Qol). Segurança e tolerabilidade foram avaliadas pela análise de eventos adversos e por exames laboratoriais. Resultados: A idade média foi 20 anos, sendo 70% homens, com redução de 99% das lesões ao final do tratamento e remissão total das lesões em 91,5% dos participantes. A escala IGA reduziu 98% no escore ao final do tratamento. Todos os pacientes se declararam satisfeitos, com significativa melhora na qualidade de vida. Os eventos adversos foram semelhantes aos descritos na literatura. Conclusões: A isotretinoína avaliada mostrou-se igualmente eficaz, segura e bem tolerada quando comparada aos dados publicados referentes ao produto-padrão.

Introduction: Acne vulgaris is a chronic inflammatory disease of the pilosebaceous follicles. Treatment should be early and effective to prevent scarring and psychosocial effects, and isotretinoin is the drug of choice for moderate or severe cases. Objective: To assess efficacy, safety and tolerability of an isotretinoin similar to the reference product. Methods: A bicentric study, with therapeutic intervention was conducted, including 50 participants aged 13 to 35 years, with moderate to severe acne, using isotretinoin 0.5 mg/kg/day up to 120 mg/kg. Efficacy was assessed through lesions counting, the investigator's global assessment (IGA) scale, patient satisfaction and application of the quality of life questionnaire specific for Acne (Acne Qol). Safety and tolerability were assessed by analysis of adverse events and laboratory tests. Results: Mean age was 20 years, 70% of participants were men, with a reduction of 99% of lesions after treatment and complete remission of lesions in 91.5% of participants. IGA scale reduced 98% in the score after treatment. Also, 100% of participants declared to be satisfied, with significant improvement in quality of life. Adverse events were similar to those described in the literature. Conclusion: The assessed isotretinoin was equally effective, safe and well-tolerated when compared with published data of the standard product.

Acne-specific quality of life questionnaire (Acne-QoL): translation, cultural adaptation and validation into Brazilian-Portuguese language

BACKGROUND: many studies about the psychosocial impact of acne have been reported in international medical literature describing quality of life as a relevant clinical outcome. It is well known that the patient's perception about the disease may be different from the physician's evaluation. Therefore, it is important to use validated instruments that turn the patient's subjective opinion into objective information. OBJECTIVES: to translate into Brazilian-Portuguese language and to culturally adapt a quality of life questionnaire, the Acne-Specific Quality of Life Questionnaire (Acne-QoL), as well as to evaluate its reliability and validity. METHODS: measurement properties were assessed: 1) validity: comparison between severity and Acne-QoL domain scores, correlations between acne duration and Acne-QoL domain scores, and correlation between Acne-QoL domain scores and SF-36 components; 2) internal consistency: Cronbach's α coefficient; 3) test-retest reproducibility: intraclass correlation coefficient and Wilcoxon test. RESULTS: Eighty subjects with a mean age of 20.5 ± 4.8 years presenting mild (33.8%), moderate (36.2%) and severe (30%) facial acne were enrolled. Acne-QoL domain scores were similar among the different acne severity groups except for role-social domain. Subjects with shorter acne duration presented significant higher scores. Acne-QoL domains showed significant correlations, both between themselves and with SF-36 role-social and mental health components. Internal consistency (0.925-0.952) and test-retest reproducibility were considered acceptable (0.768-0.836). CONCLUSIONS: the Brazilian-Portuguese version of the Acne-QoL is a reliable and valid satisfactory outcome measure to be used in facial acne studies. .

Síndrome do ovário policístico: abordagem dermatológica / Polycystic ovary syndrome: a dermatologic approach

A síndrome do ovário policístico (SOP) é uma das endocrinopatias mais freqüentes nas mulheres em idade reprodutiva. Caracteriza-se por morbidade elevada devido aos aspectos estéticos e por repercussões metabólicas importantes. Embora a sua patogênese permaneça incompletamente conhecida, acredita-se numa desordem multigênica complexa, incluindo anormalidades no eixo hipotálamohipofisário, esteroidogênese e resistência insulínica. Os achados principais para o diagnóstico são: hiperandrogenismo, anovulação crônica e ovários policísticos à ultrassonografia. As manifestações dermatológicas do hiperandrogenismo incluem: hirsutismo, acne, seborréia, alopecia e, em casos mais graves, sinais de virilização. Existe considerável heterogeneidade nos achados clínicos e também pode haver variação na mesma paciente com o passar do tempo. O tratamento visa reduzir as manifestações do hiperandrogenismo, restaurar os ciclos ovulatórios regulares e corrigir a síndrome metabólica. Este artigo apresenta revisão da fisiopatologia, diagnóstico e tratamento da síndrome do ovário policístico. Enfatiza-se a importância do diagnóstico e tratamento precoces no intuito de prevenir as complicações metabólicas e a repercussão emocional que afeta a qualidade de vida das pacientes.

Polycystic ovary syndrome (POS) is one of the most common endocrine abnormalities affecting women of reproductive age. It is a cause of significant social embarrassment and emotional distress. The pathogenesis of the disease is not yet fully understood, but it is thought to be a complex multigenic disorder, including abnormalities in the hypothalamic-pituitary axis, steroidogenesis, and insulin resistance. The main diagnostic findings of the syndrome are: hyperandrogenism, chronic anovulation and polycystic ovarian morphology seen on ultrasound. Hyperandrogenism is generally manifested as hirsutism, acne, seborrhea, androgenic alopecia and, in severe cases, signs of virilization. Treatment may improve the clinical manifestations of excess androgen production, normalize menses and ameliorate metabolic syndrome and cardiovascular complications. This article reviews the diagnosis, clinical manifestations, metabolic complications, and treatment of the syndrome. Early diagnosis and the consequent early treatment may prevent metabolic complications and emotional distress that negatively impact the patients' quality of life.